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Regulatory Compliance Specialist

Regulatory Compliance Specialist

MedasourceCambridge, Massachusetts, United States
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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

  • Proven 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
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    Regulatory Compliance Specialist • Cambridge, Massachusetts, United States

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