Regulatory Affairs Specialist

2 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 have the opportunity to make a meaningful impact in the medical device industry.

About the Role

We're seeking an experienced Associate Regulatory Affairs Specialist to join our team in post-market regulatory product support. In this role, you'll be responsible for:

  • Preparing, executing, and following up on Field Safety Corrective Actions (FSCA) according to our enterprise plan.
  • Collaborating closely with sales managers and representatives to collect and record evidence, ensuring timely closure of UK/Ireland Field Actions.
  • Supporting Post-Market Surveillance activities, 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

To be successful in this role, you'll need:

  • 3-5 years of experience in medical device regulatory, quality, or product-related fields or a related university degree (Regulatory Affairs, Pharmacy, Engineering, or other scientific degree).
  • Advanced computer skills, including Microsoft Office and custom organizational software.
  • Clear communication and proficient English language skills.
  • Quality orientation and patient safety focus, with a curiosity and high interest in the medical device field.
What We Offer

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

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