Regulatory Compliance Specialist

Medasource; New Jersey; Remote; USD 80,000 - 120,000; Full time

Job summary

A leading pharmaceutical firm is seeking a Regulatory Compliance Specialist to support a Quality Management System initiative focused on drug/device combination products. The role involves ensuring compliance with EU clinical trial regulations and streamlining internal processes. Ideal candidates will have strong experience in regulatory compliance and a proven track record in a pharmaceutical setting. This is a full-time, remote position with a preference for East Coast candidates.

Qualifications

• Proven experience in EU quality and regulatory compliance for investigational products.
• Experience building QMS for large pharmaceutical organizations.
• Ability to guide less experienced team members if needed.

Responsibilities

• Assess the current QMS against EU clinical trial regulations.
• Modify, map, or develop new processes for regulatory compliance.
• Provide regulatory input for SOP development.

Skills

EU quality and regulatory compliance

Drug/device combination product regulations

Clinical trials in EU and US

Knowledge of regulatory frameworks in Spain and France

Writing and revising SOPs

Job description

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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)

Overview

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.

Responsibilities

• 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.

Required Skills & Experience

• 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.

Preferred Qualifications

• 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.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Consulting

Industries

• Pharmaceutical Manufacturing