QA/RA Specialist

This role will cover all aspects of quality and regulatory activities at an exciting time for the company as the product portfolio broadens. The role involves working directly with the HL Healthcare Quality Management System and related Technical Files and being actively involved in its upkeep and evolution. The ideal candidate will have experience working within a ISO13485 quality management framework for the design and development of medical devices and have a positive and motivated attitude towards, and being involved in, planning and implementation of projects.

Position Overview

HL Healthcare Ltd
Reports to
Technical Manager, Quality & Regulatory
Working hours
Full time

What’s on offer:

  • Competitive salary
  • Pension
  • Healthcare
  • Company bonus

Key Duties and Responsibilities

  • Assist the Technical Manager with the implementation of regulatory aspects of the HL Healthcare Quality Management System
  • Maintenance of Technical Documentation to meet UKMDR and EUMDR.
  • Post market surveillance requirements in accordance with EUMDR including complaint handling and vigilance activities.
  • Risk management activities in accordance with ISO14971
  • Maintenance of medical device registrations with MHRA, EUDAMED and managing communications with the wider supply network.
  • Support with the activities of United Kingdom Responsible Person duties (UKRP)
  • Creation and maintenance of regulatory intelligence programme

Role Requirements

  • Degree in Life Sciences required
  • ISO13485 QMS experienced required
  • ISO14971 risk management experience required
  • Post Market Surveillance experience required
  • Knowledge of EUMDR required
  • Substance-based medical device experience preferred
  • Auditor training preferred
  • Organised and able to prioritise work
  • Motivational, pragmatic approach

Environment and Culture

VLG is a fast-paced, determined, and agile business. Commercially led, the current structure of our teams enables quick decision-making and the opportunity to work within a broad and varied remit.

Our culture gives our people the opportunity to influence and collaborate in a friendly and open environment. We also recognise and develop potential within our teams.

We look for the following interpersonal skills in our people which demonstrate behaviours representing our values of partnership, empowerment, precision, and potential:

  • Customer focussed – We recognise that our customers are key to our success
  • Innovation – We like our employees to seek out better ways of working
  • Strong decision-making capabilities – Ability to meet multiple demands and be deadline-driven
  • An active listener – Using coaching and mentoring as a preferred style of managing
  • Committed to developing their team – and the wider business, capable of and willing to participate in continuous learning
  • Competent at managing change – independently and at a team level
  • Willing to “pitch in” – getting involved at all levels
  • Ambassadors – To be always ambassadors of VLG
  • Able to work under pressure – and maintain a positive manner

All employees have a responsibility for ensuring they undertake their duties in full accordance with the company’s policies and procedures.

This job description is intended to be a general guide to the duties relevant to the role and will change from time to time so should not be seen as an exhaustive specification.

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