Global Medical Device Compliance Specialist

2 dagen geleden

Utrecht, Utrecht, Nederland ViCentra Voltijd
About Vi Centra

Vi Centra is a pioneering company in the medical device industry, dedicated to designing innovative products that empower people with diabetes to manage their condition effectively. With over 30 million insulin-dependent individuals worldwide, Vi Centra aims to revolutionize the way we approach diabetes management.

We are currently seeking a Senior Post-Market Surveillance Specialist to join our team of passionate professionals. This role offers a unique opportunity to work on a groundbreaking new product and contribute to the development of our cutting-edge insulin pump, Kaleido.

The Opportunity

As a Senior Post-Market Surveillance Specialist, you will play a critical role in ensuring compliance with regulatory requirements, such as EU MDR and FDA guidelines. You will lead post-market activities, provide extensive regulatory affairs support to project teams, and contribute to other regulatory initiatives as needed.

Main Responsibilities:
  • Plan, conduct, and report on post-market surveillance activities to support Vi Centra's manufacturer obligations under the MDR, FDA, and other applicable regulatory requirements.
  • Triage complaints on reportability in accordance with specific regulations and report these complaints to applicable authorities, including follow-ups.
  • Report and maintain communication with authorities on a timely manner.
  • Provide analysis and reporting of complaint data, enabling timely and informed decisions relating to product safety, quality, and customer satisfaction.
  • Prepare Health Hazard Evaluation (HHE), corrections, and field safety corrective actions documents.
  • Lead/support Field Action assessments and executions when needed.
  • Compile databases of research.
  • Review promotional and advertising materials, complaints, and lead vigilance and MDR reporting efforts.
  • Achieve goals by accepting ownership; exploring opportunities to add value to job accomplishments.
Requirements:
  • Education: Degree in a technical/scientific field or equivalent experience.
  • Experience: Minimal 5 years working experience with complaint handling, vigilance, and field safety corrective actions in the medical device industry.
  • Rich experience in the field of complaint handling and vigilance activities in a medical device environment, e.g., experience in medical QMS (e.g., ISO 13485).
  • Strong analytical and reporting experience.
  • Proven ability to work independently, prioritize multiple projects, address multiple issues in a hands-on, timeline-driven environment.
  • Strong professional ethics and integrity, sound judgment, and the ability to take decisive action.
  • Knowledge of global Medical Device Regulations (EU MDR and FDA), particularly in relation to complaint handling and adverse events.
  • Pragmatic, accurate, analytical, enjoying a mix of activities in regulatory and clinical challenges.
  • Working knowledge of medical device regulations, requirements, and standards, including 21 CFR 820, ISO 13485, ISO 14971, 2017/745, and EEC 93/42.
  • Strong IT skills, including but not limited to MS Office (advanced user).
What We Offer

As a valued member of our team, you will enjoy a competitive salary of €60,000 - €80,000 per annum, plus an additional 8% holiday allowance. Our benefits package includes:

  • 25 days of holiday per year, plus the opportunity to take Dutch national holidays on any day that suits you.
  • Flexible working hours and hybrid working options to divide your time between working from the office and working from home.
  • A partially company-subsidized pension scheme.
  • Subsidized gym membership and the opportunity to participate in a tax-friendly bike scheme.
  • A work environment where you can develop your skills, learn from the best, and be rewarded for your imagination.
  • Mechanical interesting work with the opportunity to make a difference in the lives of people with diabetes.

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