📌 Core Information
🔹 Job Title: Senior Global Product Monitoring Vigilance Report Writer (Remote/Flexible)
🔹 Company: Insulet Corporation
🔹 Location: United States - Massachusetts
🔹 Job Type: Full-Time
🔹 Category: Medical Equipment Manufacturing
🔹 Date Posted: 2025-04-22
🔹 Experience Level: 5-10 years
🔹 Remote Status: Remote OK
🚀 Job Overview
Key aspects of this role include:
- Developing and maintaining quality assurance methodologies
- Serving as a post-market vigilance and surveillance subject matter expert
- Collaborating with internal teams to ensure regulatory compliance
- Supporting management in day-to-day operations in a fast-paced environment
- Leading or contributing to departmental non-conformances escalated into CAPA System
ASSUMPTION: This role requires a high level of autonomy and strong organizational skills to manage multiple tasks and projects simultaneously.
📋 Key Responsibilities
✅ Responsible for the assessment, follow-up, coding, and vigilance activities for complaints determined to be High-Priority for the US FDA and other countries.
✅ Author, peer review, and approve vigilance reports to ensure on time submissions to the appropriate regulatory authorities.
✅ Support management in day-to-day operations in a fast-paced work environment; Support proper coding of complaints and reportable events.
✅ Collaborate with engineering, complaint investigation laboratory, medical and other internal staff as applicable to review events, coding, and investigation results to support regulatory reporting compliance occurs per procedures, standards, and regulations.
✅ Lead or contribute to departmental non-conformances escalated into CAPA System
✅ Serve as a subject matter expert for post-market and complaint handling regulatory questions and inquiries.
✅ Support internal and external audits and inspections.
✅ Assist with special projects, as assigned, with minimal supervision.
✅ Perform other duties as required.
ASSUMPTION: This role involves handling sensitive information and requires a high degree 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 clinical experience in diabetes disease management or diabetes device support or appropriate combination of relevant education and experience.
Required Skills:
- Proven medical device complaint handling and vigilance reporting experience
- Strong analytical skills and attention to detail
- Effective verbal and written communication skills
- Ability to organize, judge priorities, and escalate when applicable
- Strong proficiency in common computer applications such as Microsoft Office (Excel, Word, Outlook) and complaint database applications
Preferred Skills:
- Demonstrated medical device complaint handling and vigilance reporting experience
- Working knowledge/experience with global, multi-country vigilance reporting requirements for medical devices and demonstrated knowledge of country-specific differences and requirements
- Direct experience of 5 or more years in writing and filing global vigilance reports within the medical device industry
- Experience in dealing directly with regulatory bodies
- BSN with diabetes experience, Registered or Licensed Dietician or Diabetic Educator, preferred
- Strong emphasis and understanding of a formalized medical device Quality Management System
- Demonstrated ability to influence without authority
ASSUMPTION: While a Bachelor's degree is required, relevant experience in the medical device industry or clinical setting may be considered equivalent.
💰 Compensation & Benefits
Salary Range: $84,975.00 - $127,462.50 USD per year
Benefits:
- Health, dental, and vision insurance
- 401(k) plan with company match
- Paid time off (vacation, sick, and holidays)
- Employee assistance program
- Tuition reimbursement
Working Hours: Full-time, typically 40 hours per week, with flexibility for remote work
ASSUMPTION: The salary range provided is an estimate based on industry standards for similar roles and may vary depending on the candidate's experience and qualifications.
📌 Applicant Insights
🔍 Company Context
Industry: Medical Equipment Manufacturing, specifically focused on diabetic management devices
Company Size: 1,001-5,000 employees, providing a mid-sized company environment with opportunities for growth and collaboration
Founded: 2000, with over two decades of experience in the medical device industry
Company Description:
- Innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform
- Offers a unique alternative to traditional insulin delivery methods with its tubeless, wearable Pod design
- Provides automated insulin delivery systems that integrate with continuous glucose monitors
- Operates globally, with products available in 25 countries
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 focus on innovation and improving the lives of people with diabetes.
📊 Role Analysis
Career Level: Mid-level to senior, with opportunities for growth and advancement within the quality and regulatory departments
Reporting Structure: This role reports directly to the Manager of Global Product Monitoring and may have supervisory responsibilities for junior team members
Work Arrangement: Remote OK, with the option to work from home or in a hybrid on-site/virtual arrangement
Growth Opportunities:
- Advancement within the quality and regulatory departments
- Expansion of responsibilities to include additional therapeutic areas
- Potential to work on special projects and initiatives
ASSUMPTION: This role offers opportunities for professional growth and development within a dynamic and innovative company.
🌍 Location & Work Environment
Office Type: Hybrid, with the option to work on-site or remotely
Office Location(s): Acton, Massachusetts (headquarters), with additional offices in London, England; Oakville, Ontario, Canada; and San Diego, California, USA
Geographic Context:
- Acton, Massachusetts is located approximately 20 miles northwest of Boston, offering a suburban environment with easy access to urban amenities
- The area provides a mix of cultural, recreational, and educational opportunities
- Massachusetts is known for its robust healthcare industry, providing ample networking and career growth opportunities
Work Schedule: Full-time, typically 40 hours per week, with flexibility for remote work
ASSUMPTION: The work environment is fast-paced and collaborative, with a strong emphasis on regulatory compliance and quality assurance.
