TFS HealthScience
Director, Regulatory Affairs – Device Expert - Freelance
TFS HealthScience, Washington, District of Columbia, us, 20022
About TFS Healthscience
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.
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
Qualifications
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.
What We Offer 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
A Bit More About Us 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 Healthscience 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
#J-18808-Ljbffr
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.
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
Qualifications
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.
What We Offer 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
A Bit More About Us 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 Healthscience 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
#J-18808-Ljbffr