Regulatory Affairs Specialist

3 weeks ago

Watford, Hertfordshire, United Kingdom Medtronic Full time
Unlock Your Potential at Medtronic

At Medtronic, we're driven by a passion to alleviate pain, restore health, and extend life. As a key member of our team, you'll play a vital role in championing healthcare access and equity for all.

About the Role

We're seeking an experienced Associate Regulatory Affairs Specialist to join our team. In this role, you'll be responsible for post-market regulatory product support, including field safety corrective actions, competent authority requests for information, complaint process support, product documentation, and support requests from customers, sales, and tenders teams.

Key Responsibilities
  • Prepare, execute, and follow up on FSCA (Field Safety Corrective Actions) according to the enterprise plan.
  • Collaborate closely with sales managers and sales representatives to collect and record evidence, ensuring timely closure of UK/Ireland Field Actions.
  • Support Post-Market Surveillance by providing advice to sales team members on product complaint handling processes and returns, ensuring compliance with UK/Ireland Regulations and Medtronic procedures.
  • Sourcing, verifying, and providing regulatory documents to customers and other stakeholders.
  • Connecting requests to the appropriate Organizational Unit and ensuring complete follow-up.
Requirements
  • 3-5 years of medical device regulatory, quality, or product-related experience or a related university degree (Regulatory Affairs, Pharmacy, Engineering, or other scientific degree).
  • Advanced computer skills, including Microsoft Office and the ability to use custom organizational software.
  • Clear communication and proficient English language.
  • Quality orientation and patient safety focus, curiosity, and high interest in the medical device field.
What We Offer

Medtronic offers a competitive salary and flexible benefits package. Our mission to alleviate pain, restore health, and extend life unites a global team of 90,000+ passionate people. We're engineers at heart, putting ambitious ideas to work to generate real solutions for real people.

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