💼 Interview & Application Insights
Typical Process:
- Phone or video screen with the Talent Acquisition team
- Technical interview with the hiring manager or a member of the quality and regulatory team
- Final interview with the Director of Global Product Monitoring or another senior leader
Key Assessment Areas:
- Technical knowledge of medical device complaint handling and vigilance reporting
- Problem-solving skills and ability to work independently
- Attention to detail and strong organizational skills
- Effective communication and collaboration skills
Application Tips:
- Highlight relevant experience in medical device complaint handling and vigilance reporting
- Tailor your resume to emphasize skills and experiences related to the key responsibilities and required qualifications
- Prepare for behavioral interview questions that focus on problem-solving, collaboration, and attention to detail
- Research Insulet Corporation and the medical device industry to demonstrate your enthusiasm and understanding of the role
ATS Keywords: Medical device complaint handling, vigilance reporting, regulatory compliance, quality management system, analytical skills, detail oriented, interpersonal skills, effective communication, complaint investigation, coding of complaints, post-market surveillance, CAPA system, collaboration, project management, computer proficiency, subject matter expertise
ASSUMPTION: The application process may involve multiple rounds of interviews and assessments to ensure the best fit for the role and the company.
🛠️ Tools & Technologies
- Microsoft Office Suite (Excel, Word, Outlook)
- Complaint database applications (e.g., Medtronic's Global Complaint Management System, BD's Complaint Management System)
- Regulatory reporting software (e.g., FDA's Electronic Submissions Gateway, EudraVigilance)
ASSUMPTION: The specific tools and technologies used may vary depending on the company's internal systems and processes.
👔 Cultural Fit Considerations
Company Values:
- Innovation: We foster a culture of creativity and continuous improvement
- Patient-Centered: We prioritize the needs and well-being of the patients we serve
- Collaboration: We work together to achieve our goals and drive success
- Accountability: We take ownership of our responsibilities and hold ourselves to the highest standards
- Integrity: We act with honesty and transparency in all our interactions
Work Style:
- Fast-paced and dynamic environment
- Strong emphasis on regulatory compliance and quality assurance
- Collaborative and cross-functional teamwork
- Opportunities for professional growth and development
Self-Assessment Questions:
- How do you stay organized and manage multiple tasks and projects simultaneously?
- Can you provide an example of a time when you had to handle sensitive information with a high degree of confidentiality and attention to detail?
- How do you approach working in a fast-paced and dynamic environment?
ASSUMPTION: Insulet Corporation values a diverse and inclusive work environment, and encourages applicants from all backgrounds to apply.
⚠️ Potential Challenges
- Handling a high volume of complaints and reportable events in a timely manner
- Navigating complex regulatory requirements and guidelines
- Managing multiple projects and priorities in a fast-paced environment
- Working with sensitive and confidential information
ASSUMPTION: These challenges can be overcome with strong organizational skills, attention to detail, and a commitment to regulatory compliance and quality assurance.
📈 Similar Roles Comparison
- This role is similar to a Senior Medical Device Vigilance Specialist or a Senior Global Product Safety & Vigilance Manager, but with a stronger focus on complaint handling and regulatory reporting
- Insulet Corporation is a mid-sized company, offering a more collaborative and agile work environment compared to larger enterprises, but with fewer resources and potentially less structured career paths
- This role offers opportunities for professional growth and development within the quality and regulatory departments, with the potential to expand responsibilities to include additional therapeutic areas
ASSUMPTION: The specific responsibilities and career paths for similar roles may vary depending on the company's size, industry, and internal structure.
📝 Sample Projects
- Leading a project to streamline the complaint handling and reporting process, resulting in a 20% reduction in turnaround time
- Collaborating with cross-functional teams to develop and implement a global vigilance reporting system, ensuring compliance with regional regulatory requirements
- Conducting a comprehensive review of the company's quality management system and making recommendations for improvement
ASSUMPTION: These sample projects demonstrate the role's focus on regulatory compliance, quality assurance, and process improvement.
❓ Key Questions to Ask During Interview
- Can you describe the team structure and dynamics within the quality and regulatory departments?
- How does the company support the professional development and growth of its employees?
- What are the key priorities and initiatives for the quality and regulatory departments in the next 6-12 months?
- How does the company ensure the accuracy and completeness of regulatory submissions?
- What is the company's approach to work-life balance and employee well-being?
ASSUMPTION: These questions demonstrate your interest in the role, the company, and the industry, and help you assess the fit between your skills, experiences, and the organization's needs.
📌 Next Steps for Applicants
To apply for this position:
- Submit your application through the Insulet Corporation careers website
- Tailor your resume to highlight relevant experience in medical device complaint handling and vigilance reporting, as well as skills related to the key responsibilities and required qualifications
- Prepare a cover letter that explains your interest in the role and the company, and how your skills and experiences make you a strong fit for the position
- If applicable, prepare examples or a portfolio that demonstrates your experience with medical device complaint handling, vigilance reporting, and regulatory compliance
- Follow up with the Talent Acquisition team one week after submitting your application to inquire about the status of your application
⚠️ This job description contains AI-assisted information. Details should be verified directly with the employer before making decisions.
