Director, Regulatory Affairs – Device Expert - Freelance

TFS HealthScience • Washington, WA

9h

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.

The Role 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

What This Job Offers

• Job Type: Part-time
• Career Level: Director
• Education Level: No Education Listed
• Number of Employees: 501-1,000 employees