Regulatory Affairs Compliance Team Lead
FPSG
- Glasgow
- £35,000-45,000 per year
- Permanent
- Full-time
- 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.