Regulatory Compliance SpecialistMedasource • Cambridge, MA, United States
Regulatory Compliance Specialist
Medasource • Cambridge, MA, United States
16 days ago
Job type
- Full-time
Job descriptionProven experience in EU quality and regulatory compliance for investigational products Deep understanding of drug / device combination product regulations Experience building or amending QMS in large pharma settings Strong knowledge of AEMPS and ANSM requirements Ability to work independently and provide hands-on compliance expertise Experience supporting EU and US clinical trials
Role : Regulatory Compliance Specialist
Contract : ~6 months (potential for extension or early completion)
Location : Remote (East Coast preferred)
Start Date : ASAP
We are looking for a Regulatory Compliance Specialist to support a Critical Quality Management System (QMS) initiative for investigational drug / device combination products for Johnson & Johnson
You’ll play a key role in ensuring compliance with EU clinical trial regulations—particularly in Spain (AEMPS) and France (ANSM)—while helping streamline regulatory and quality processes across global teams.
What You’ll Do
- Operate independently while collaborating with Quality and Clinical Operations teams
- Evaluate and enhance the current QMS for EU clinical trial compliance
- Identify and close compliance gaps across procedures and documentation
- Support the development and simplification of SOPs and engineering documentation
- Provide expert guidance on EU country-specific regulations (Spain and France)
- Lead or support cross-functional QMS initiatives
What We’re Looking For
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Regulatory Compliance Specialist • Cambridge, MA, United States