Program Manager, Regulatory Affairs
Job Req code: 692
Category: Regulatory Affairs
We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others. Empowering Healing.
The Program Manager, Regulatory Affairs manages the regulatory aspects of biotechnology-derived products, including applications submitted to the FDA and other regulatory agencies. This individual will lead the US Regulatory Affairs program for development of multiple cell-based products for submission of 510(k), PMA and PMA-S. This position is based at Organogenesis's headquarters in Canton, MA. Limited overnight travel may be required.
• Lead the preparation and submission of any IDE BLA applications.
• Work with cross functional collaborators (such as R&D and Quality) and external consultants, this individual will also advise on regulatory and scientific issues related to the development of these products.
• Have proven experience with successfully leading and writing submissions and expertise in regulatory scientific aspects preferably with biotechnology-derived products.
• Interface directly with governmental personnel and regulators, including scientific reviewers, administrative staff, and management to facilitate the review and approval of regulatory applications and ensure regulatory compliance.
• Responsible for regulatory submissions for bio-technology products including cell-based and tissue derived products. Includes preparation writing and submission of applications for state licenses, for international registrations, and to FDA for products approved/cleared through PMA and 510(k) pathways.
• Manage certain aspects of Medical Device Reporting (MDR), including completion of reporting decision tree and submission of MDRs through FDA gateway
• Interact with government agencies and regulatory authorities, as necessary, to facilitate submission review and product approvals, maintain compliance and communicate pertinent information. Plan and participate in meetings with FDA and provide regulatory support for inspections by government and other regulatory authorities.
• Strong oral and written communication skills, and negotiation skills
• Willing to set and drive aggressive project timelines
• Capable of strategic thinking and proposing innovative solutions to regulatory problems
• A team player, who listens effectively
• Bachelor’s degree in a scientific discipline
• At least 5 years' experience in the medical or life science industry with at least three years of increasingly responsible experience in Regulatory Affairs
• Solid working knowledge of device/biologic development process and of FDA regulatory requirements for biotechnology products in the U.S.
• Must have successfully submitted regulatory filings to the FDA and other regulatory agencies, including 510(k), PMA, PMA-S, and MDR submissions. Experience working on INDs and BLA submissions preferred
• Experience with technical aspects of product development and manufacturing.
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