At a Glance
- Tasks: Lead compliance and safety initiatives across EMEA, ensuring top-notch quality and regulatory adherence.
- Company: Join a leading medical device company committed to innovation and patient safety.
- Benefits: Enjoy hybrid work options, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact in healthcare while collaborating with diverse teams and experts.
- Qualifications: BA/BS preferred; experience in Quality Assurance or Regulatory Affairs is a plus.
- Other info: Up to 20% travel may be required; strong attention to detail is essential.
The predicted salary is between 36000 - 60000 £ per year.
The Manager of EMEA Safety and Compliance develops, establishes, and maintains quality assurance methodologies, systems, and medical device industry best practices to meet customer, regulatory, and client requirements. This individual serves as a post-market surveillance subject matter expert for the region, providing support to internal teams such as complaint evaluation, reportability determination, complaint investigation, health hazard evaluation, risk file review, CAPA, legal, Medical Affairs, and field actions. Support includes guidance on regulations, risk management, impact assessment, GPM approval, and compliance review.
Responsibilities:
- Support and collaborate with all involved groups in the PMS and vigilance processes across Europe, Middle East, and Africa (EMEA) to ensure compliance, reliability, effectiveness, and efficiency, including customer care, global PMS, authorized representatives, distributors, and authorities.
- Lead a team managing and responding to requests from Competent Authorities, liaising with internal SMEs, and providing analysis and responses to adverse events and safety signals.
- Oversee the Critical Complaint Triage (CCT) process.
- Manage a team supporting post-market activities, new market entries, and product line expansions, fostering a collaborative and high-performing culture.
- Support audits by notified bodies, authorities, and internal teams related to PMS and vigilance activities.
- Align PMS and quality strategies with business objectives to support commercial teams.
- Engage with patients and healthcare professionals for complaint follow-up and additional information.
- Collaborate on compliance documentation such as PMS plans, HHEs, CAPAs, legal activities, and field actions.
- Maintain knowledge of products, labeling, indications, and disease states.
- Partner with RA/QA, legal, Medical Affairs, and field staff on safety communications and investigations.
- Stay informed on relevant regulations and guidelines, including ISO 14971, FDA, MDCG, IMDRF, and ICH.
- Contribute to post-market compliance initiatives, process improvements, and safety principles.
- Provide training to international field staff on complaint recognition and documentation.
Education and Experience:
- BA/BS degree preferred.
- Experience in Quality Assurance, Regulatory Affairs, Post Market Surveillance, or Medical/Clinical/Patient Safety.
- Experience in technical writing within regulated industries.
- Background in clinical risk management, compliance, or post-market safety.
- Fluency in Medical Device regulations (EUMDR, FDA, ISO13485).
- Proficiency in Microsoft Office.
- Ability to interpret scientific content and adapt communication accordingly.
- Quick learner of new technologies.
- Strong attention to detail and excellent grammatical skills.
Preferred Skills:
- Experience dealing with regulatory bodies.
- Healthcare licensure or specialized certifications (e.g., BSN, Registered Dietician).
- Experience with SaMD.
- Global team leadership experience.
Physical Requirements:
- None, up to 15-20% travel may be required.
EMEA Compliance and Vigilance Manager (hybrid) employer: Insulet
Contact Detail:
Insulet Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land EMEA Compliance and Vigilance Manager (hybrid)
✨Tip Number 1
Familiarise yourself with the latest regulations and guidelines relevant to the medical device industry, such as ISO 14971 and EUMDR. This knowledge will not only help you in interviews but also demonstrate your commitment to compliance and safety.
✨Tip Number 2
Network with professionals in the field of post-market surveillance and compliance. Attend industry conferences or webinars to connect with potential colleagues and learn about current trends and challenges in the EMEA region.
✨Tip Number 3
Prepare to discuss specific examples from your past experience that showcase your ability to manage compliance processes and lead teams effectively. Highlight any successful projects where you improved safety or compliance outcomes.
✨Tip Number 4
Demonstrate your understanding of the importance of collaboration across various departments. Be ready to explain how you would engage with internal teams and external stakeholders to ensure compliance and enhance post-market activities.
We think you need these skills to ace EMEA Compliance and Vigilance Manager (hybrid)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Quality Assurance, Regulatory Affairs, and Post Market Surveillance. Use keywords from the job description to demonstrate your fit for the role.
Craft a Compelling Cover Letter: Write a cover letter that showcases your understanding of compliance and vigilance in the medical device industry. Mention specific experiences that align with the responsibilities outlined in the job description.
Highlight Technical Writing Skills: Since technical writing is crucial for this role, provide examples of your previous work in regulated industries. Include any documentation you have created related to compliance or safety.
Showcase Leadership Experience: If you have experience leading teams or projects, make sure to include this in your application. Discuss how you fostered collaboration and high performance, as these are key aspects of the role.
How to prepare for a job interview at Insulet
✨Know Your Regulations
Familiarise yourself with key regulations such as ISO 14971, EUMDR, and FDA guidelines. Being able to discuss these in detail will demonstrate your expertise and understanding of the compliance landscape.
✨Showcase Your Experience
Prepare specific examples from your past roles that highlight your experience in Quality Assurance, Regulatory Affairs, or Post Market Surveillance. Use the STAR method (Situation, Task, Action, Result) to structure your responses.
✨Emphasise Team Collaboration
Since the role involves working with various internal teams and external authorities, be ready to discuss how you have successfully collaborated in the past. Highlight any leadership experiences and how you fostered a high-performing culture.
✨Prepare for Technical Questions
Expect questions related to complaint evaluation, risk management, and post-market activities. Brush up on your technical writing skills and be prepared to explain complex concepts in a clear and concise manner.