Regulatory Specialist - Post Market Surveillance

☞ Indo Professionals

View: 102

Update day: 07-05-2024

Location: Hook South East

Category: High Technology Mechanical / Technical Electrical / Electronics Production / Operation

Industry: Medical Devices

Position: Associate

Job type: Full-time

Salary: £35,000/yr - £45,000/yr

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Job content

Regulatory Specialist – Post Market Surveillance

North Hampshire, UK – 2 to 3 days from home/office-based (applicants must be based in the UK)

Permanent role

Circa £40,000 per annum plus bonus, pension, private medical

Our client is an established, global medical device company supporting the respiratory needs of patients at every stage of life with their pioneering technology.

They are a world-class medical device developer that has seen huge demand for their product range which includes ventilators used in Covid Intensive Care Units (ICU) globally.

Due to the increase in demand, they have created a new position for a Regulatory Specialist (PMS) to be based in their international office in North Hampshire with 2/3 days home working offered.

This is an exciting time to be joining a global Med-Tech within their growing international division. Our client offers a stable platform with flexible working conditions and a progressive, career-enhancing job role.

Please apply today or contact Josh Craven today for more information. josh@indoprofessionals.co.uk / 07929235128

Job role focus;

Working with the Regulatory Manager, the focus of this RA Specialist (PMS) role is to support the management of the compliance of the company and products to relevant regulations and standards encompassing a range of medical device products (Class IIa/B and III). Furthermore, this person will be supporting in the responsibility for Importer and Distributor obligations under the EU MDR along with assisting in QA documentation development & QMS maintenance as well as UKRP obligations.

Key responsibilities include;

· Ensuring medical device regulatory compliance under EU MDR

· liaising with local distributors ensuring verification process and supply chain throughout global geographic locations

· Writing and updating quality procedures

· Managing roll-out and instruction of affiliates QMS procedures (including MDR obligations

· Supporting internal & external audits

· Supporting CAPA resolution

The ideal applicant;

· 3 or more years experience in a medical device RA/QA job role

· Good knowledge of EU medical device regulations

· Trained in the requirements of ISO 13485 and EU / UK MDR

· EU Competent authority experience

· Auditing experience – ideally but not essential – training will be provided

· Strong communication and presentation skills

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Deadline: 21-06-2024

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