13 days ago
My client is a highly innovative IVD/Diagnostics company, located in the Pacific Northwest, who is looking for a qualified and adaptable candidate to join the Regulatory team. The Manager of Regulatory Affairs, R&D and Operations is a crucial member of the Regulatory team, responsible for supporting the development and operations teams compliance with FDA, CLIA, CAP, and other global regulatory requirements. As a member of the Product Teams, this position will work cross-functionally to support key regulatory submissions as well as interfacing with regulatory authorities and key business partners.
Key Responsibilities Include:
- Supporting regulatory filings for new product introductions, including providing organization guidance for requirements and authorizing/reviewing regulatory filing documentation
- Reviewing and approving relevant regulatory filing documentation
- Developing and executing change notification strategies for changes to registered products
- Providing timely regulatory assessments to support the company's change control process
- Contributing to agency communications in the event of notifiable nonconformances or adverse events
- Owning and managing applicable regulatory processes and documents related to R&D and Operations
- Working with quality system process owners to identify and interpret applicable regulations and to mitigate any gaps
- Supporting operations by reviewing incoming project contracts and provide guidance for regulatory requirements for projects, as required
- Informing the cross functional team of any new or revised standards, expanded claims, recalls, adverse events, and impact on the IVD product and provide the appropriate data to the Project Lead to prepare Post Launch Monitoring Annual Report
Experience And Qualifications
- Bachelor’s degree in relevant science, medical or technical field is required; an advanced degree (Masters, PhD) is preferred; (an equivalent combination of education and experience may be considered).
- A breadth of regulatory experience with at least of 6 years in a medical device and/or diagnostics company involved with development, manufacturing, testing and distributing products.
- Experience with U.S. and international IVD regulations.
- Companion Diagnostics experience and alliance partnership experience is highly preferred.
- Track record of working successfully on cross-functional project teams.
- Exceptional communication skills (verbal/written/presentation/relationship building) with ability to work collaboratively in cross-functional project teams and with regulators.
- Broad knowledge of post market surveillance regulations, practices, and procedures.
- Organized and detail-oriented.
- High level of accountability, initiative, and integrity