Regulatory Affairs Specialist

☞ Martin Anthony

View: 107

Update day: 11-06-2024

Location: Warrington North West

Category: Legal / Contracts

Industry: Electrical Electronic Manufacturing Automotive Mechanical or Industrial Engineering

Position: Entry level

Job type: Full-time

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Job content

Job Title: Regulatory Affairs Specialist Salary: Negotiable depending on experience, plus benefits Location: Warrington area Specialist recruiter MARTIN ANTHONY, has been assigned by a leading UK manufacturer of world-class products. They are currently experiencing a huge demand for their range of products and are investing heavily in their UK manufacturing facilities to meet demand. The company are financially secure and well positioned to continually deliver innovative products and solutions. A fantastic opportunity has arisen to strengthen the business with the appointment of a Regulatory Affairs Specialist. As the Regulatory Affairs Specialist, you will be responsible for compiling and managing the technical files for our client’s range of products. This role will see you take full responsibility for all medical devices made in their factories My client requires a hands-on approach to ensuring all devices meet the required standards and the relevant parts of the Medical Device Regulation. Key Responsibilities:
  • Responsibility for all medical devices coming out of UK manufacturing sites as well as products which are sourced.
  • Maintaining current compliance of all medical devices
  • Ensuring all product types are listed on the MHRA website
  • Primary contact for Certification Bodies for product certification
  • Primary contact for test laboratories to arrange the relevant testing.
  • Communicating with Senior Management on all regulatory issues relating to the Medical Devices
  • Validating and approving suppliers
  • Responsible for collating all data for technical files including ensuring clinical evaluations are processed, risk assessments completed as well as all other items.
  • Collating data for the management review for ISO13485
  • Involvement in customer complaints relating to non-conforming product
  • Working closely with Production to ensure product is compliant
  • Enabler for change and dissemination of good practice Desired Skills and Experience required:
  • A good level of education within a relevant field or equivalent experience
  • Experienced regulatory professional with working knowledge of the MDD / MDR
  • Experience of working in a manufacturing environment
  • Experience in dealing with MHRA and FDA for approvals
  • Knowledge of ISO13485
  • Excellent interpersonal skills
  • Methodical with great attention to detail
  • Excellent problem-solving and decision-making skills
  • Ability to work well under pressure and to tight deadlines This is a job that will either suit someone who has some relevant experience within the field of regulatory affairs for medical devices and is looking for a Manager who can help them reach their full potential, or a more established specialist that wants to develop their career and a team of as the department grows. To apply, please email a copy of your most up to date CV to MARTIN ANTHONY or call for more details. Please note – MARTIN ANTHONY are currently experiencing a large volume of applications, so if you don’t hear from us within 2 weeks, then unfortunately your application has been unsuccessful on this occasion
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    Deadline: 26-07-2024

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