JOB OBJECTIVE: Regulatory Affairs Manager is responsible for leading the overall Regulatory Affairs strategy and direction for Promega (e.g. premarket, adverse event reporting, recalls, regulatory policy and advocacy for the US and worldwide). Provide regulatory support to ensure that Promega Products comply with relevant domestic and international medical device regulations. Develop and maintain required documentation to support regulated products.
1. Interpret and apply applicable laws, regulations and guidelines applicable to devices to meet business objectives.
2. Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance, and then assist the organization in driving implementation.
3. Develop regulatory strategies, in conjunction with business objectives, and translate plans into operational deliverables (i.e. submissions); advise company on regulatory issues concerning products and operations.
4. Manage regulatory activities in respect to quality and timeliness including product recalls, corrections and removals, medical device reporting and materials for submissions.
5. Mentor, coach or train team members on activities within areas of responsibility.
6. Serve as a subject matter expert or actively participate on projects, corrective actions and quality plans to develop and improve processes to ensure Regulatory compliance.
7. Monitor regulatory changes globally; evaluate impact on Promega; develop and implement necessary changes.
8. Evaluate performance metrics to identify program weaknesses & drive improvements in procedures or oversight.
9. Review product labeling, risk assessments, promotional materials.
10. Create and manage regulatory plans for new product introductions.
11. Provide Pre- and Post-market regulatory support for Promega products.
12. Understands and complies with ethical, legal and regulatory requirements applicable to our business.
1. Organize and implement training programs in areas of Regulatory Affairs.
1. Bachelor’s Degree and minimum of 10 years experience with increasing responsibilities in the medical device (prefer IVD) including knowledge and experience applying global device laws & regulations for product registration, adverse event reporting, and recalls; interfacing with regulatory bodies.
2. Regulatory Affairs Certification (RAC).
3. At least 5 years RA leadership experience, including training and coaching of team members.
4. Strong understanding of US and European IVD medical device regulations.
5. Demonstrated knowledge of regulatory issues and experience interfacing with local and internationals regulatory bodies, such as FDA, European competent authorities and notified bodies.
6. Demonstrated experience with the development of submissions and regulatory responses.
7. Ability to prioritize, plan, delegate and evaluate deliverables to established strategic goals.
8. Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English, tailoring communication methods to customer’s requirements.
9. Ability to influence and make recommendations at all levels of the company.
1. Advanced degree in scientific discipline.
2. Medical device product action experience.
3. Experience with Complaint Handling, Adverse Event and Recall Reporting Systems.
4. Experience supporting IVD products.
5. Experience with IVD product registration in Asia.
1. Ability to use office equipment including computer equipment.
Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.