RA Director NA, Compliance & Strategic Programs
for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. Must not repeat job title as heading. Must not include Job ID etc. Remove boilerplate like EEO, legal, scam warning, etc. Must preserve all substantive info.
We need to parse the posting.
Content:
- Intro paragraph about Diasorin (company description). Could be "About the role"? Actually "About the role" maybe not present. The posting includes "Why Join Diasorin" with bullet points: Build What Matters, Innovate with Agility at a Global Scale, Grow in a People-Centered Culture. That could be "About the role" or maybe "Why Join Diasorin". But headings allowed: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We can map sections accordingly.
We have:
- Job Scope description: "The RA Director NA, Compliance & Strategic Programs will be responsible for directing Regulatory related activities..." That's responsibilities.
- Duties and Responsibilities: bullet list (though not bullet but colon separated). We'll need to convert to - .
- Education, Experience And Qualifications: list of qualifications.
- Training And Skills: list of skills.
- Other Requirements: bullet list.
- Benefits: paragraph about Diasorin offers a competitive rewards package... Benefits may vary... Also mention annual incentive program.
- Pay: Not mentioned explicitly. No salary info. So we should NOT include Pay section.
- Schedule: Not mentioned. So no Schedule.
- About the role: maybe we can include the introductory paragraph about Diasorin and the "Why Join Diasorin" section as "About the role". Or we could treat "Why Join Diasorin" as "About the role". The instruction: use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can include About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits. Possibly also "Other Requirements" could be part of Requirements or Qualifications. But we need to follow headings list; we can't add custom headings like "Other Requirements". We could incorporate into Requirements or Qualifications.
We need to preserve all substantive info. So we need to include everything except boilerplate.
Let's extract substantive sections:
1. Company description / Why Join Diasorin: "Obsessed by Science. Entrepreneurial by Nature. United by Purpose. Diasorin is a global leader..." plus "Why Join Diasorin Build What Matters Take ownership, challenge the status quo, and contribute directly to solutions that improve patient care worldwide.Innovate with Agility at a Global Scale Work in an entrepreneurial environment that enables speed, collaboration, and global impact.Grow in a People-Centered Culture Thrive in a culture that values accountability, inclusion, and continuous development."
We can combine into a paragraph(s) under About the role.
2. Job Scope: description of responsibilities.
3. Duties and Responsibilities: list.
We could merge Job Scope and Duties and Responsibilities into Responsibilities section.
4. Education, Experience And Qualifications: qualifications.
5. Training And Skills: skills.
6. Other Requirements: maybe part of Requirements or Qualifications.
7. Benefits: paragraph.
We must not include EEO, legal, fraud notice, etc.
Let's craft HTML.
Structure:
About the role
Obsessed by Science. Entrepreneurial by Nature. United by Purpose. Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide. For more than 50 years, we have combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions. As the Diagnostics Specialist, Diasorin continuously invests in research, technology, and people. Guided by our values of operational excellence, customer focus, and teamwork, we empower teams to think boldly, act decisively, and transform ideas into meaningful impact across one of the industry’s broadest specialty diagnostic portfolios. When you join Diasorin, you are not just filling a role. You are helping build what comes next. Why Join Diasorin Build What Matters Take ownership, challenge the status quo, and contribute directly to solutions that improve patient care worldwide.Innovate with Agility at a Global Scale Work in an entrepreneurial environment that enables speed, collaboration, and global impact.Grow in a People-Centered Culture Thrive in a culture that values accountability, inclusion, and continuous development.
But note: The "Why Join Diasorin" sentences are concatenated without spaces. We need to preserve as is? The original text: "Why Join Diasorin Build What Matters Take ownership, challenge the status quo, and contribute directly to solutions that improve patient care worldwide.Innovate with Agility at a Global Scale Work in an entrepreneurial environment that enables speed, collaboration, and global impact.Grow in a People-Centered Culture Thrive in a culture that values accountability, inclusion, and continuous development." It seems missing spaces after periods. We should keep exactly as given? Probably we should preserve the text but we can add spaces for readability? The instruction: Preserve ALL substantive information; do NOT invent or summarize away detail. Adding spaces could be considered altering. Better to keep as is, but it's awkward. However we could keep line breaks to separate. The original had line breaks? In the posting, it's likely each bullet on new line but got merged. We'll keep as is but maybe add
to separate? That would be adding markup not present. Safer to keep the exact string.
Thus we keep the string exactly as given.
Now Responsibilities:
We need to combine Job Scope and Duties and Responsibilities.
