Senior Global Product Monitoring Vigilance Report Writer (Hybrid - Acton, MA.)

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:

• Hybrid - Acton, MA.
• Primary Job Posting: United States

NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office at least three (3) days per week. #LI-Hybrid

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 i