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:
1. Lead and manage the Regulatory Affairs team, providing mentorship, guidance, and professional development opportunities.
2. Develop and implement regulatory strategies for new product submissions, including 510(k) filings, CE marking, and international registrations.
3. Prepare, review, and submit regulatory documents to health authorities, ensuring accuracy, completeness, and compliance with relevant regulations.
4. Serve as the primary point of contact for regulatory agencies, addressing inquiries, submissions, and audits.
5. Collaborate cross-functionally with R&D, Quality Assurance, Clinical Affairs, and Marketing teams to support product development and launch activities.
6. Stay updated on changes to regulatory requirements and industry standards, advising the organization on implications and strategies.
7. Lead regulatory intelligence activities, conducting competitive assessments and monitoring regulatory trends.
8. Participate in risk management activities, including hazard analysis, risk assessments, and mitigation strategies.
9. Ensure compliance with ISO, FDA, EU MDR, and other applicable regulations, standards, and guidelines.
Qualifications:
10. Bachelor's degree in a scientific or technical discipline; advanced degree (e.g., MSc, PhD) preferred.
11. Minimum of 5 years of experience in regulatory affairs within the medical devices industry.
12. Demonstrated experience leading regulatory submissions for medical devices (510(k), PMA, CE marking, etc.).
13. Strong knowledge of FDA regulations (21 CFR), ISO 13485, and EU Medical Device Regulation (MDR).
14. Proven leadership and team management skills, with a track record of developing high-performing teams.
15. Excellent communication skills, with the ability to effectively collaborate across functions and influence stakeholders.
16. Strategic thinker with the ability to analyze complex regulatory issues and develop innovative solutions.
17. Detail-oriented with a commitment to quality and compliance.
18. 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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