Job Scope paragraph: "The RA Director NA, Compliance & Strategic Programs will be responsible for directing Regulatory related activities for software/hardware of DiaSorin immuno and molecular units such as: Identifying new regulatory requirements and giving guidance for the local implementation ensuring the application of pertinent DiaSorin regulatory procedures Ensuring regulatory compliance of strategic projects Ensuring compliance with various regulation requirements and/or programs such as FDA, Health Canada and state agencies. Interacts with regulatory agencies and ensures compliance with all applicable regulations including ISO, Local, State, and Federal requirements, where applicable. This leadership role will ensure full support in identifying regulatory strategies to be aligned with company goals and the evolving regulatory environment in the healthcare industry. The Director SD&I Compliance & Strategic Projects Regulatory Affairs, North America will also collaborate with key cross-functional teams including R&D, Legal, Marketing, Clinical Affairs, and Operations to assure RA Compliance in submission process for North American market, including the United States and Canada."
Then Duties and Responsibilities list:
- Cross Functional cooperation on Key projects:Support RA team in develop and implement regulatory strategies for the products in North America, ensuring timely market access for all new products and continued compliance for existing products.
- Support the team, fostering a high-performance culture and a deep understanding of regulatory requirements and industry standards.
- Identifying potential risks and opportunities, and ensuring alignment with global corporate objectives.
- Stay abreast of industry trends and regulatory changes impacting product approval processes, quality standards, and market access requirements in the U.S. and Canada.
- Regulatory Compliance and Approvals:In conjunction with RA team assure Compliance in submissions and approvals for new Immuno and Molecular Diagnostics products with the FDA, Health Canada, and other relevant regulatory bodies.
- Review regulatory filings, including pre Submissions, 510(k) premarket notifications, PMA (Premarket Approval) applications, and other relevant filings as required by regulatory authorities.
- Partner with RA team in the preparation and submission of regulatory documents, ensuring that all submissions meet regulatory requirements and are completed on time.
- Establish and maintain relationships with key regulatory agencies to facilitate approval processes and support post-market surveillance.
- Partner with the R&D, Quality Assurance, Clinical Affairs, and Operations teams to ensure regulatory requirements are fully understood and integrated into product development processes.
- Risk Management and Issue Resolution:Support risk management efforts related to regulatory compliance, ensuring that product-related issues are identified early, mitigated, and resolved in a timely manner.
- Address regulatory challenges, providing solutions to support business continuity, and managing any regulatory hurdles that may arise during product lifecycle management.
We need to format as - each item. The items currently have colons and no spaces after colon. We'll keep as is.
Now Requirements/Qualifications:
Education, Experience And Qualifications:
- Advanced degree (MS, PhD, or equivalent) in Life Sciences, Medical Device, or Regulatory Affairs.
- Certification in Regulatory Affairs (e.g., RAC) is a plus.
- Minimum of 5 years of experience in regulatory affairs.
- Proven experience in successfully managing regulatory submissions for Immuno and Molecular Diagnostics products, including FDA 510(k), PMA, and Health Canada submissions.
- In-depth knowledge of the regulatory landscape in North America.
Training And Skills:
- Excellent communication and interpersonal skills, with the ability to influence and collaborate across cross-functional teams and with senior leadership.
- High level of technical knowledge in regulatory submissions, risk management, and product lifecycle management.
- Strong analytical and problem-solving abilities, with a keen eye for detail and a proactive approach to managing regulatory challenges.
Other Requirements:
- Ability to travel as required for business needs.
- Strong proficiency in regulatory compliance tools, document management systems, and project management software.
- Demonstrated ability to drive results in a fast-paced, high-growth environment.
We could combine Education, Experience And Qualifications and Training And Skills into Requirements and Qualifications sections? The headings list includes Requirements, Qualifications, Skills. We could map:
- Requirements: Education, Experience And Qualifications + Other Requirements? Or separate.
- Qualifications: maybe same as Requirements? But we need to avoid duplication.
Better to follow typical pattern: Requirements (education/experience), Qualifications (certifications etc), Skills (technical/soft). But we have overlapping.
Given instruction: Prefer a few substantive sections over many thin ones. So we could combine into Requirements (education/experience), Qualifications (certifications etc), Skills (soft/technical). Other Requirements could go into Requirements.
Let's decide:
Requirements
Advanced degree (MS, PhD, or equivalent) in Life Sciences, Medical Device, or Regulatory Affairs. Certification in Regulatory Affairs (e.g., RAC) is a plus. Minimum of 5 years of experience in regulatory affairs. Proven experience in successfully managing regulatory submissions for Immuno and Molecular Diagnostics products, including FDA 510(k), PMA, and Health Canada submissions. In-depth knowledge of the regulatory landscape in North America. Ability to travel as required for business needs. Strong proficiency in regulatory compliance tools, document management systems, and project management software. Demonstrated ability to drive results in a fast-paced, high-growth environment.
Qualifications
Maybe we could put nothing? But we need to avoid empty sections. We could skip Qualifications if no distinct content. However we have certification mention already in Requirements. Could move certification to Qualifications. Let's separate:
Requirements: education/experience.
