Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead a team ensuring compliance for medical device regulations and submissions.
- Company: Join a leading medical device company focused on innovative healthcare solutions.
- Benefits: Enjoy professional development, mentorship, and a collaborative work environment.
- Why this job: Make a real impact in healthcare while advancing your career in a dynamic team.
- Qualifications: Bachelor's degree required; 5+ years in regulatory affairs preferred.
- Other info: We support diversity and are committed to making reasonable adjustments for applicants.
The predicted salary is between 43200 - 72000 £ per year.
Regulatory Affairs Team Lead – Medical DevicesLocation: Glasgow, United KingdomFPSG 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.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
#J-18808-Ljbffr
Regulatory Affairs Compliance Team Lead employer: FPSG
Contact Detail:
FPSG Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Compliance Team Lead
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience in medical devices. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and requirements.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks relevant to the role, such as FDA regulations and EU MDR. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 3
Prepare to discuss your leadership experiences in detail. Think of examples where you've successfully led a team through complex regulatory submissions or compliance challenges, as this will be crucial for the Team Lead position.
✨Tip Number 4
Research the company’s recent projects and regulatory achievements. Being able to reference specific initiatives during your discussions will show your genuine interest in the role and the organisation.
We think you need these skills to ace Regulatory Affairs Compliance Team Lead
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the Regulatory Affairs Compliance Team Lead position. Tailor your application to highlight relevant experiences that align with these requirements.
Craft a Strong CV: Your CV should clearly outline your experience in regulatory affairs, particularly within the medical devices industry. Emphasise your leadership skills and any successful submissions you've managed, such as 510(k) filings or CE marking.
Write a Compelling Cover Letter: In your cover letter, express your passion for regulatory affairs and how your background makes you a perfect fit for the role. Mention specific examples of your achievements and how they relate to the job description provided by the company.
Highlight Relevant Certifications: If you have any regulatory affairs certifications, such as RAC, be sure to include them in your application. This can set you apart from other candidates and demonstrate your commitment to the field.
How to prepare for a job interview at FPSG
✨Know Your Regulations
Familiarise yourself with the key regulations relevant to the role, such as FDA regulations, ISO 13485, and EU MDR. Being able to discuss these in detail will demonstrate your expertise and commitment to compliance.
✨Showcase Leadership Experience
Prepare examples of how you've successfully led teams in the past. Highlight your mentorship skills and how you've developed high-performing teams, as this is crucial for the Regulatory Affairs Team Lead position.
✨Prepare for Cross-Functional Collaboration
Think about instances where you've worked with R&D, Quality Assurance, or Clinical Affairs. Be ready to discuss how you can facilitate collaboration across departments to support product development and compliance.
✨Stay Updated on Industry Trends
Demonstrate your knowledge of current trends and changes in regulatory requirements. Discuss how you keep informed and how you would advise the company on implications and strategies related to these changes.
