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.

Qualifications:

• 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.