Quality Assurance and Regulatory Affairs Specialist

Location: Southampton, Hampshire Salary: £35000 - £45000 per annum
Sector: Medical Devices Type: Permanent
Contact: Matt Henocq Job Published: 22 days ago

Quality Assurance and Regulatory Affairs Specialist

My client is a leading manufacturer of medical healthcare equipment. The are looking for a qulaity assurance and regulatory affairs specialist to join their team in Southampton. You will be responsible for my clients healthcare products issueing they comform to current regulatory standards for medical devices.

Managing and coordinating all the product technical files and relevant quality processes, you will maintain the current ISO 13485:2016 certificate and manage the internal audits for the company's Quality Managers Systems and compliance schemes. This role will be in control of issuing Medical Device Alerts (MDA) and Field Safety Notices (FSN) with input from the Medicines & Healthcare Products Regulatory Agency (MHRA) as required. You will act as the specialist advisor within Ultimate Healthcare in the product development cycle and to champion quality assurance and regulatory compliance.

All of their products must be registered with the MHRA ensuring these products and documented processes meet the required standards and regulations. This will involve updating and amending documentation and liaising with external governance bodies as required. You will raise non-conformance reports and undertake/initiate any actions highlighted from these.

Required qualities and experiences:

  • Proven experience in managing products and processes to Medical Device Directive (MDD) and Medical Device Regulation (MDR)
  • Expertise of ISO 13485, ISO 9001
  • Ideal candidate will have formal qualifications in MDD/MDR compliance and ISO 13485 Lead Auditor qualification (desirable)
  • Strong manufacturing background and experience in a similar role/environment
  • Excellent verbal and written communication skills
  • Extremely confident at delivering training to all levels of employees
  • Proven team player with the ability to use own initiative
  • Highly proficient in the use of IT software including PowerPoint, Word, Excel, simple databases
  • Ability to achieve deadlines and adhere to audit schedules

Services advertised by Gold Group are those of an Agency and/or an Employment Business.
We will contact you within the next 14 days if you are selected for interview. Privacy Policy. Equal Opportunity and Diversity Policy.

Similar Jobs

Regulatory Manager

Leeds, West Yorkshire £40000 - £50000 per annum

Regulatory Manager My client is a leading UK manufacturer of meedical devices for minimally invasive surgery. Alongside their own products my cleint is proud to work with other leading medical device companies on an OEM basis to design and manufacture medical devices...


Clinical Research Monitor

Leeds, West Yorkshire £30.00 - £40.00 per hour

Summary of position: Provide support to the implementation of the clinical research operations programme for all appropriate therapeutic areas for my clients Medical Devices in accordance with all applicable regulations for Medical Devices. Plan & implement a program...


Clinical Trail Leader

Leeds, West Yorkshire £50.00 - £57.00 per hour

Clinical Trail Leader My client is at the forefront of technology in the medical device industry. This position is to serve as a Clinical Trial Leader within Clinical and Medical Strategic Operations to execute company sponsored clinical trail for my client medical d...