Job Description

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

Job Tags

Similar Jobs