|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
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