Regulatory Compliance Specialist

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Regulatory Compliance Specialist – EU Clinical Trials (Drug/Device Combo Products)

Contract Duration: ~6 months (potential for extension or early completion)

Start Date: ASAP

Location: Remote (East Coast preferred)

Our client, a leading pharmaceutical company, is seeking a Regulatory Compliance Specialist to support a high-impact Quality Management System (QMS) initiative focused on investigational drug/device combination products. This role will be instrumental in ensuring compliance with EU clinical trial regulations, particularly in Spain and France, and streamlining internal regulatory processes.

• Operate independently while collaborating closely with internal Quality and Clinical Operations teams.
• Assess the current QMS against EU clinical trial regulations and identify compliance gaps.
• Modify, map, or develop new processes and procedures to ensure regulatory compliance.
• Simplify and streamline existing QMS procedures across all phases of clinical trials.
• Provide regulatory input and support for engineering SOP development.
• Engage with cross-functional teams to ensure alignment with country-specific regulatory requirements.
• Overseeing the QMS initiative.

• Proven experience in EU quality and regulatory compliance for investigational products.
• Deep understanding of drug/device combination product regulations.
• Experience working for a large pharmaceutical company.
• Prior experience amending or building QMS for large pharmaceutical organizations.
• Strong knowledge of country-specific regulatory frameworks, especially:
• Spain (AEMPS)
• France (ANSM)
• Comfortable working independently and guiding less experienced team members if needed.
• Experience supporting clinical trials in both EU and US regulatory environments.

• Ability to write and revise SOPs and support engineering documentation.
• Experience with intertumoral device trials or targeted chemotherapy delivery systems.
• Familiarity with regulatory compliance for combination products (not limited to oncology).
• Based on the East Coast for easier collaboration with team members in Boston and New Jersey.

You’ll be joining a newly assembled team with limited depth in quality and regulatory backgrounds. Your expertise will be critical in supporting the intertumoral device team and ensuring regulatory processes are streamlined and compliant.

Interested candidates should have a strong background in regulatory compliance—not just regulatory affairs—and be ready to make an immediate impact.

• Mid-Senior level

• Full-time

• Consulting

• Pharmaceutical Manufacturing