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
Youll play a key role in ensuring compliance with EU clinical trial regulationsparticularly in Spain (AEMPS) and France (ANSM)while helping streamline regulatory and quality processes across global teams.
What Youll 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 Were Looking For
Proven experience in EU quality and regulatory compliance for investigational productsDeep understanding of drug / device combination product regulationsExperience building or amending QMS in large pharma settingsStrong knowledge of AEMPS and ANSM requirementsAbility to work independently and provide hands-on compliance expertiseExperience supporting EU and US clinical trials