INGENYX- Regulatory Affairs Coordinator
for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must include sections only if posting has real specific content. We have content: About the role? There's a paragraph about Ingenyx and joining dynamic team. Could be "About the role" or maybe "About Ingenyx". The instruction: use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can create sections: About the role (maybe summarizing company description and position summary). Responsibilities (list of principal responsibilities). Requirements (Education/Experience). Skills (Specialized Skills/Other Requirements). Benefits (benefits described). Pay (pay range). Schedule? Not present. Travel? Expected Travel: Up to 10% - maybe could be under Schedule? But schedule is about work hours; travel is separate. Not required to include Schedule if no content. We'll not include Schedule.
We must not repeat job title as heading. No Job ID/requisition numbers as headings; we can fold minor metadata into short
or drop it. We have Expected Travel: Up to 10% and Requisition ID: 14464. We can include travel in a
maybe under About the role or separate small paragraph. Probably include as a short
after About the role. We must preserve all substantive information; do not invent or summarize away detail. So we need to include all details from posting: company description, position summary, responsibilities bullet points, education/experience requirements, specialized skills, benefits, pay range, travel expectation, maybe also note about at-will employment, hiring process, EEO, accommodation contact? Those are boilerplate/legal/EEO etc. We must remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. So we should remove equal opportunity employer statement, accommodation contact, unsolicited resumes note, etc. Also remove "If hired, employee will be in an “at-will position”..." maybe that's legal boilerplate; but it's substantive? It's about employment terms. Might be considered boilerplate? The instruction: remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate. The at-will statement is legal; likely remove. Also "Details of participation in these benefit plans will be provided if an employee receives an offer of employment." That's part of benefits description; we can keep benefits but maybe drop that sentence as it's generic. However we need to preserve ALL substantive information; not sure if that is substantive. It's more procedural. Might be okay to keep but it's not specific detail. Safer to keep benefits description but maybe drop that sentence. The instruction: "Preserve ALL substantive information; do NOT invent or summarize away detail." So we should keep details like benefits list: medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, various paid time off benefits such as PTO, short- and long-term disability and parental leave. Keep that. Pay range: keep. Travel: Expected Travel: Up to 10% - keep. We need to output only HTML fragment, no /, no markdown fences. Let's structure:
About the role
Ingenyx proudly launched as a new, independent company following its divestiture from Teleflex on August 3, 2026. Ingenyx is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives. For more information, please visit Ingenyx.com
Expected Travel: Up to 10%
Then Position Summary maybe part of About the role? Could be separatePosition Summary
but not in allowed headings list. The allowed headings are those examples; we could still use other headings? The instruction: "use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It suggests we should use those headings; but we could also use other headings if needed? Probably better to stick to those. Position Summary could be merged into About the role or Responsibilities. We have a Position Summary paragraph: "The Regulatory Affairs Coordinator supports the Quality and Regulatory Affairs organization through regulatory intelligence, standards management, regulatory change coordination, regulatory authority interactions, and U.S. import regulatory compliance. This role serves as the central coordinator for regulatory and standards information and as a key resource for FDA and U.S. Customs and Border Protection (CBP) import requirements, including FDA Automated Commercial Environment (ACE) activities." That's substantive; we could put it under About the role as a paragraph.
Then Responsibilities: list of principal responsibilities bullet points.
We need to use - for any list of duties/requirements/benefits.
So Responsibilities:
- ...
...
We need to preserve all bullet points.
Let's extract responsibilities:
- Regulatory Intelligence & Standards Management
* Support ongoing QARA intelligence activities by monitoring new and changing regulations, standards, and regulatory guidance by maintaining the organization's Standards e-system, standards watchlists, and applicable standards inventory.
* Maintain regulatory intelligence records, trackers, and supporting documentation.
- Regulatory Change Notification
* Coordinate the Regulatory Change Notification process for changes potentially affecting registrations, licenses, certifications, technical documentation, labeling, or regulatory commitments.
* Maintain regulatory correspondence and supporting records.
- FDA ACE & CBP Import Compliance
* Serve as the QARA subject matter resource for FDA Automated Commercial Environment (ACE) and FDA/CBP medical device import requirements.
* Coordinate and maintain FDA ACE data required for imported finished goods, components, raw materials, and other regulated articles.
* Support creation, review, and maintenance of FDA-related master data in business systems such as SAP ECC6, SAP MDG, or other applicable enterprise systems, including establishment names and addresses, manufacturer/exporter information, importer-of-record details, FDA product codes, device listing references, and regulatory identifiers.
* Partner with Trade Compliance, Supply Chain, Logistics, Customs Brokers, and Regulatory Affairs to support compliant importation of regulated products and materials.
* Support resolution of FDA/CBP import-entry issues, to include coordination of responses to FDA Notices of Action, entry holds, detentions, requests for documents, or other FDA/CBP import-entry inquiries in partnership with Trade Compliance, customs brokers, and appropriate internal SMEs.
* Monitor changes to FDA/CBP import requirements and coordinate assessment and implementation of applicable changes.
- Notified Body & Regulatory Authority Coordination
* Serve as an administrative point of contact for Notified Bodies and regulatory authorities, under the direction of Regulatory Affairs leadership.
* Track regulatory commitments, requests for information, audit actions, and required responses.
* Support regulatory inspections, assessments, and Notified Body audits.
- Regulatory Operations
* Maintain regulatory trackers, databases, certificates, licenses, registrations, and related documentation.
* Support preparation, compilation, formatting, and administrative processing of regulatory submissions and notifications.
* Prepare routine regulatory status reports and metrics.
