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Regulatory Specialist - Remote Working - IVD

  • Standort

    UK

  • Salary

    £35000 - £45000 per annum

  • Sector

    Compliance

  • Job Ref

    87054

  • Contact

    Will Godfrey

  • Published

    etwa 9 Stunden her

Übersicht

Our Client is an inspirational Medical Device business operating in the IVD space that offer a broad range of products across the globe.

Benefits

  • Remote Working

  • 25 days of holiday with options to buy and sell

  • Perkbox discounts, freebies and a birthday box

  • A free health test for you plus discounts to share with family and friends

  • Employee Assistance Programme

  • Online GP access

  • 2 community volunteer days

  • Communication and social events

Job Description

This is a fantastic opportunity for a Regulatory Specialist with IVDR, UKCA and IDU implementation experience to join our client in a fast moving, dynamic environment. The role will work as part of a growing Quality and Regulatory team to provide regulatory support in maintaining and updating Medical Device Technical files. In addition, you will also lead in driving the Post Market Surveillance activities, UKCA, CE marking and UDI projects.

Responsibilities

  • Successfully implement UKCA requirements, including; ensuring all device and package labelling is compliant, and the technical file has been updated to include any UKCA changes.

  • Successful implementation of UDI- to ensure labelling and technical file requirements have been met

  • Post-Market Surveillance - to create a framework for gathering post-market surveillance data for CE marked kits and reporting on PMS data to the QA/RA manager quarterly.

  • ​​Ensuring Technical Files are maintained and updated in line with regulatory changes such as UKCA marking and UDI

  • Responsible for successfully carrying out CE marking and technical file writing in compliance with industry standards to ISO 13485 and ISO 15223 requirements

  • Assess device changes and impact on Technical Files, ensuring Change Control process is followed for technical file revisions

  • Support with the review and development of device packaging, product labelling, product claims and promotional items to ensure all applicable regulatory requirements have been met i.e. ISO 15223, IVDR and ISO 13485 requirements

  • Act as a subject matter expert for device labelling and sharing guidance with teams on requirements

  • Negotiate and interact with regulatory authorities (where required) during the development and review process for CE marking to ensure submission approval.

  • Provide regulatory input with New Product Development

  • Support in internal and third-party audits when required

Required Skills

  • IVDR experience

  • Experience in working with self-test devices such as finger prick lancet, Class I and or Class II. It would also be advantageous if you have experience in working with devices that do not require a notified body

  • Technical writing and amendments

  • UKCA marking

  • Post-Market Surveillance - data gathering and PMS report writing

  • Experience in implamenting UDIs for IVDR compliance

  • Experiences in device labelling reviews and feeding back to the business on regulatory requirements for device labelling

  • EUDAMED registration experience would be advantageous

For immediate consideration please forward your most up to date CV

Austin Fraser is acting as an Employment Agency in relation to this vacancy.

Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.