Medical Device Regulatory Affairs Project Manager - North Boston (closed)
We are a leading provider of medical solutions in the dental field.
Develop regulatory strategies, plan and prepare US regulatory submissions for new product registration PMA, 510(k), and Annual Reports for several business units (including the regenerative unit) and manage product regulatory files for impact of changes which could significantly affect the safety or effectiveness of a product. Additionally this position will support the review and analyze of product labeling, advertising and promotional materials for US FDA compliance. This position will be jointly responsible for regulatory operations include new plant registrations, FDA annual re-registration for the existing 6 plants, all new device listings, import/export issues, and directing the compilation of all submission related material.
Major Responsibilities of the Position:
• Implement US Regulatory Strategies for certain business units, working closely with the US Regulatory Director, Global Regulatory Project Managers, and other Regulatory Project Managers
• Responsible for FDA clearance or approval for new products, new indications and/or new claims in accordance with product launch timelines
• Works closely with several business units to develop new product applications or submissions
• Working closely with Regulatory Director, responsible for interaction with FDA reviewers regarding product approval or clearance
• Conducts on-going regulatory surveillance to remain current regarding FDA current thinking and competitor clearances and approvals.
• Reviews marketing literature for FDA compliance, in particular ensuring marketing literature confirms to product clearances or approvals.
• Monitor changes to regulated product which may impact US clearance and approval. Provide significant oversight to this process by approving/reviewing all memos to files from all business units.
• Ensure compliance to all required external standards
• 6 + years experience working in regulated industry preferably medical devices preparing 510(k), PMA supplements and related annual reports with a successful track record.
• Solid knowledge of US FDA regulations
• Experience with FDA FFC/RD exposure issues
• BSc degree required, preferably in Biology or Chemistry
• Strong project management skills
• Ability to manage multiple tasks
• Ability to collate regulatory intelligence and communicate to relevant business units
• Effective written and oral communication skills
• Capable of creative thinking and problem solving