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Regulatory Affairs Compliance Team Lead

£35000 - £45000 per annum

Regulatory Affairs Team Lead - Medical Devices

Location: Glasgow, United Kingdom

FPSG is working with a leading medical device company dedicated to developing innovative solutions that improve patient outcomes. With a commitment to excellence and a passion for advancing healthcare, we are seeking a talented Regulatory Affairs Team Lead to join our dynamic team in Glasgow.

Job Overview:

As the Regulatory Affairs Team Lead, you will play a pivotal role in ensuring compliance with regulatory requirements for our range of medical devices. You will lead a team of regulatory professionals, providing guidance, expertise, and strategic direction to ensure successful product registrations, submissions, and compliance activities.

Key Responsibilities:

  • Lead and manage the Regulatory Affairs team, providing mentorship, guidance, and professional development opportunities.
  • Develop and implement regulatory strategies for new product submissions, including 510(k) filings, CE marking, and international registrations.
  • Prepare, review, and submit regulatory documents to health authorities, ensuring accuracy, completeness, and compliance with relevant regulations.
  • Serve as the primary point of contact for regulatory agencies, addressing inquiries, submissions, and audits.
  • Collaborate cross-functionally with R&D, Quality Assurance, Clinical Affairs, and Marketing teams to support product development and launch activities.
  • Stay updated on changes to regulatory requirements and industry standards, advising the organization on implications and strategies.
  • Lead regulatory intelligence activities, conducting competitive assessments and monitoring regulatory trends.
  • Participate in risk management activities, including hazard analysis, risk assessments, and mitigation strategies.
  • Ensure compliance with ISO, FDA, EU MDR, and other applicable regulations, standards, and guidelines.


  • Bachelor's degree in a scientific or technical discipline; advanced degree (e.g., MSc, PhD) preferred.
  • Minimum of 5 years of experience in regulatory affairs within the medical devices industry.
  • Demonstrated experience leading regulatory submissions for medical devices (510(k), PMA, CE marking, etc.).
  • Strong knowledge of FDA regulations (21 CFR), ISO 13485, and EU Medical Device Regulation (MDR).
  • Proven leadership and team management skills, with a track record of developing high-performing teams.
  • Excellent communication skills, with the ability to effectively collaborate across functions and influence stakeholders.
  • Strategic thinker with the ability to analyze complex regulatory issues and develop innovative solutions.
  • Detail-oriented with a commitment to quality and compliance.
  • Regulatory affairs certifications (RAC) desirable.

We are Disability Confident and neurodiverse aware. If you have a disability, please tell us if there are any reasonable adjustments we can make to assist you in your application or with your recruitment process

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