Director, Regulatory Affairs – Device Expert - Freelance
About The Position
TFS HealthScience is a leading global, full-service Contract Research Organization (CRO) providing clinical development and regulatory services to pharmaceutical, biotechnology, and medical device companies. With a strong scientific foundation and a collaborative culture, TFS supports innovative therapies and technologies from early development through commercialization. TFS is seeking a highly experienced Freelance Director, Regulatory Affairs – Device Expert to support our growing medical device and combination product portfolio. This senior-level role will provide strategic regulatory leadership across FDA device and drug programs, supporting FDA Q-Submission, IDE, 510(k) and PMA and other FDA meetings and advice requests as needed. This position is ideal for an accomplished regulatory professional who currently works as Freelance / Contractor only. The FTE of the role is flexible and dependent on business needs - up to 0.5 FTE.
Requirements
- Advanced degree in Life Sciences or related field
- 9+ years of experience in the field
- Expert-level knowledge of both FDA Drug (IND) and Device (IDE) submissions
- Extensive hands-on experience with FDA Agency Meetings
- Proven experience supporting proposals, RFPs, and bid defense meetings
- Demonstrated leadership of 510(k) submissions
- Strong understanding of both drug and medical device clinical trial regulations, quality systems, and FDA expectations
Responsibilities
- Support USA/FDA IND (Investigational New Drug) and IDE (Investigational Device Exemption) submissions, 510(k) and Pre Market Authorisation (PMA) strategy
- USA/FDA support of the strategy teams at the Business Units to develop a regulatory and Startup strategy for new device and combination products focused RFPs and Projects
- USA/FDA regulatory device support for setting up new systems for Startup
- USA/FDA regulatory device support of capabilities and bid defense meetings
- Lead and develop TFS device clinical study capabilities and services, including budget development, process updates and through collaboration with all key functions
Benefits
- We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients
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What This Job Offers
Job Type
Part-time
Career Level
Senior
Education Level
No Education Listed
Number of Employees
501-1,000 employees
