Director, Regulatory Affairs – Device Expert - Freelance

About TFS Health science

TFS Health Science 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.

• 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

• 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

Please, keep in mind that we can only offer a Freelance contract for this role.

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

Our journey began over 25 years ago in Sweden, in the city of Lund. As a global CRO with the ultimate goal of ensuring patients’ safety and well-being, we provide biotechnology and pharmaceutical companies with tailored clinical development solutions. We currently operate in 17 countries across Europe, North America, Asia Pacific and the Middle East.

Our core values of Trust, Quality, Flexibility and Passion are what make TFS Health science the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization.

#Together we make a difference