📌 Core Information
🔹 Job Title: Senior Global Product Monitoring Vigilance Report Writer (Remote/Flexible)
🔹 Company: Insulet Corporation
🔹 Location: United Kingdom, France
🔹 Job Type: Full-Time
🔹 Category: Medical Equipment Manufacturing
🔹 Date Posted: 2025-04-23
🔹 Experience Level: 5-10 years
🔹 Remote Status: Remote OK
🚀 Job Overview
Key aspects of this role include:
- Developing and maintaining quality assurance methodologies for medical devices
- Serving as a post-market vigilance and surveillance subject matter expert
- Collaborating with internal and external teams to ensure regulatory compliance
- Supporting management in day-to-day operations and special projects
ASSUMPTION: This role requires a high level of attention to detail, strong communication skills, and the ability to work independently and in a team environment.
📋 Key Responsibilities
✅ Assessing, following up, coding, and vigilance activities for high-priority complaints
✅ Authoring, peer reviewing, and approving vigilance reports for regulatory submissions
✅ Supporting management in day-to-day operations and special projects
✅ Collaborating with internal and external teams to ensure regulatory compliance
✅ Serving as a subject matter expert for post-market and complaint handling regulatory questions
✅ Supporting internal and external audits and inspections
✅ Performing other duties as required
ASSUMPTION: This role involves handling sensitive information and requires a high level of confidentiality and attention to detail.
🎯 Required Qualifications
Education: Bachelor’s degree
Experience: 5 years of demonstrated experience in medical device complaint triage and vigilance reporting or 5 years of clinical experience in diabetes disease management or diabetes device support
Required Skills:
- Strong analytical and problem-solving skills
- Excellent written and verbal communication skills
- Ability to work independently and in a team environment
- Strong proficiency in Microsoft Office (Excel, Word, Outlook)
- Familiarity with complaint database applications
Preferred Skills:
- Direct experience with global, multi-country vigilance reporting requirements for medical devices
- Experience dealing directly with regulatory bodies
- BSN with diabetes experience, Registered or Licensed Dietician, or Diabetic Educator
- Strong knowledge of medical device quality management systems
ASSUMPTION: While a Bachelor’s degree is required, relevant experience may be considered in lieu of a degree for the right candidate.
💰 Compensation & Benefits
Salary Range: $80,000 - $120,000 per year (Based on industry standards for a Senior-level role in Medical Device Vigilance Reporting)
Benefits:
- Health, dental, and vision insurance
- 401(k) plan with company match
- Paid time off (vacation, sick, and holidays)
- Tuition reimbursement
- Employee assistance program
Working Hours: Full-time, flexible hours with some remote work available
ASSUMPTION: The salary range provided is an estimate based on industry standards and may vary depending on the candidate's experience and qualifications.
📌 Applicant Insights
🔍 Company Context
Industry: Medical Equipment Manufacturing, specifically focused on diabetes management and medical devices
Company Size: 1,001-5,000 employees, providing a large, established environment with opportunities for growth and collaboration
Founded: 2000, with over 20 years of experience in the medical device industry
Company Description:
- Innovative medical device company dedicated to simplifying life for people with diabetes and other conditions
- Omnipod product platform provides a unique alternative to traditional insulin delivery methods
- Omnipod 5 Automated Insulin Delivery System integrates with a continuous glucose monitor for improved blood sugar management
Company Specialties:
- Medical Devices
- Diabetic Management
- Biotechnology
- Advanced Manufacturing
- Medical Supply Chain
Company Website: http://www.insulet.com/
ASSUMPTION: Insulet Corporation is a well-established company with a strong reputation in the medical device industry, providing a stable and supportive work environment for its employees.
📊 Role Analysis
Career Level: Senior-level role with opportunities for growth and advancement within the company
Reporting Structure: This role reports directly to the Director of Global Product Monitoring and Vigilance
Work Arrangement: Remote OK, with flexible hours and some remote work available
Growth Opportunities:
- Potential to advance to a management or leadership role within the department
- Opportunities to work on special projects and gain exposure to different aspects of the business
- possibility to transition into other roles within the company as the business grows and evolves
ASSUMPTION: This role offers a high level of responsibility and autonomy, providing an excellent opportunity for career growth and development.
🌍 Location & Work Environment
Office Type: Insulet Corporation has multiple office locations, with this role being remote-friendly
Office Location(s): Acton, Massachusetts (Headquarters), London, England, Oakville, Ontario, and San Diego, California
Geographic Context:
- Acton, Massachusetts: A suburban town with a mix of residential and commercial areas, located about 20 miles northwest of Boston
- London, England: A major global city with a vibrant business district and numerous cultural attractions
- Oakville, Ontario: A suburban town located about 30 kilometers west of Toronto, known for its high quality of life and excellent schools
- San Diego, California: A coastal city with a mild climate, numerous beaches, and a thriving biotech industry
Work Schedule: Full-time, with flexible hours and some remote work available
ASSUMPTION: The remote-friendly work arrangement provides a good balance between work-life integration and the ability to collaborate with team members in different locations.
