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- Tasks: Lead compliance and safety initiatives across EMEA, ensuring top-notch quality assurance.
- Company: Join Insulet Corporation, a leader in diabetes management innovation.
- 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 degree preferred; experience in Quality Assurance or Regulatory Affairs is essential.
- Other info: Up to 20% travel may be required; join us in transforming diabetes care!
The predicted salary is between 43200 - 72000 £ per year.
The Manager of EMEA Safety and Compliance develops, establishes, and maintains quality assurance methodologies, systems, and medical device industry best practices which meet customer, regulatory, and client requirements; and serves as a post-market surveillance subject matter expert to the region. This individual will provide support to internal functional teams involved in complaint evaluation, reportability determination, complaint investigation, health hazard evaluation, risk file review, CAPA, legal, Medical Affairs, and field actions.
Responsibilities:
- Support and collaborate with all groups involved in PMS and vigilance processes to ensure compliance and effectiveness, including customer care, global PMS, regional representatives, distributors, and authorities.
- Lead a team managing responses to requests from Competent Authorities, liaising with SMEs, and providing analysis of adverse events and safety signals.
- Oversee critical complaint triage (CCT) process and support post-market activities, product launches, and expansion in the region, fostering a team culture of collaboration and trust.
- Support audits and ensure alignment of PMS strategies with business objectives.
- Engage with patients and healthcare professionals for additional information and support during complaint follow-up.
- Collaborate on compliance documentation, including PMS plans, HHEs, CAPAs, legal activities, and field actions.
- Maintain knowledge of products, regulations (ISO 14971, FDA, MDCG, IMDRF, ICH), and industry standards.
- Contribute to compliance programs, process improvements, and safety practices.
- Provide training on complaint recognition and documentation to field staff.
Education and Experience:
Minimum Requirements:
- BA/BS degree (preferred)
- Experience in Quality Assurance, Regulatory Affairs, Post Market Surveillance, or Medical/Clinical/Patient Safety in healthcare or medical technology
- Experience in technical writing within regulated industries
- Knowledge of clinical risk management, compliance, or safety
- Fluent in Medical Device regulations (EU MDR, FDA, ISO 13485)
- Proficiency in Microsoft Office
- Ability to interpret scientific content and learn new technologies quickly
- Strong attention to detail and communication skills
Preferred Skills:
- Experience with regulatory bodies
- Healthcare licensure or diabetes-related qualifications
- Experience in SaMD and leading global teams
Physical Requirements:
None. Up to 15-20% travel possible.
Insulet Corporation, NASDAQ: PODD, is dedicated to innovating in diabetes management and healthcare. For more info, visit insulet.com and omnipod.com.
We seek motivated, high-performing individuals guided by shared values to join our team and exceed customer expectations.
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EMEA Compliance and Vigilance Manager (hybrid) employer: Insulet Corporation
Contact Detail:
Insulet Corporation 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 specific regulations and standards mentioned in the job description, such as ISO 14971 and EU MDR. This knowledge will not only help you understand the role better but also demonstrate your commitment to compliance during any discussions.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who have experience in post-market surveillance and compliance. Engaging with them can provide insights into the role and may even lead to referrals or recommendations.
✨Tip Number 3
Prepare to discuss your experience with complaint evaluation and risk management in detail. Be ready to share specific examples of how you've handled similar situations in the past, as this will showcase your expertise and problem-solving skills.
✨Tip Number 4
Stay updated on the latest trends and developments in diabetes management and healthcare technology. Showing that you are proactive about learning can set you apart from other candidates and align you with Insulet Corporation's innovative spirit.
We think you need these skills to ace EMEA Compliance and Vigilance Manager (hybrid)
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the EMEA Compliance and Vigilance Manager position. Familiarise yourself with the key skills needed, such as knowledge of medical device regulations and experience in quality assurance.
Tailor Your CV: Customise your CV to highlight relevant experience in Quality Assurance, Regulatory Affairs, and Post Market Surveillance. Emphasise your technical writing skills and any specific knowledge of regulations like EU MDR and ISO 13485.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for compliance and safety in the healthcare sector. Mention specific experiences that align with the job description and demonstrate how you can contribute to Insulet Corporation's goals.
Proofread Your Application: Before submitting, carefully proofread your application materials. Check for spelling and grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail, which is crucial for this role.
How to prepare for a job interview at Insulet Corporation
✨Know Your Regulations
Familiarise yourself with key regulations such as ISO 14971, EU MDR, and FDA guidelines. Being able to discuss these in detail will show your expertise and understanding of the compliance landscape.
✨Demonstrate Team Collaboration
Prepare examples of how you've successfully collaborated with cross-functional teams in previous roles. Highlighting your ability to work with various stakeholders will be crucial for this managerial position.
✨Showcase Your Technical Writing Skills
Since technical writing is a significant part of this role, bring samples of your previous work or be ready to discuss your writing process. This will demonstrate your capability to produce clear and compliant documentation.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios related to post-market surveillance and complaint management. Practising these types of questions can help you articulate your thought process effectively.
