Regulatory Affairs Manager

Freudenberg; United States; Remote; USD 80,000 - 120,000; Full time

Job summary

Join a forward-thinking organization that prioritizes regulatory excellence in the medical device industry. In this pivotal role, you will guide cross-functional teams, oversee regulatory submissions, and ensure compliance with global standards. Your expertise will be crucial in navigating complex regulatory landscapes and securing approvals from bodies such as the FDA and Health Canada. This dynamic position offers the opportunity to drive impactful projects while fostering a culture of compliance and excellence. If you are passionate about regulatory affairs and eager to make a difference in a collaborative environment, this role is for you.

Qualifications

• 8+ years of regulatory experience with medical devices.
• Strong knowledge of FDA regulations and ISO quality systems.

Responsibilities

• Guide regulatory decision making and oversee submissions.
• Lead the Regulatory Affairs team and ensure compliance.

Skills

Regulatory Affairs

FDA Submissions

MDR Compliance

Leadership

Communication Skills

Education

BS in Regulatory Sciences

Job description

Working at Freudenberg: We will wow your world!

Responsibilities:

1. Provide regulatory excellence to the organization and guide decision making in cross-functional settings as a player/coach.
2. Create and oversee regulatory plans and submissions, including documents for FDA, Health Canada, MDR Notified Bodies, and ROW countries, to secure approvals (e.g., 510(k), EU Technical Files).
3. Direct, coordinate, and supervise activities of the Regulatory Affairs team. Establish project priorities and ensure resource availability.
4. Lead regulatory aspects for cross-functional project teams (new product development, manufacturing, etc.), providing input and guidance.
5. Maintain company registration and device listings for global regulatory bodies (e.g., FDA Establishment Registration, Device Listings, Certificates).
6. Complete international product registrations and provide regulatory information to distributors.
7. Review and approve product labeling, marketing, and advertising copy from a regulatory standpoint.
8. Assess, provide input, and approve regulatory aspects of product development and design control projects.
9. Ensure awareness and proper referencing of relevant medical device standards, regulations, and directives; provide interpretive assistance for filings.
10. Handle regulatory reporting, including FDA MDR, CMDR, EU Vigilance, and communicate recall actions to agencies and distributors.
11. Organize and complete domestic and international recall issues, communicating actions to relevant parties.
12. Work with management to ensure compliance with all applicable regulations and conduct audits as required.
13. This position serves as the Freudenberg Medical "Person Responsible for Regulatory Compliance" (PRRC) per EU MDR 2017/745, Art. 15, including responsibilities related to technical documentation, post-market surveillance, and reporting obligations.
14. Review and perform impact assessments for manufacturing and product changes; communicate with regulatory bodies.
15. Conduct training programs on regulatory processes and requirements for employees.
16. Communicate with regulatory authorities for clarification and follow-up on submissions.
17. Assess product, manufacturing, and labeling changes for regulatory reporting; review marketing and sales materials for compliance.
18. Serve as the regulatory liaison/representative during internal and external audits.

Qualifications:

1. BS degree (preferably in Regulatory Sciences/Practices) or equivalent with RA coursework/seminars.
2. Minimum of 8 years regulatory experience with medical devices, with successful FDA and MDR submissions.
3. Experience preparing and defending regulatory submissions to FDA (510(k), Qsubs, IDEs, MDR files).
4. Proven success in dealings with Notified Bodies, Competent Authorities, and Authorized Representatives.
5. Willingness to travel to Carpinteria, CA, as needed.
6. Strong knowledge of global regulatory requirements, FDA regulations, ISO quality systems, and CE standards.
7. Managerial experience supervising teams; strong leadership skills.
8. Ability to perform in a dynamic environment, prioritize tasks, and communicate effectively.
9. Excellent written and verbal communication skills.

The Freudenberg Group is an equal opportunity employer committed to diversity and inclusion. Employment is open to all applicants regardless of race, color, religion, gender, national origin, age, disability, or other protected characteristics.