Qualifications: certification.
Skills: communication, technical knowledge, analytical, problem-solving.
Other Requirements (travel, tools, drive results) could go under Requirements as well.
Let's structure:
- Requirements: education/experience + ability to travel + proficiency in tools + ability to drive results.
- Qualifications: Certification in Regulatory Affairs (e.g., RAC) is a plus.
- Skills: Excellent communication and interpersonal skills, with the ability to influence and collaborate across cross-functional teams and with senior leadership. High level of technical knowledge in regulatory submissions, risk management, and product lifecycle management. Strong analytical and problem-solving abilities, with a keen eye for detail and a proactive approach to managing regulatory challenges.
That seems reasonable.
Now Benefits:
Paragraph: "Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can include About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits. Possibly also "Other Requirements" could be part of Requirements or Qualifications. But we need to follow headings list; we can't add custom headings like "Other Requirements". We could incorporate into Requirements or Qualifications.
We need to preserve all substantive info. So we need to include everything except boilerplate.
Let's extract substantive sections:
1. Company description / Why Join Diasorin: "Obsessed by Science. Entrepreneurial by Nature. United by Purpose. Diasorin is a global leader..." plus "Why Join Diasorin Build What Matters Take ownership, challenge the status quo, and contribute directly to solutions that improve patient care worldwide.Innovate with Agility at a Global Scale Work in an entrepreneurial environment that enables speed, collaboration, and global impact.Grow in a People-Centered Culture Thrive in a culture that values accountability, inclusion, and continuous development."
We can combine into a paragraph(s) under About the role.
2. Job Scope: description of responsibilities.
3. Duties and Responsibilities: list.
We could merge Job Scope and Duties and Responsibilities into Responsibilities section.
4. Education, Experience And Qualifications: qualifications.
5. Training And Skills: skills.
6. Other Requirements: maybe part of Requirements or Qualifications.
7. Benefits: paragraph.
We must not include EEO, legal, fraud notice, etc.
Let's craft HTML.
Structure:
About the role
Obsessed by Science. Entrepreneurial by Nature. United by Purpose. Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide. For more than 50 years, we have combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions. As the Diagnostics Specialist, Diasorin continuously invests in research, technology, and people. Guided by our values of operational excellence, customer focus, and teamwork, we empower teams to think boldly, act decisively, and transform ideas into meaningful impact across one of the industry’s broadest specialty diagnostic portfolios. When you join Diasorin, you are not just filling a role. You are helping build what comes next. Why Join Diasorin Build What Matters Take ownership, challenge the status quo, and contribute directly to solutions that improve patient care worldwide.Innovate with Agility at a Global Scale Work in an entrepreneurial environment that enables speed, collaboration, and global impact.Grow in a People-Centered Culture Thrive in a culture that values accountability, inclusion, and continuous development.
But note: The "Why Join Diasorin" sentences are concatenated without spaces. We need to preserve as is? The original text: "Why Join Diasorin Build What Matters Take ownership, challenge the status quo, and contribute directly to solutions that improve patient care worldwide.Innovate with Agility at a Global Scale Work in an entrepreneurial environment that enables speed, collaboration, and global impact.Grow in a People-Centered Culture Thrive in a culture that values accountability, inclusion, and continuous development." It seems missing spaces after periods. We should keep exactly as given? Probably we should preserve the text but we can add spaces for readability? The instruction: Preserve ALL substantive information; do NOT invent or summarize away detail. Adding spaces could be considered altering. Better to keep as is, but it's awkward. However we could keep line breaks to separate. The original had line breaks? In the posting, it's likely each bullet on new line but got merged. We'll keep as is but maybe addto separate? That would be adding markup not present. Safer to keep the exact string. Thus we keep the string exactly as given. Now Responsibilities: We need to combine Job Scope and Duties and Responsibilities. Job Scope paragraph: "The RA Director NA, Compliance & Strategic Programs will be responsible for directing Regulatory related activities for software/hardware of DiaSorin immuno and molecular units such as: Identifying new regulatory requirements and giving guidance for the local implementation ensuring the application of pertinent DiaSorin regulatory procedures Ensuring regulatory compliance of strategic projects Ensuring compliance with various regulation requirements and/or programs such as FDA, Health Canada and state agencies. Interacts with regulatory agencies and ensures compliance with all applicable regulations including ISO, Local, State, and Federal requirements, where applicable. This leadership role will ensure full support in identifying regulatory strategies to be aligned with company goals and the evolving regulatory environment in the healthcare industry. The Director SD&I Compliance & Strategic Projects Regulatory Affairs, North America will also collaborate with key cross-functional teams including R&D, Legal, Marketing, Clinical Affairs, and Operations to assure RA Compliance in submission process for North American market, including the United States and Canada." Then Duties and Responsibilities list: - Cross Functional