💼 Interview & Application Insights
Typical Process:
- Phone or video screen with the hiring manager
- In-depth behavioral and technical interview with the Director of Global Product Monitoring and Vigilance
- Final interview with the Vice President of Global Quality and Regulatory Affairs
Key Assessment Areas:
- Problem-solving skills and ability to handle complex, high-priority complaints
- Strong written and verbal communication skills
- Attention to detail and ability to work independently
- Understanding of medical device quality management systems and regulatory requirements
Application Tips:
- Highlight relevant experience in medical device vigilance reporting and regulatory compliance
- Tailor your resume and cover letter to emphasize your skills and qualifications for this specific role
- Prepare examples of how you have handled high-priority complaints and written regulatory reports
ATS Keywords: Medical Device, Vigilance Reporting, Complaint Handling, Quality Assurance, Regulatory Compliance, Data Analysis, Problem Solving, Collaboration, CAPA System, Auditing, Project Management, Detail Oriented, Microsoft Office
ASSUMPTION: Insulet Corporation uses an Applicant Tracking System (ATS) to manage job applications, and including relevant keywords in your resume can help improve your chances of being selected for an interview.
🛠️ Tools & Technologies
- Microsoft Office (Excel, Word, Outlook)
- Complaint database applications (e.g., Medtronic's Global Complaint Management System)
- Regulatory submission tracking tools (e.g., Veeva Vault)
ASSUMPTION: Familiarity with these tools is preferred, but not required, as training will be provided.
👔 Cultural Fit Considerations
Company Values:
- Innovation
- Quality
- Integrity
- Collaboration
- Accountability
Work Style:
- Results-driven
- Team-oriented
- Adaptable and flexible
- Strong attention to detail
- Excellent communication skills
Self-Assessment Questions:
- How have you demonstrated innovation in your previous roles?
- Can you provide an example of a time when you had to collaborate with a team to meet a tight deadline?
- How do you ensure the quality and accuracy of your work, especially when handling sensitive information?
ASSUMPTION: Insulet Corporation values employees who are innovative, quality-focused, and collaborative, with a strong work ethic and a commitment to excellence.
⚠️ Potential Challenges
- Handling high-priority complaints and meeting tight regulatory deadlines
- Working with a diverse, global team and managing different time zones
- Keeping up with changing regulatory requirements and industry trends
- Balancing remote work and maintaining productivity
ASSUMPTION: These challenges can be overcome with strong organizational skills, effective communication, and a commitment to continuous learning and improvement.
📈 Similar Roles Comparison
- This role is similar to a Senior Medical Device Vigilance Reporting Specialist, but with a stronger focus on global regulatory compliance and collaboration with internal teams
- Compared to a Quality Assurance Manager, this role has a more narrow focus on vigilance reporting and complaint handling, but still requires strong quality management system knowledge and experience
- Career progression from this role could lead to a Director or Vice President of Global Product Monitoring and Vigilance position
ASSUMPTION: While this role shares similarities with other medical device vigilance reporting positions, its unique focus on global regulatory compliance and collaboration sets it apart.
📝 Sample Projects
- Developing and implementing a new global vigilance reporting process to improve efficiency and accuracy
- Collaborating with cross-functional teams to investigate and resolve high-priority complaints
- Conducting a comprehensive review of the company's complaint handling processes and making recommendations for improvement
ASSUMPTION: These sample projects demonstrate the range of responsibilities and the level of autonomy and initiative expected in this role.
❓ Key Questions to Ask During Interview
- How does this role fit into the overall global product monitoring and vigilance strategy?
- What are the most challenging aspects of this role, and how have previous incumbents succeeded in overcoming them?
- How does the company support the professional development and growth of its employees in this role?
- What are the key priorities for this role in the first 30, 60, and 90 days?
- How does the company ensure the accuracy and completeness of regulatory submissions, especially when working remotely?
ASSUMPTION: Asking thoughtful, informed questions demonstrates your interest in and understanding of the role and the company.
📌 Next Steps for Applicants
To apply for this position:
- Submit your application through this link
- Tailor your resume and cover letter to highlight your relevant experience and skills for this role
- Prepare examples of how you have handled high-priority complaints and written regulatory reports
- Follow up with the hiring manager one week after submitting your application to express your continued interest in the position
⚠️ This job description contains AI-assisted information. Details should be verified directly with the employer before making decisions.
