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Senior Global Product Monitoring Vigilance Report Writer (Remote/Flexible)

Insulet Corporation
Full-time
Remote
Worldwide
✍️ Copywriting & Content Writing

πŸ“Œ Core Information

πŸ”Ή Job Title: Senior Global Product Monitoring Vigilance Report Writer (Remote/Flexible)

πŸ”Ή Company: Insulet Corporation

πŸ”Ή Location: United Kingdom, France

πŸ”Ή Job Type: Full-Time

πŸ”Ή Category: Medical Equipment Manufacturing

πŸ”Ή Date Posted: 2025-04-23

πŸ”Ή Experience Level: 5-10 years

πŸ”Ή Remote Status: Remote OK

πŸš€ 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.

πŸ“‹ Key Responsibilities

βœ… Assessing, following up, coding, and vigilance activities for high-priority complaints

βœ… Authoring, peer reviewing, and approving vigilance reports for regulatory submissions

βœ… Supporting management in day-to-day operations and special projects

βœ… Collaborating with internal and external teams to ensure regulatory compliance

βœ… Serving as a subject matter expert for post-market and complaint handling regulatory questions

βœ… Supporting internal and external audits and inspections

βœ… 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.

πŸ’° 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.

πŸ“Œ Applicant Insights

πŸ” 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.

πŸ“Š 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.

πŸ’Ό 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.

πŸ› οΈ 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.

πŸ‘” 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.

πŸ“ˆ 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.

πŸ“ 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.

πŸ“Œ 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.