We need to keep each bullet as - . Could combine sub-bullets? The instruction: use
- for any list of duties/requirements/benefits. It doesn't forbid nested lists, but we can keep flat list with each duty as separate
- . Might be lengthy but okay.
Now Requirements: Education / Experience Requirements paragraph.
We need to capture:
Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, Quality, Supply Chain, Business, or related discipline preferred.
3–5 years of experience in Regulatory Affairs, Regulatory Operations, Quality, Trade Compliance, or a related medical device environment.
Experience with FDA ACE requirements and medical device importation strongly preferred.
Working knowledge of FDA medical device establishment registration, device listing, product codes, and import-entry requirements.
Familiarity with U.S. Customs and Border Protection (CBP) processes and working with customs brokers.
Familiarity with ISO 13485, FDA medical device requirements, and EU MDR.
Experience with regulatory intelligence or standards-management systems preferred.
Strong organizational, analytical, and project-coordination skills.
Strong attention to detail and ability to manage multiple regulatory deadlines.
Effective written and verbal communication skills.
We can put as
- each.
Skills: Specialized Skills / Other Requirements bullet list:
- Regulatory intelligence and standards monitoring
- Regulatory change coordination
- FDA ACE and medical device import compliance
- FDA/CBP regulatory requirements
- Regulatory authority and Notified Body coordination
We can put as
- .
Benefits: The total compensation package includes benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered.
We can make a
- list.
Pay: The pay range for this position at commencement of employment is expected to be between $65,700- $85,000, however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.
We can put as
.
Now we need to avoid duplicating lines. Ensure we don't repeat.
Now produce HTML.
Let's craft:
About the role
Ingenyx proudly launched as a new, independent company following its divestiture from Teleflex on August 3, 2026. Ingenyx is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives. For more information, please visit Ingenyx.com
The Regulatory Affairs Coordinator supports the Quality and Regulatory Affairs organization through regulatory intelligence, standards management, regulatory change coordination, regulatory authority interactions, and U.S. import regulatory compliance. This role serves as the central coordinator for regulatory and standards information and as a key resource for FDA and U.S. Customs and Border Protection (CBP) import requirements, including FDA Automated Commercial Environment (ACE) activities.
Expected Travel: Up to 10%
Responsibilities
- Support ongoing Quality and Regulatory Affairs (QARA) intelligence activities by monitoring new and changing regulations, standards, and regulatory guidance by maintaining the organization's Standards e-system, standards watchlists, and applicable standards inventory.
- Maintain regulatory intelligence records, trackers, and supporting documentation.
- Coordinate the Regulatory Change Notification process for changes potentially affecting registrations, licenses, certifications, technical documentation,
- ... ...
- for any list of duties/requirements/benefits. It doesn't forbid nested lists, but we can keep flat list with each duty as separate
- . Might be lengthy but okay.
Now Requirements: Education / Experience Requirements paragraph.
We need to capture:
Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, Quality, Supply Chain, Business, or related discipline preferred.
3–5 years of experience in Regulatory Affairs, Regulatory Operations, Quality, Trade Compliance, or a related medical device environment.
Experience with FDA ACE requirements and medical device importation strongly preferred.
Working knowledge of FDA medical device establishment registration, device listing, product codes, and import-entry requirements.
Familiarity with U.S. Customs and Border Protection (CBP) processes and working with customs brokers.
Familiarity with ISO 13485, FDA medical device requirements, and EU MDR.
Experience with regulatory intelligence or standards-management systems preferred.
Strong organizational, analytical, and project-coordination skills.
Strong attention to detail and ability to manage multiple regulatory deadlines.
Effective written and verbal communication skills.
We can put as
- each.
Skills: Specialized Skills / Other Requirements bullet list:
- Regulatory intelligence and standards monitoring
- Regulatory change coordination
- FDA ACE and medical device import compliance
- FDA/CBP regulatory requirements
- Regulatory authority and Notified Body coordination
We can put as
- .
Benefits: The total compensation package includes benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered.
We can make a
- list.
Pay: The pay range for this position at commencement of employment is expected to be between $65,700- $85,000, however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.
We can put as
. Now we need to avoid duplicating lines. Ensure we don't repeat. Now produce HTML. Let's craft:
About the role
Ingenyx proudly launched as a new, independent company following its divestiture from Teleflex on August 3, 2026. Ingenyx is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives. For more information, please visit Ingenyx.com
The Regulatory Affairs Coordinator supports the Quality and Regulatory Affairs organization through regulatory intelligence, standards management, regulatory change coordination, regulatory authority interactions, and U.S. import regulatory compliance. This role serves as the central coordinator for regulatory and standards information and as a key resource for FDA and U.S. Customs and Border Protection (CBP) import requirements, including FDA Automated Commercial Environment (ACE) activities.
Expected Travel: Up to 10%
Responsibilities
- Support ongoing Quality and Regulatory Affairs (QARA) intelligence activities by monitoring new and changing regulations, standards, and regulatory guidance by maintaining the organization's Standards e-system, standards watchlists, and applicable standards inventory.
- Maintain regulatory intelligence records, trackers, and supporting documentation.
- Coordinate the Regulatory Change Notification process for changes potentially affecting registrations, licenses, certifications, technical documentation,
- list.
Pay: The pay range for this position at commencement of employment is expected to be between $65,700- $85,000, however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.
We can put as
- .
Benefits: The total compensation package includes benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered.
We can make a
- each.
Skills: Specialized Skills / Other Requirements bullet list:
- Regulatory intelligence and standards monitoring
- Regulatory change coordination
- FDA ACE and medical device import compliance
- FDA/CBP regulatory requirements
- Regulatory authority and Notified Body coordination
We can put as