Regulatory Compliance Specialist

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