Senior Global Product Monitoring Vigilance Report Writer (Hybrid - San Diego, CA)

Insulet Corporation-posted 3 months ago
$93,450 - $140,175/Yr
Full-time • Senior
Hybrid • San Diego, CA
Miscellaneous Manufacturing
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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.

  • 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.
  • Bachelor's degree and demonstrated experience in medical device complaint triage and vigilance reporting or clinical experience in diabetes disease management or diabetes device support or appropriate combination of relevant education and experience preferred.
  • 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 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.
  • The US base salary range for this full-time position is $93,450.00 - $140,175.00.
  • Compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.
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