Associate Regulatory Affairs Specialist

at  Medtronic

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A DAY IN THE LIFE

Medtronic is among the largest medical technology companies in the world. Through innovation and collaboration, Medtronic helps to alleviate pain, restore health and extend life. Last year, our medical therapies for the treatment of over 40 major conditions, improved the lives of more than 75 million people around the world.
We are looking for an experienced Associate Regulatory Affairs Specialist 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, and other internal stakeholders. You will get benefit of hybrid work - Tuesdays and Wednesdays from Watford, UK office and the rest of the week from home.

REQUIRED KNOWLEDGE AND EXPERIENCE:

• 3-5 years of medical device regulatory, quality or product related experience or related university degree (Regulatory Affairs, Pharmacy, Engineering or other scientific degree).
• Advanced computer skills (Microsoft Office including advanced Excel skills and ability to use custom organizational software)
• Autonomy and proactivity, continuous learning, attention to detail
• Organizational and strong administrative skills
• Clear communication, proficient English language
• Quality orientation and patient safety focused, curiosity and high interest in medical device field

PHYSICAL JOB REQUIREMENTS

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

• Preparation, execution and follow up of FSCA (Field safety corrective actions) according to the enterprise plan. Close collaboration with the sales managers and sales representatives to collect/records evidence, allowing timely closure of the UK/Ireland Field Actions. Reconciliation activities in collaboration with the FCA Support Team.
• Follow up on inquiries from the Competent Authority to i.e., Field Action or Vigilance activities. This includes updating the Medtronic reporting systems and record keeping.
• Support on Post-Market Surveillance - provide advice to sales team members on product complaint handling processes and returns, to assure compliance to UK/Ireland Regulations and Medtronic procedures
• Monitors the shared mailbox by providing support to tender requests, customer requests, internal stakeholder requests
• Sourcing, verifying and providing regulatory documents to customers and other stakeholders
• Connecting requests to the appropriate Organizational Unit and ensuring complete follow up
• Maintaining training completion, participation in team and process improvement initiatives