Senior Regulatory Affairs Specialist
Job Description:
This role will be primarily focused on registrations outside of the US. The responsibilities include:
- Prepare and submit global regulatory applications, (Pre-Submissions, 510ks, IDEs and applicable supplements and annual reports) in countries such as Japan, India, China, Saudi Arabia, Australia, Mexico and Brazil.
- Support U.S. Medical submissions and EU MDR Submissions.
- Review device labeling (including IFU) and advertising materials for compliance with global regulations; analyze and recommends appropriate changes.
- Assess design and manufacturing changes for compliance with applicable regulations and effect on global registrations
- Maintain regulatory files and tracking databases as needed.
- Support quality system audits by notified bodies, government agencies and customers.
- Obtain Medical Device Certificates to Foreign Government (CFGs)
- Support post market surveillance, including preparation of post market clinical follow up plans and reports. Participate in the review of complaints and all other post market-release feedback.
- Submit medical device reports. Support Unique Device Identifier activities.
Requirements:
- 5-10 years of experience with global regulatory submissions and management of Class II electro-mechanical medical devices
- Experience in generating applications and experience in collaboration with internal and external partners to answer any subsequent questions.
- Knowledge of Design Controls and Risk Management practices, regulations and standards, such as FDA QSR's, ISO 13485, ISO 14971, IEC 60601, 60825, and 62366
- Experience with lasers and optical technologies desired, but not necessary
- Strong working knowledge of Microsoft Word and Excel
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