As a Regulatory Affairs Specialist, you will play a key role in ensuring compliance with FDA and global regulatory requirements while supporting the efficient and cost-effective manufacturing of high-quality medical devices. This role involves managing regulatory documentation, coordinating global submissions, and assisting internal teams to meet corporate registration objectives. Your expertise will help drive timely approvals and ensure alignment with EU MDR and other regulatory standards, contributing to the success of both internal stakeholders and global customers.
Position Type: Contract role for 1 year (through Feb 2026)
Schedule/Shift/Location: REMOTE, 1st shift, Mon.-Fri.
Although this is a remote role, preference will be given to candidates local to Dallas / Fort Worth, TX as occasional in-office visits to Fort Worth would be beneficial.
location: Fort Worth, Texas
job type: Contract
salary: $50.00 - 56.41 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Under guidance, update technical documentation files to align with EU MDR medical device requirements
- Submit Regulatory Impact Assessments to countries using Veeva system and ensure completeness of assessment from countries
- Coordinate submission package and manage country timelines to support approval of lifecycle management changes for medical devices
- Under guidance, collect data from Technical Documentation File in preparation for Eudamed go-live
- Verify registration data in Veeva database for US and Canada medical devices
qualifications:
- Bachelor's Degree (BA/BS)
- 3-5 Years of medical device regulatory experience
- EU MDR
- Strong communication skills, written and verbal
skills: GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, Submissions, Medical Device Product Development
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
