Director, Regulatory Affairs – Device Expert - Freelance jobs in United States
info-icon
This job has closed.
company-logo

TFS HealthScience · 7 hours ago

Director, Regulatory Affairs – Device Expert - Freelance

positionUnited States
timeContract
remoteRemote
seniorityDirector/Executive
date9+ years exp

TFS HealthScience is a leading global Contract Research Organization providing clinical development and regulatory services. They are seeking a highly experienced Freelance Director, Regulatory Affairs – Device Expert to provide strategic regulatory leadership across FDA device and drug programs, supporting various regulatory submissions and strategy development.

Clinical TrialsHealth CarePharmaceutical

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

Qualification

FDA Drug submissionsFDA Device submissionsFDA Agency Meetings510(k) submissionsRegulatory leadershipLife Sciences degreeExperience in regulatory affairs

Required

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

Benefits

Comprehensive benefits

Company

TFS HealthScience

twittertwittertwitter
company-logo
TFS HealthScience is a full-service, global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance innovative treatments and improve patient outcomes.
dateFounded in 1996
location
Lund, Skane Lan, SWE
people-size501-1000 employees
web-link
https://www.tfscro.com

Funding

Current Stage
Late Stage
Total Funding
unknown
2015-09-07Acquired

Leadership Team

leader-logo
Jordan Reed
Senior Finance Business Partner
linkedin

Recent News

PR Newswire UK
TFS HealthScience Strengthens Global Ophthalmology Unit with Strategic Hires and Integrated Delivery Model
2025-07-16
PR Newswire
TFS HealthScience Appoints Miriam Martin as Vice President of Business Development, Clinical Development Services
2025-03-25
prnewswire.co.uk
TFS HealthScience Announces Leadership Transition: Katarina Ageborg Appointed Chairman of the Board, Markus Granlund Named Acting CEO
2025-02-24
Company data provided by crunchbase