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