Principal Regulatory Affairs Specialist
for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Use - for any list of duties/requirements/benefits, and
for prose. Do NOT repeat job title as heading. Do NOT put Job ID / requisition numbers as headings — fold minor metadata into short
or drop it. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. Include a section ONLY when posting has real, specific content for it — never emit heading followed by filler/placeholder text (e.g., "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless posting actually states them. Prefer a few substantive sections over many thin ones.
We need to parse the posting: It has company overview repeated, then "The Opportunity That Awaits You: The Principal Regulatory Affairs Specialist provides regulatory leadership..." Then "What Your Day-To-Day Will Involve:" with many bullet-like sentences separated by spaces? Actually it's a long paragraph with many responsibilities separated by no punctuation? Let's extract responsibilities list.
Then "The Qualifications We Need You To Possess To perform this job successfully..." then "Qualifications / Skills Required" with list.
No explicit Benefits, Pay, Schedule sections. So we should not create those sections.
We need sections: maybe "About the role" (or "Overview")? The posting includes "Company Overview" repeated. We can put an "About the role" section summarizing the role description (the opportunity). Then "Responsibilities" for day-to-day tasks. Then "Qualifications" (or "Requirements") for qualifications/skills.
We must not repeat job title as heading. So headings like
About the role
, Responsibilities
, Qualifications
. Possibly also "Skills" but we can combine qualifications and skills.
We need to use - for any list of duties/requirements/benefits. So responsibilities list should be
- each item. Qualifications list also
- .
We need to preserve all substantive information; do not invent or summarize away detail. So we need to include each responsibility sentence as separate list item? The responsibilities are a long paragraph with many items separated by spaces but we can split by verbs? Better to keep as one paragraph? But rule says use
- for any list of duties/requirements/benefits. So we need to convert responsibilities into list items. We must not lose any detail. So we need to split the responsibilities into distinct items. Let's parse the responsibilities text:
"Regulatory representation and leadership to cross-functional products teams, development of regulatory strategies and support PROCEPT’s products, marketing applications and post-market activitiesProviding training, coaching and mentoring to other regulatory affairs specialistsAssisting in strategic decision making, and representing regulatory at all levels of the businessResponsible for project timelines and management of regulatory submissions including preparing IDE, 510K and international submissions for new products, new indications, and significant product changes, to ensure compliance with the FDA and international regulations and guidelinesPrepare Letters to File documentation to support internal filings for product development projects and product changes not requiring regulatory agency approvalsPrepare and maintain Technical Files/Technical Documentation for Europe (CE Mark) for new products, new indications, and significant product changesSupport product development teams on regulatory issues, including review of documentationProvide regulatory assessments for anticipated design, manufacturing, and labeling changesRepresent RA functional area in the review and approval of Engineering Change Orders (ECO)Provide regulatory guidance with regard to the preparation, review and approval of labeling and promotional materialsPerform regulatory research and stay abreast of changes for US and international regulations and requirementsProvide regulatory support for quality assurance and regulatory compliance activities as requiredMaintain well-organized, auditable regulatory filesMaintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory complianceUnderstand and adhere to the PROCEPT BioRobotics EHS Policy"
We need to split at each capitalized verb start? Let's identify items:
1. Regulatory representation and leadership to cross-functional products teams, development of regulatory strategies and support PROCEPT’s products, marketing applications and post-market activities
2. Providing training, coaching and mentoring to other regulatory affairs specialists
3. Assisting in strategic decision making, and representing regulatory at all levels of the business
4. Responsible for project timelines and management of regulatory submissions including preparing IDE, 510K and international submissions for new products, new indications, and significant product changes, to ensure compliance with the FDA and international regulations and guidelines
5. Prepare Letters to File documentation to support internal filings for product development projects and product changes not requiring regulatory agency approvals
6. Prepare and maintain Technical Files/Technical Documentation for Europe (CE Mark) for new products, new indications, and significant product changes
7. Support product development teams on regulatory issues, including review of documentation
8. Provide regulatory assessments for anticipated design, manufacturing, and labeling changes
9. Represent RA functional area in the review and approval of Engineering Change Orders (ECO)
10. Provide regulatory guidance with regard to the preparation, review and approval of labeling and promotional materials
11. Perform regulatory research and stay abreast of changes for US and international regulations and requirements
12. Provide regulatory support for quality assurance and regulatory compliance activities as required
13. Maintain well-organized, auditable regulatory files
14. Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance
15. Understand and adhere to the PROCEPT BioRobotics EHS Policy
That seems comprehensive.
