The Manager, Regulatory Affairs works independently and uses regulatory knowledge to prepare, obtain, and maintain global regulatory clearances, approvals, and compliance. This includes US FDA, EU CE Marking (MDD/MDR), and ROW regulatory guidelines and activities.
- Support the development of the Regulatory Affairs department and team.
- Support RA functional area in the review and approval of Change Orders.
- Prepare and support development of Clinical Evaluation Reports (CERs).
- Keep abreast of pending changes in US regulations and their impact on the company.
- Identify and participate in regulatory risk identification and reduction strategies related to pre and post market products.
- Act as a primary internal expert on preclinical testing of products in support of US and International regulatory submissions.
- Review product labeling and marketing material in support of, and in compliance with US and International regulatory submissions/clearances/approvals.
- Prepare and oversee regulatory documentation in support of marketing applications for US product clearance/approvals, EU CE Marking (technical files/design and dossiers) and ROW registrations, etc.
- Support routine and special regulatory activities required to support and maintain global regulatory clearances/approvals, including quality compliance, QSR/GMP support, EU MDR support, and global post-market surveillance activities.
- Other duties assigned, as necessary.
- Bachelor’s degree in life sciences or related field; preferred, OR equivalent combination of education and experience to perform at this level.
- Minimum three (3) years of experience in Regulatory Affairs within the medical device industry.
- Ability to interpret subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated regulations.
- Knowledge of US FDA, CFRs, QSRs, EU MDD/MDR, and ISO 13485.
- Ability to think critically and always forward thinking.
- Ability to thrive in a fast-paced and dynamic work environment.
- Detail oriented with well-developed writing and analytical skills.
- Excellent, proven interpersonal, verbal, and written communication skills.