Regulatory Affairs and Compliance

Location: Newmarket
Sector: Technical & Engineering
Job type: Full Time, Permanent
Hours: 40 hours a week, Monday – Friday with flexible start and finish times
Reward: £40,000 plus depending on experience
Start: ASAP

We are currently recruiting for a Regulatory affairs and compliance specialist to join a unique and growing company. You will be working alongside the Regulatory team working on multiple projects preparing documents for regulatory submissions and communicating with relevant regulatory authorities across the EU and globally. To be suitable for the position you must have and Engineering background with previous experience working within the medical device industry.

Due to the clients location you must have a full driving licence.

Duties:

  • Working closely with the Research and development team to design assurance documentation and support with current regulatory information
  • Working on multiple projects and producing risk analysis and FMEA reports for these projects
  • Preparing documents for regulatory submissions and communicate with regulatory authorities within the EU and globally
  • Assisting with clinical evaluation and post market surveillance with devices on the market
  • Keeping the documentation and system up to date
  • Ensuring you are constantly updating yourself with any changes to regulatory procedures and providing advice for regulatory strategy for new products, product improvements and process changes
  • Attend site meetings, events and consultations

Essential Skills/Experience/Education:

  • Minimum of 2 years experience in regulatory affairs role within the medical device Industry
  • Must have an Engineering background and be passionate about the industry
  • Ideally have a degree within Engineering, Scientific or relevant life science
  • Experience working within an ISO 13285 2016 QMS System
  • In depth knowledge of ISO 13485 design and development assurance
  • Methodical thinker and Problem Solver
  • Able to work to targets and meet deadlines
  • Excellent communications skills internally with colleagues and externally with clients

If you have not received a response within 3-5 working days, unfortunately your application has been unsuccessful. Busy Bee Recruitment Ltd is acting as an Employment Business for this Permanent vacancy.

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