Now qualifications list: The text after "Qualifications / Skills Required" includes:
- Bachelor’s degree in a scientific discipline; advanced degree and RAC (Regulatory Affairs Certificate) preferred
- Minimum of 12 years’ experience in medical device industry with experience in regulatory affairs with direct submissions responsibilities
- Knowledge of relevant Title 21 of the US code of Federal Regulations is required
- Experience with US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k) is required
- Experience with European Medical Device Directive (93/42/EEC with 2007/47/EC) is required
- Experience with Quality Management System Standard ISO 13485 is required
- Experience with Risk Management Standard ISO 14971 is required
- Knowledge of EU MDR regulations is required
- Knowledge of International Medical Device requirements (Canada, Australia, New Zealand, China, Japan, etc.) is preferred
- Proficiency in basic computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
- Strong organization skills, able to manage multiple projects and timelines
- Competence in applying scientific principles and logical thought processes in preparing regulatory documentation
- Excellent oral and written communication skills
- Strong attention to detail
- Ability to work independently as an individual contributor and in a team environment
- Knowledge of software development and software quality as it relates to regulatory submissions a plus
We need to output as
- each.
We also need an "About the role" section: maybe a paragraph summarizing the role: The Opportunity That Awaits You: The Principal Regulatory Affairs Specialist provides regulatory leadership for product manufactured by PROCEPT BioRobotics from development through marketing approval and commercialization. Responsibilities include coordination and preparation of regulatory submissions and for the development/revision of procedures and practices to ensure compliance with FDA and international regulations, guidelines, and standards, and providing regulatory guidance to project teams. The initial role of the Principal Regulatory Affairs Specialist will be as an individual contributor, reports to the Senior Director of Global Regulatory Affairs. The ideal candidate would have had previous medical device experience and looking for potential for growth.
We can put that as
under About the role.
We must not repeat job title as heading. So we avoid heading "Principal Regulatory Affairs Specialist". Good.
We need to output only HTML fragment, no /, no markdown fences.
Thus final output:
About the role
...
Responsibilities
- ...
...
Qualifications
- ...
...
We could also have a "Skills" section but qualifications already includes skills. To avoid thin sections, we combine.
Check for any boilerplate: The posting includes repeated "Company Overview" paragraphs. We should include that as part of About the role? The instruction: Preserve ALL substantive information; do NOT invent or summarize away detail. So we need to include the company overview content as well. The company overview is substantive. Should we include it under About the role? Probably yes. The "About the role" section could include company overview plus role description. But we must not repeat duplicated lines. The company overview appears twice identical; we should include only once.
Thus About the role paragraph(s) should contain the company overview description and the opportunity description.
We can have multiple under About the role? The rule: Use
for prose. So we can have multiple paragraphs.
Thus:
About the role
Company overview text...
The Opportunity That Awaits You: ...
Now ensure we removed duplicated lines: we have company overview only once.
Now check for any other boilerplate: The posting includes "The Qualifications We Need You To Possess To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions." That's generic but still substantive? It's a standard statement. Might be considered boilerplate but it's part of qualifications section. We could include it as a preamble before the list. It's not a list item but prose. We can include as under Qualifications before the list.
Similarly, there is a line: "To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions." That's generic but we should preserve it? The instruction: Preserve ALL substantive information; do NOT invent or summarize away detail. So we should keep it. It's not boilerplate like EEO etc. It's part of the job description. So include.
Thus Qualifications section:
To perform this job successfully...
then list.
Now check for any other sections like Benefits, Pay, Schedule: none.
Now ensure we didn't include any filler like "commensurate with experience". Not present.
Now output HTML.
