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Job Information

Regulatory Affairs Associate (Registrations)

Information About this Role

Job Summary

Job Title: Regulatory Affairs Associate (Registrations)

Location: Gloucestershire

Industry: Medical Devices

Job Type: Permanent

Salary: £20-25K, pension, healthcare and further benefits

Company Description

This is a fantastic opportunity to start a specialist career path as a Regulatory Affairs Associate for an international medical devices company and to work on specialist Class III Medical Devices.

Our client have been established for over 30 years and are a provider of an exciting range of products and services to healthcare providers and patients; focusing on reconstruction, theatre accessories and infection control. Our client have grown to become a renowned leader within these markets.

You will be working in great facilities and a stunning region within the UK for a great work life balance.

Looking for an exciting and rewarding career? This is a great time platform to kick start a career in Medical Device Regulatory Affairs with an international organisation who retain a close knit team culture. As a Regulatory Affairs Associate you will be joining an experienced and dynamic team of Regulatory and Quality professionals.

There's never been a better time to start! The RAQA department is in the middle of exciting new projects as the company expand their product portfolio internationally across numerous markets.

You will be enjoying the variety of international markets and regulations whilst testing yourself within Class III medical devices.

The company provide comprehensive inductions, training and development programmes harnessed by a strong team ethic and support.

Duties and Responsibilities of the Regulatory Affairs Associate (Registrations):

  • Support global registration and re-registration of all medical devices.
  • Monitoring, analysing and sharing of Regulatory Intelligence and current affairs that affect the company's devices.
  • Building to be a registration expert in time.
  • Execute and follow up on the agreed actions for the registration of products (UK, EU and ROW) where appropriate.
  • Work within the agreed processes, SOPs and time frames set for the project as a whole and on an individual basis.
  • Supporting the Group RA/QMS manager in design and delivery of internal QMS processes, labeling and training programmes.

Experience and Knowledge Required:

  • Science or Engineering degree.
  • 2+ years' of work experience required in a structured process driven role- working on projects (regulatory type projects will be an advantage)
  • Experience in performing Gap analysis
  • Some exposure to medical devices industry
  • Regulatory affairs /Regulatory Compliance experience desirable
  • Training in Quality or Regulatory related fields would be advantageous

Projectus Consulting

Projectus Consulting are a leading Medical Device Recruitment Consultancy. We're a niche business who provide a highly specialist service to both employers and candidates in the Medical Technology Sector.

We are dedicated to finding the right opportunity for you.

Web: www.projectusconsulting.com

LinkedIn: http://linkd.in/1SgKtH3

Twitter: @projectusjobs