Principal Regulatory Affairs Specialist

Preferred Qualificationsnice to have

• Experience preparing a variety of regulatory submissions, including PMAs and 510(k)s for implantable or active implantable medical devices.
• Demonstrated knowledge of regulations applicable to the conduct of clinical trials.
• Demonstrated experience collaborating within a cross-functional team environment.
• Ability to manage multiple projects simultaneously.
• Strong research and analytical skills.
• Experience mentoring regulatory professionals or leading regulatory workstreams without direct supervisory authority.
• Strong interpersonal and influencing skills.
• Proficiency with Microsoft Word, Excel and PowerPoint.

• People – Our first responsibility is to the patients we serve.
• Integrity – Do the right thing
• Pioneering – Lead Boldly, Change Lives, Disrupt the Status-Quo
• Performance – Win together – Deliver with Excellence.

1. 1Provide guidance to cross-functional partners and junior regulatory affairs staff.
2. 2Monitor new and changing regulations, assess business impact, and recommend appropriate actions.
3. 3Review device labeling, advertising, and promotional materials for compliance with approved submissions and applicable global regulations.
4. 4Maintain complete and current regulatory files, product registrations, and supporting documentation.
5. 5Prepare for and support communications with regulatory agencies and Notified Bodies regarding pre-submission strategy, regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
6. 6Act as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications.
7. 7Develop and implement regulatory strategies for new and modified products.
8. 8Act as the Regulatory Affairs lead on product integration workstreams, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle while coordinating team inputs for regulatory submissions.
9. 9Review and approve design and manufacturing changes, ensuring compliance with applicable regulations.
10. 10Prepare and submit global regulatory applications.
11. 11Support highly technical product lines, including product integrations, sterilization processes and other special projects or strategic initiatives.
12. 12Participate actively in regulatory collaborations and alignment with other regulatory specialists supporting product integration efforts.

1. 13Bachelor's degree in a scientific or technical discipline.
2. 14Minimum of 7 years' experience in Regulatory Affairs within the medical device industry.
3. 15Demonstrated experience with regulatory requirements for implantable or active implantable medical devices.
4. 16Demonstrated experience supporting product development and sustaining activities for implantable or active implantable medical devices.
5. 17Experience preparing regulatory submissions for medical devices.
6. 18Demonstrated experience working within a product development process and design controls.
7. 19Strong understanding of FDA regulations, EU MDR, international regulatory frameworks, product lifecycle requirements, labeling review, and regulatory compliance practices.
8. 20Experience leading FDA meetings, agency interactions, audits, inspections, and cross-functional regulatory strategy discussions.
9. 21Excellent written and verbal communication, technical writing and editing skills.