Let's craft the company overview text: The posting has:
"Company Overview Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities. Understanding PROCEPT's Culture At PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism. We believe in
for prose. Do NOT repeat job title as heading. Do NOT put Job ID / requisition numbers as headings — fold minor metadata into short
or drop it. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. Include a section ONLY when posting has real, specific content for it — never emit heading followed by filler/placeholder text (e.g., "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless posting actually states them. Prefer a few substantive sections over many thin ones. We need to parse the posting: It has company overview repeated, then "The Opportunity That Awaits You: The Principal Regulatory Affairs Specialist provides regulatory leadership..." Then "What Your Day-To-Day Will Involve:" with many bullet-like sentences separated by spaces? Actually it's a long paragraph with many responsibilities separated by no punctuation? Let's extract responsibilities list. Then "The Qualifications We Need You To Possess To perform this job successfully..." then "Qualifications / Skills Required" with list. No explicit Benefits, Pay, Schedule sections. So we should not create those sections. We need sections: maybe "About the role" (or "Overview")? The posting includes "Company Overview" repeated. We can put an "About the role" section summarizing the role description (the opportunity). Then "Responsibilities" for day-to-day tasks. Then "Qualifications" (or "Requirements") for qualifications/skills. We must not repeat job title as heading. So headings like
About the role
,Responsibilities
,Qualifications
. Possibly also "Skills" but we can combine qualifications and skills. We need to use- for any list of duties/requirements/benefits. So responsibilities list should be
- each item. Qualifications list also
- .
We need to preserve all substantive information; do not invent or summarize away detail. So we need to include each responsibility sentence as separate list item? The responsibilities are a long paragraph with many items separated by spaces but we can split by verbs? Better to keep as one paragraph? But rule says use
- for any list of duties/requirements/benefits. So we need to convert responsibilities into list items. We must not lose any detail. So we need to split the responsibilities into distinct items. Let's parse the responsibilities text:
"Regulatory representation and leadership to cross-functional products teams, development of regulatory strategies and support PROCEPT’s products, marketing applications and post-market activitiesProviding training, coaching and mentoring to other regulatory affairs specialistsAssisting in strategic decision making, and representing regulatory at all levels of the businessResponsible for project timelines and management of regulatory submissions including preparing IDE, 510K and international submissions for new products, new indications, and significant product changes, to ensure compliance with the FDA and international regulations and guidelinesPrepare Letters to File documentation to support internal filings for product development projects and product changes not requiring regulatory agency approvalsPrepare and maintain Technical Files/Technical Documentation for Europe (CE Mark) for new products, new indications, and significant product changesSupport product development teams on regulatory issues, including review of documentationProvide regulatory assessments for anticipated design, manufacturing, and labeling changesRepresent RA functional area in the review and approval of Engineering Change Orders (ECO)Provide regulatory guidance with regard to the preparation, review and approval of labeling and promotional materialsPerform regulatory research and stay abreast of changes for US and international regulations and requirementsProvide regulatory support for quality assurance and regulatory compliance activities as requiredMaintain well-organized, auditable regulatory filesMaintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory complianceUnderstand and adhere to the PROCEPT BioRobotics EHS Policy"
We need to split at each capitalized verb start? Let's identify items:
1. Regulatory representation and leadership to cross-functional products teams, development of regulatory strategies and support PROCEPT’s products, marketing applications and post-market activities
2. Providing training, coaching and mentoring to other regulatory affairs specialists
3. Assisting in strategic decision making, and representing regulatory at all levels of the business
4. Responsible for project timelines and management of regulatory submissions including preparing IDE, 510K and international submissions for new products, new indications, and significant product changes, to ensure compliance with the FDA and international regulations and guidelines
5. Prepare Letters to File documentation to support internal filings for product development projects and product changes not requiring regulatory agency approvals
6. Prepare and maintain Technical Files/Technical Documentation for Europe (CE Mark) for new products, new indications, and significant product changes
7. Support product development teams on regulatory issues, including review of documentation
8. Provide regulatory assessments for anticipated design, manufacturing, and labeling changes
9. Represent RA functional area in the review and approval of Engineering Change Orders (ECO)
10. Provide regulatory guidance with regard to the preparation, review and approval of labeling and promotional materials
11. Perform regulatory research and stay abreast of changes for US and international regulations and requirements
12. Provide regulatory support for quality assurance and regulatory compliance activities as required
13. Maintain well-organized, auditable regulatory files
14. Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance
15. Understand and adhere to the PROCEPT BioRobotics EHS Policy
That seems comprehensive.
