At least 5 years
Job Description
The Regulatory Specialist (EU MDR) is responsible for supporting and executing regulatory activities required to maintain compliance with the European Union Medical Device Regulation (EU MDR 2017/745). This role will collaborate closely with cross-functional teams, including Quality, Engineering, Clinical, and Manufacturing, to ensure regulatory requirements are integrated throughout the product lifecycle. The ideal candidate has a strong working knowledge of EU MDR, technical documentation requirements, post-market surveillance, and notified body processes.
Responsibilities
- Prepare, update, and maintain EU MDR-compliant Technical Documentation, including Risk Management Files, Biological Safety documentation, and GSPRs.
- Support submission activities for Notified Body review, including responses to NB questions and corrective actions.
- Maintain regulatory documentation in accordance with EU MDR Article 10 and Annex II/III requirements.
- Ensure product labeling, IFUs, and UDI requirements comply with EU MDR and other global regulatory standards.
- Partner with R&D and Engineering on design controls, change assessments, and impact analyses to ensure continued EU MDR compliance.
- Support Clinical Affairs with clinical evaluation, PMS, and PMCF requirements as applicable.
- Contribute to developing and maintaining PMS Plans, PMCF Plans, and Periodic Safety Update Reports (PSURs).
- Review and assess post-market data for regulatory impact and reporting obligations.
- Monitor regulatory changes, guidance updates, standards (EN/ISO), and notified body expectations related to EU MDR.
- Assist in the development and execution of regulatory strategies for on-market products.
- Represent Regulatory Affairs in internal meetings and cross-functional project teams.
- Bachelor’s degree in a scientific, engineering, or regulatory field.
- 2–5+ years of regulatory affairs experience in the medical device industry.
- Demonstrated experience working with EU MDR (2017/745) and Technical Documentation preparation.
- Strong understanding of ISO and EU MDR Annexes II & III requirements.
- Excellent written and verbal communication skills.
- Ability to work independently in a fully remote environment.
- Experience interacting with Notified Bodies.
- Experience with Class IIa, IIb, or III devices.
- RAPS RAC certification (RAC EU, RAC Device, or equivalent).
- Familiarity with clinical evaluation and PMCF activities.
- Experience with SaMD (Software as a Medical Device), if applicable.
This is a fully remote position, allowing you to work independently from any location. You will collaborate with various teams across the organization, utilizing modern communication and project management tools to ensure effective cross-functional collaboration.
Job Type & Location
This is a Contract position based out of Centennial, CO.
Pay and BenefitsThe pay range for this position is $71.00 - $71.00/hr.
Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
This is a fully remote position.
Application DeadlineThis position is anticipated to close on Jul 30, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: 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.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
Posting ID: JP-006160296