Senior Manager Regulatory Affairs
On-site - Cincinnati, Ohio (Relocation provided)
My client is a leading medical device life science company that develops, manufactures, markets, and distributes a broad range of innovative diagnostic products. The Senior Manager Regulatory Affairs, Pre-Market and International, will be responsible for managing RA personnel involved in all stages of the product lifecycle, including research, development, transfer, validation/verification, labeling, global regulatory submissions, and lifecycle maintenance.
Summary and Qualifications:
- Supervise, oversee, and participate in drafting of regulatory submissions for United States FDA (510(k), etc) and international markets in support of business objectives.
- Manages employees, including hiring, performance evaluations and coaching.
- Manages complex, long-term projects supporting the business and quality objectives of the organization. Projects can be cross-functional and cross-site.
- Reviews, and helps provide guidance for product labeling, including Instructions for Use (IFU/PI), to ensure adherence to applicable regulations and standards.
- Demonstrated knowledge of FDA regulations, In Vitro Diagnostic Directive, In Vitro Diagnostic Regulation and other national and international regulations and standards.
- Demonstrated strong leadership, project management, organization, and oral and written communication skills.
Education and Experience:
- Bachelor's or master's degree in Biology, Biochemistry, Microbiology, Engineering, or Regulatory Affairs. Master's degree is preferred.
- Professional certification (RAC) required
- 7 -10 years of direct experience in the medical devices industry, preferably with in vitro diagnostic devices; experience regarding medical device design, development, and manufacturing regulations, especially 21 CFR Part 820 Quality System Regulation, IVD Directive 98/79 EC, IVDR 2017/746, as well as ISO 13485 requirements.
- Proven knowledge of international regulations for product registration. Experience in preparation of international registration applications, EU Technical Files, Canadian Class II and III licenses, STED documentation, etc.
- Experience with applying ISO 14971 principles to medical devices throughout all stages of the product's lifecycle.
- A minimum of 7+ years of direct management experience is required, remote management experience a plus.
- Premarket Experience: Experience supporting medical device regulatory submissions (e.g., 510(k)s and/or PMAs); proven experience with application of quality and regulatory requirements in the design and development of medical devices.
- History of successful 510(k) clearances and/or PMA approvals of in vitro diagnostic devices.
Please don't hesitate to reach out and apply! If you know of anyone in your network who could be a good fit - please share!