Now qualifications list: The text after "Qualifications / Skills Required" includes:
- Bachelor’s degree in a scientific discipline; advanced degree and RAC (Regulatory Affairs Certificate) preferred
- Minimum of 12 years’ experience in medical device industry with experience in regulatory affairs with direct submissions responsibilities
- Knowledge of relevant Title 21 of the US code of Federal Regulations is required
- Experience with US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k) is required
- Experience with European Medical Device Directive (93/42/EEC with 2007/47/EC) is required
- Experience with Quality Management System Standard ISO 13485 is required
- Experience with Risk Management Standard ISO 14971 is required
- Knowledge of EU MDR regulations is required
- Knowledge of International Medical Device requirements (Canada, Australia, New Zealand, China, Japan, etc.) is preferred
- Proficiency in basic computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
- Strong organization skills, able to manage multiple projects and timelines
- Competence in applying scientific principles and logical thought processes in preparing regulatory documentation
- Excellent oral and written communication skills
- Strong attention to detail
- Ability to work independently as an individual contributor and in a team environment
- Knowledge of software development and software quality as it relates to regulatory submissions a plus
We need to output as
- each.
We also need an "About the role" section: maybe a paragraph summarizing the role: The Opportunity That Awaits You: The Principal Regulatory Affairs Specialist provides regulatory leadership for product manufactured by PROCEPT BioRobotics from development through marketing approval and commercialization. Responsibilities include coordination and preparation of regulatory submissions and for the development/revision of procedures and practices to ensure compliance with FDA and international regulations, guidelines, and standards, and providing regulatory guidance to project teams. The initial role of the Principal Regulatory Affairs Specialist will be as an individual contributor, reports to the Senior Director of Global Regulatory Affairs. The ideal candidate would have had previous medical device experience and looking for potential for growth.
We can put that as
under About the role. We must not repeat job title as heading. So we avoid heading "Principal Regulatory Affairs Specialist". Good. We need to output only HTML fragment, no /, no markdown fences. Thus final output:
About the role
...
Responsibilities
- ... ...
Qualifications
- ... ...
under About the role? The rule: Use
for prose. So we can have multiple paragraphs. Thus:
About the role
Company overview text...
The Opportunity That Awaits You: ...
Now ensure we removed duplicated lines: we have company overview only once. Now check for any other boilerplate: The posting includes "The Qualifications We Need You To Possess To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions." That's generic but still substantive? It's a standard statement. Might be considered boilerplate but it's part of qualifications section. We could include it as a preamble before the list. It's not a list item but prose. We can include asunder Qualifications before the list. Similarly, there is a line: "To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions." That's generic but we should preserve it? The instruction: Preserve ALL substantive information; do NOT invent or summarize away detail. So we should keep it. It's not boilerplate like EEO etc. It's part of the job description. So include. Thus Qualifications section:
To perform this job successfully...
then- list.
Now check for any other sections like Benefits, Pay, Schedule: none.
Now ensure we didn't include any filler like "commensurate with experience". Not present.
Now output HTML.
Let's craft the company overview text: The posting has:
"Company Overview Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities. Understanding PROCEPT's Culture At PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism. We believe in
- each.
We also need an "About the role" section: maybe a paragraph summarizing the role: The Opportunity That Awaits You: The Principal Regulatory Affairs Specialist provides regulatory leadership for product manufactured by PROCEPT BioRobotics from development through marketing approval and commercialization. Responsibilities include coordination and preparation of regulatory submissions and for the development/revision of procedures and practices to ensure compliance with FDA and international regulations, guidelines, and standards, and providing regulatory guidance to project teams. The initial role of the Principal Regulatory Affairs Specialist will be as an individual contributor, reports to the Senior Director of Global Regulatory Affairs. The ideal candidate would have had previous medical device experience and looking for potential for growth.
