Regulatory Affairs Executive – Medical Devices

Location: Gloucestershire  |  Gloucestershire  |  England
Sector: Life Sciences
Consultant: Stewart McGrath
Job Reference: HQ564
Salary: £30000 - £35000
Job Status: Permanent / Full Time

JOB TITLE: Regulatory Affairs Executive

LOCATION: Gloucestershire

SALARY: £30 – £35K Per Annum

RESPONSIBILITIES OF THE ROLE:

The role of the RA Executive-  Technical is to undertake the following overall responsibilities:

  • Maintaining and managing Technical Files
  • Obtain and maintain Notified Body CE certification and FDA clearance (510(k))
  • Collate and submit Technical File documentation to the Notified Body
  • Assist the creation and maintenance of DHFs and DMRs
  • Creating and maintaining Essential Requirement / General Safety and Performance Requirement Checklists
  • Act as Regulatory Department representative on the Change Committee
  • Act as Regulatory project leader for new product introduction
  • Ensure the company’s products are in compliance with European and international requirements for biological safety.
  • Creating, updating and reviewing clinical evaluation reports
  • Assist in the interpretation of standard, regulatory and customer requirements for implementation of Quality Documentation/Quality Processes and products
  • Provide support and input into NC/CAPAs, where required
  • Supporting the conducting, planning and reporting of internal quality audits
  • Collating and analyzing data
  • Act as a work stream leader, and team member where required to achieve then maintain compliance to the Medical Device Regulation.
  • Assist in the Regulatory Affairs training and awareness program
  • Assist in the promotion of awareness of the quality culture and customer requirements in the business
  • Support the RA team where required
  • Assist in the implementation of departmental objectives
  • Provide support during audits and inspections
  • Provide training to other team members/colleagues as required.
  • Any other duties as required

QUALIFICATIONS AND EXPERIENCE:

  • A bachelor’s degree in life sciences or engineering, or equivalent
  • Minimum of two years experience in Regulatory Affairs for Medical Devices
  • Maintaining technical files
  • Experience of regulatory submissions
  • Knowledge of international regulatory requirements for medical devices
  • Excellent working knowledge of Microsoft Office (outlook, word and excel)
  • An understanding of Quality Systems is desirable

You will be working alongside the fastest growing recruitment company in the UK, who provide an unrivalled service to all of their clients and candidates across the United Kingdom. Seven currently offer the best contractor pay rates in the UK for Life Sciences, making us the best option for maximising your earning potential and career fulfilment. Seven Consultants are passionate about placing you in the best possible role, for the best possible rate, while providing a support platform, which is accessible around the clock.

Are you ready for the challenge? If so, we look forward to hearing from you.

What else can you expect from Seven?

– Specialist Consultant allocated to you with all the expertise you require.

– Excellent Payroll and Compliance System, ensuring that you are paid on time, every time.

– Access to Exclusive Rates, allowing you to gain earnings that no other agency can offer you.

– £250 Referral Bonus for every person you successfully refer to Seven.

If you are interested in this opportunity, please call 020 3887 7365. Please ask for Stewart McGrath in the Life Sciences team.