Manager, Global Vigilance Writing (Remote/Flexible)

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

The Manager of Global Vigilance Writing 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

• Oversee the Global assessment, follow-up, coding, and vigilance activities for complaints determined to be reportable
• Ultimately responsible for oversight, peer review, and approval of vigilance reports to ensure on time submissions to the appropriate regulatory authorities.
• Manage the quarterly periodic summary reporting process
• Oversee the day-to-day vigilance reporting assignment; support management in day-to-day operations in a fast-paced work environment; lead day-to-day operational work distribution and end of day/week/month reconciliation.
• Lead, provide instruction, and feedback to the team as needed.
• 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 departmental non-conformances escalated into CAPA System
• Serve as a subject matter expert for post market and complaint handling regulatory questions and inquiries.
• Understand the principles of scientific writing, writing with the audience in mind, and conveying messages in a clear and concise manner. Analyzes, interprets, and distills data and other information to create vigilance reports.
• Apply comprehensive knowledge of relevant regulatory requirements and corporate policies to assess document requirements and identify information gaps or other potential issues. Takes appropriate risks to resolve any identified issues.
• Lead internal and external audits and inspections.
• Manage special projects as assigned
• Perform other duties as required

Education and Experience:

• Requires a Bachelor’s degree and 5 years of demonstrated experience in medical device complaint evaluation and reportability determination, or 5 years clinical experience in diabetes management or appropriate combination of relevant education and experience
• Prior management experience leading remote teams

Preferred Qualifications:

• 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.
• Strong proficiency in common computer applications such as Microsoft Office (Excel, Word, Outlook) and complaint database applications.
• 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 leadership abilities and coaching for subordinate team members; demonstrated ability to influence without authority.
• Ability to organize, judge priorities, and escalate when applicable.
• Strong emphasis and understanding of a formalized medical device Quality Management System.

Preferred Skills and Competencies:

• 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
• Working knowledge and application of ISO 13485 and FDA 21 CFR Part 803 & 820 quality system requirements and other applicable regulations

Physical Requirements:

• General office environment – may sit for long periods of time.
• This position requires extensive computer use.
• May involve up to 10% travel

Additional Considerations:

• Remote/Flexible
• Primary Job Posting: United States
• Additional Job Posting Locations: France, Germany, United Kingdom
• Willingness to pursue additional learning and build qualifications in a professional field, as required

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). #LI-Remote  

Additional Information:

The US base salary range for this full-time position is $101,500.00 - $152,500.00. 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.