We can put that as
- for any list of duties/requirements/benefits. So we need to convert responsibilities into list items. We must not lose any detail. So we need to split the responsibilities into distinct items. Let's parse the responsibilities text:
"Regulatory representation and leadership to cross-functional products teams, development of regulatory strategies and support PROCEPT’s products, marketing applications and post-market activitiesProviding training, coaching and mentoring to other regulatory affairs specialistsAssisting in strategic decision making, and representing regulatory at all levels of the businessResponsible for project timelines and management of regulatory submissions including preparing IDE, 510K and international submissions for new products, new indications, and significant product changes, to ensure compliance with the FDA and international regulations and guidelinesPrepare Letters to File documentation to support internal filings for product development projects and product changes not requiring regulatory agency approvalsPrepare and maintain Technical Files/Technical Documentation for Europe (CE Mark) for new products, new indications, and significant product changesSupport product development teams on regulatory issues, including review of documentationProvide regulatory assessments for anticipated design, manufacturing, and labeling changesRepresent RA functional area in the review and approval of Engineering Change Orders (ECO)Provide regulatory guidance with regard to the preparation, review and approval of labeling and promotional materialsPerform regulatory research and stay abreast of changes for US and international regulations and requirementsProvide regulatory support for quality assurance and regulatory compliance activities as requiredMaintain well-organized, auditable regulatory filesMaintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory complianceUnderstand and adhere to the PROCEPT BioRobotics EHS Policy"
We need to split at each capitalized verb start? Let's identify items:
1. Regulatory representation and leadership to cross-functional products teams, development of regulatory strategies and support PROCEPT’s products, marketing applications and post-market activities
2. Providing training, coaching and mentoring to other regulatory affairs specialists
3. Assisting in strategic decision making, and representing regulatory at all levels of the business
4. Responsible for project timelines and management of regulatory submissions including preparing IDE, 510K and international submissions for new products, new indications, and significant product changes, to ensure compliance with the FDA and international regulations and guidelines
5. Prepare Letters to File documentation to support internal filings for product development projects and product changes not requiring regulatory agency approvals
6. Prepare and maintain Technical Files/Technical Documentation for Europe (CE Mark) for new products, new indications, and significant product changes
7. Support product development teams on regulatory issues, including review of documentation
8. Provide regulatory assessments for anticipated design, manufacturing, and labeling changes
9. Represent RA functional area in the review and approval of Engineering Change Orders (ECO)
10. Provide regulatory guidance with regard to the preparation, review and approval of labeling and promotional materials
11. Perform regulatory research and stay abreast of changes for US and international regulations and requirements
12. Provide regulatory support for quality assurance and regulatory compliance activities as required
13. Maintain well-organized, auditable regulatory files
14. Maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance
15. Understand and adhere to the PROCEPT BioRobotics EHS Policy
That seems comprehensive.
Now qualifications list: The text after "Qualifications / Skills Required" includes:
- Bachelor’s degree in a scientific discipline; advanced degree and RAC (Regulatory Affairs Certificate) preferred
- Minimum of 12 years’ experience in medical device industry with experience in regulatory affairs with direct submissions responsibilities
- Knowledge of relevant Title 21 of the US code of Federal Regulations is required
- Experience with US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k) is required
- Experience with European Medical Device Directive (93/42/EEC with 2007/47/EC) is required
- Experience with Quality Management System Standard ISO 13485 is required
- Experience with Risk Management Standard ISO 14971 is required
- Knowledge of EU MDR regulations is required
- Knowledge of International Medical Device requirements (Canada, Australia, New Zealand, China, Japan, etc.) is preferred
- Proficiency in basic computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat
- Strong organization skills, able to manage multiple projects and timelines
- Competence in applying scientific principles and logical thought processes in preparing regulatory documentation
- Excellent oral and written communication skills
- Strong attention to detail
- Ability to work independently as an individual contributor and in a team environment
- Knowledge of software development and software quality as it relates to regulatory submissions a plus
We need to output as
- .
We need to preserve all substantive information; do not invent or summarize away detail. So we need to include each responsibility sentence as separate list item? The responsibilities are a long paragraph with many items separated by spaces but we can split by verbs? Better to keep as one paragraph? But rule says use
- each item. Qualifications list also