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Quality & Regulatory Specialist

Premium Job From Real Staffing
Recruiter: Real Staffing
Listed on: 23rd June
Location: Abingdon
Salary/Rate: £40,000 - £45,000
Type: Permanent
Start Date: ASAP

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Our client a medical device company in Oxfordshire are looking for a Quality & Regulatory Associate to join the team. Medical Device Products are certified to CE and ISO standards, and approved by the CSA, FDA, and other agencies. The company are working on notable private and public sector projects to benefit customers and the public.

  • The Quality & Regulatory Associate will support the Manager, Team and Operations in driving manufacturing excellence and cultural change/improvement
  • Make quality decisions on product & quality management systems and to advise on, and assist with hands-on practical operational changes and improvements
  • Monitor and ensure compliance with international Quality and regulatory standards ISO 13485, FDA, MDD 93/42/EC, MDR and other regulated geographies
  • Ensure compliance to all processes related to the requirements of Regulatory Affairs & Quality Management Systems
  • Measure progress and report monthly against quality objectives
  • Maintenance of site and country registrations for applicable products
  • Ensure the promotion of awareness of customer requirements throughout the organisation in adherence with the Quality Policy
  • Provide documentation for product restrictions
  • Produce documentation for on-market changes
  • Manage through to completion the CAPA process
  • Tracking regulatory changes (standards / directives)
  • When required provide support to MDR and vigilance reporting
  • Support to the Product field corrective actions and product risk management processes.
  • Provide regulatory input to the post market surveillance system to meet regulatory requirements & contribute to same
  • Assist in external audits
  • Participate as an auditor in the internal audit process of the company's quality system
  • Where appropriate, provide QA and/or RA requirements and approvals into the design and change control process
  • If and when required - Assist in the developing and conducting internal and external training
  • Ensure compliance with the Company Health and Safety Policy

Qualifications:

  • Ideally degree level education or equivalent experience in a hands on role
  • Quality and/or Regulatory knowledge
  • Medical Devices or Life Sciences experience
  • Although the list above is detailed applicants from Quality or Regulatory backgrounds are encouraged to apply as development opportunity is on offer if anything is lacking

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales