Regulatory Affairs Associate; Medical Devices

Puesto: Regulatory Affairs Associate (Medical Devices)
INTER REGULATORY   Inter Regulatory is a specialist regulatory compliance consultancy supporting highly regulated industries including medical devices, pharmaceuticals, nicotine products, and cosmetics.

With offices in Liverpool, Virginia, Barcelona, and Shenzhen, we support clients across the UK, US, EU, and China, combining region-specific regulatory expertise with globally integrated compliance strategies.

Our approach is compliance-first and evidence-driven. We deliver regulatory strategy, technical documentation development, authority engagement support, and post-market compliance oversight. We operate as an extension of our clients’ regulatory and quality functions, ensuring defensible submissions, structured governance, and commercially viable market access.

We are focused on clarity, accountability, and regulatory credibility in complex product environments.

Role Description   We are seeking a full-time Regulatory Affairs Associate (Medical Devices) to join our Barcelona team (hybrid working model).

This role supports the preparation, review, and maintenance of regulatory documentation in accordance with EU MDR (Regulation (EU) 2017/745) and UK MDR 2002. The position involves structured collaboration with Technical Leads and Quality personnel to deliver compliant technical documentation and support regulatory submissions.

Key responsibilities include:

• Supporting the preparation and maintenance of EU MDR Technical Documentation (Annex II & III)

• Assisting with GSPR compliance demonstration and risk management alignment (ISO 14971)

• Supporting Clinical Evaluation and Post-Market Surveillance documentation

• Assisting with regulatory gap assessments and compliance reviews

• Supporting labelling, IFU, and UDI compliance activities

• Monitoring regulatory developments and harmonised standards

• Coordinating regulatory documentation activities in line with project timelines
The role operates within a defined technical review framework and provides exposure to multi-jurisdictional
regulatory projects.

Qualifications   We are seeking candidates with:

• 2–3 years’ experience in medical device regulatory affairs

• Direct involvement in EU MDR Technical Documentation preparation or maintenance

• Working knowledge of ISO 13485 and ISO 14971

• Strong understanding of regulatory compliance frameworks within the medical device industry

• Experience supporting regulatory submissions and technical file compilation

• Excellent organisational and technical writing skills

• Ability to interpret and apply complex regulatory requirements

Required:

• Bachelor’s degree in Biomedical Engineering, Life Sciences, Electronics Engineering, or related scientific discipline

• Professional fluency in English