cooperation on Key projects:Support RA team in develop and implement regulatory strategies for the products in North America, ensuring timely market access for all new products and continued compliance for existing products. - Support the team, fostering a high-performance culture and a deep understanding of regulatory requirements and industry standards. - Identifying potential risks and opportunities, and ensuring alignment with global corporate objectives. - Stay abreast of industry trends and regulatory changes impacting product approval processes, quality standards, and market access requirements in the U.S. and Canada. - Regulatory Compliance and Approvals:In conjunction with RA team assure Compliance in submissions and approvals for new Immuno and Molecular Diagnostics products with the FDA, Health Canada, and other relevant regulatory bodies. - Review regulatory filings, including pre Submissions, 510(k) premarket notifications, PMA (Premarket Approval) applications, and other relevant filings as required by regulatory authorities. - Partner with RA team in the preparation and submission of regulatory documents, ensuring that all submissions meet regulatory requirements and are completed on time. - Establish and maintain relationships with key regulatory agencies to facilitate approval processes and support post-market surveillance. - Partner with the R&D, Quality Assurance, Clinical Affairs, and Operations teams to ensure regulatory requirements are fully understood and integrated into product development processes. - Risk Management and Issue Resolution:Support risk management efforts related to regulatory compliance, ensuring that product-related issues are identified early, mitigated, and resolved in a timely manner. - Address regulatory challenges, providing solutions to support business continuity, and managing any regulatory hurdles that may arise during product lifecycle management. We need to format as
- each item. The items currently have colons and no spaces after colon. We'll keep as is.
Now Requirements/Qualifications:
Education, Experience And Qualifications:
- Advanced degree (MS, PhD, or equivalent) in Life Sciences, Medical Device, or Regulatory Affairs.
- Certification in Regulatory Affairs (e.g., RAC) is a plus.
- Minimum of 5 years of experience in regulatory affairs.
- Proven experience in successfully managing regulatory submissions for Immuno and Molecular Diagnostics products, including FDA 510(k), PMA, and Health Canada submissions.
- In-depth knowledge of the regulatory landscape in North America.
Training And Skills:
- Excellent communication and interpersonal skills, with the ability to influence and collaborate across cross-functional teams and with senior leadership.
- High level of technical knowledge in regulatory submissions, risk management, and product lifecycle management.
- Strong analytical and problem-solving abilities, with a keen eye for detail and a proactive approach to managing regulatory challenges.
Other Requirements:
- Ability to travel as required for business needs.
- Strong proficiency in regulatory compliance tools, document management systems, and project management software.
- Demonstrated ability to drive results in a fast-paced, high-growth environment.
We could combine Education, Experience And Qualifications and Training And Skills into Requirements and Qualifications sections? The headings list includes Requirements, Qualifications, Skills. We could map:
- Requirements: Education, Experience And Qualifications + Other Requirements? Or separate.
- Qualifications: maybe same as Requirements? But we need to avoid duplication.
Better to follow typical pattern: Requirements (education/experience), Qualifications (certifications etc), Skills (technical/soft). But we have overlapping.
Given instruction: Prefer a few substantive sections over many thin ones. So we could combine into Requirements (education/experience), Qualifications (certifications etc), Skills (soft/technical). Other Requirements could go into Requirements.
Let's decide:
Requirements
Advanced degree (MS, PhD, or equivalent) in Life Sciences, Medical Device, or Regulatory Affairs. Certification in Regulatory Affairs (e.g., RAC) is a plus. Minimum of 5 years of experience in regulatory affairs. Proven experience in successfully managing regulatory submissions for Immuno and Molecular Diagnostics products, including FDA 510(k), PMA, and Health Canada submissions. In-depth knowledge of the regulatory landscape in North America. Ability to travel as required for business needs. Strong proficiency in regulatory compliance tools, document management systems, and project management software. Demonstrated ability to drive results in a fast-paced, high-growth environment.
Qualifications
Maybe we could put nothing? But we need to avoid empty sections. We could skip Qualifications if no distinct content. However we have certification mention already in Requirements. Could move certification to Qualifications. Let's separate: Requirements: education/experience. Qualifications: certification. Skills: communication, technical knowledge, analytical, problem-solving. Other Requirements (travel, tools, drive results) could go under Requirements as well. Let's structure: - Requirements: education/experience + ability to travel + proficiency in tools + ability to drive results. - Qualifications: Certification in Regulatory Affairs (e.g., RAC) is a plus. - Skills: Excellent communication and interpersonal skills, with the ability to influence and collaborate across cross-functional teams and with senior leadership. High level of technical knowledge in regulatory submissions, risk management, and product lifecycle management. Strong analytical and problem-solving abilities, with a keen eye for detail and a proactive approach to managing regulatory challenges. That seems reasonable. Now Benefits: Paragraph: "Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks