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

Insulet Corporation; Massachusetts; Hybrid; USD 84,000 - 128,000; Full time

Job summary

An innovative medical device company is seeking a Senior Global Product Monitoring Vigilance Report Writer to enhance quality assurance methodologies and regulatory compliance. This pivotal role involves assessing and coding complaints, authoring vigilance reports, and collaborating with internal teams to ensure adherence to industry standards. The position offers the flexibility of remote work, allowing you to contribute meaningfully to improving patient care in the diabetes management space. Join a forward-thinking organization where your expertise will directly impact the quality and safety of medical devices.

Qualifications

• 5 years of experience in medical device complaint triage and vigilance reporting.
• Demonstrated ability to influence without authority and manage priorities.

Responsibilities

• Assess and follow-up on high-priority complaints for regulatory authorities.
• Author and approve vigilance reports for timely submissions.

Skills

Medical Device Complaint Handling

Vigilance Reporting

Regulatory Compliance

Analytical Skills

Communication Skills

Education

Bachelor's Degree

Tools

Microsoft Office

Complaint Database Applications

Job description

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

Join to apply for the Senior Global Product Monitoring Vigilance Report Writer (Remote / Flexible) role at Insulet Corporation

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

Join to apply for the Senior Global Product Monitoring Vigilance Report Writer (Remote / Flexible) role at Insulet Corporation

The Senior Global Product Monitoring Vigilance Report Writer develops, establishes, and maintains quality assurance methodologies, systems, and medical device industry best practices which meet customer, regulatory, and client requirements; serves as a post-market vigilance (reportable event) and surveillance subject matter expert and representative to improve awareness, visibility, and communication on quality/compliance initiatives to support departmental, divisional, and corporate quality goals and priorities; works on problems of diverse scope where analysis of data requires evaluation of identifiable factors; demonstrates good judgment in selecting methods and techniques for obtaining solutions; and networks with senior internal and/or external personnel in own area of expertise.

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.
  
  

Minimum Qualifications

• Bachelor’s degree and 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.
  
  

Preferred Skills And Competencies

• 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 is highly desired.
• BSN with diabetes experience, Registered or Licensed Dietician or Diabetic Educator, preferred.
• Strong emphasis and understanding of a formalized medical device Quality Management System.
• Effective verbal and written communication skills.
• Ability to generate, verify, and maintain accurate records.
• Must have analytical skills, be detail oriented, and have good interpersonal skills.
• Demonstrated ability to influence without authority.
• 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.
  
  

Physical Requirements

• General office environment – may sit for long periods of time.
• This position requires extensive computer use.
  
  

Additional Considerations

• Remote/Flexible
• Primary Job Posting: United States
  
  

NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired).

Additional Information

The US base salary range for this full-time position is $84,975.00 - $127,462.50. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.

We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Information Technology

• Industries

  Medical Equipment Manufacturing

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