Reporting to the Quality and Regulatory Manager, the Regulatory Assistant will carry out the following tasks:

  • Prepare and update CE technical documents for existing devices in-line with MDR requirements
  • Collaborate with multifunctional teams to provide regulatory support for projects, product labelling and applications to regulatory authorities and notified bodies
  • Assist in monitoring and reporting post-market activities of devices as per MDR requirements
  • Support registration activities and regulatory submissions in international markets

Essential requirements:

  • Excellent written and verbal communication skills
  • Regulatory affairs experience
  • Experience in technical writing and report writing
  • Have a positive ‘can do’ attitude
  • A systematic and methodical approach to their work
  • Excellent accuracy and attention to detail
  • Capable of working on multiple projects, both independently and in a team environment
  • Ability to critically evaluate and summarise complex data into simple messages and actions
  • Prepared to build networks and alliances with peers and external partners

Desirable requirements:

  • A degree in a relevant scientific discipline, or equivalent experience

Our offering:

  • Competitive salary of up to £23,000 depending on experience
  • 27 days holiday
  • Annual bonus
  • Flexible working
  • Health cash plan
  • Pension
  • Perkbox
  • Cycle to Work scheme
  • Free onsite parking

 

Optimum Medical can offer you an environment geared towards performance, attractive career opportunities, and an open culture that values and rewards the contribution of every individual.

 

Our Values:

Potential candidates will be assessed against our company values to make sure you are the right fit for the business.

 

At Optimum Medical we LISTEN, we CREATE, we MAKE IT HAPPEN, we CARE and we HAVE FUN!

 

 

Constantly creating better