Regulatory Affairs Specialist

taylorollinson Ltd; United Kingdom; On-site; GBP 40,000 - 55,000; Full time

Job summary

A life sciences business in Buckinghamshire is seeking an experienced Regulatory Affairs Specialist to ensure compliance with ISO standards and manage regulatory systems for in-vitro diagnostics. The role offers a salary of £40,000‑£55,000 and requires on-site work full-time. Candidates should have prior experience in a Regulatory position within the Medical Device or Diagnostics sector.

Qualifications

• Proven experience in the maintenance of Regulatory Systems.
• Knowledge of ISO 13485, ISO 9001, and ISO 17025.
• Experience with ISO-accredited audits.

Responsibilities

• Implementing regulatory directives to ensure compliance.
• Supporting the company's Quality Management Systems (QMS) in line with ISO standards.
• Ensuring regulatory compliance for in-vitro diagnostics.

Skills

Regulatory Systems Maintenance

ISO 13485

ISO 9001

ISO 17025

Environmental Management Systems

Job description

Our client is an established life sciences business based in Buckinghamshire. They distribute and manufacture high-quality and innovative products, including in‑vitro diagnostics, laboratory reagents, and biological materials, across the European life sciences market.

An opportunity has become available for an experienced Regulatory Affairs Specialist to join the company on a permanent basis.

This is a onsite position so the successful applicant will be expected to be on site full‑time.

The Role

This is a key role within the Quality and Regulatory team. The core responsibility is to act as the Regulatory Specialist for the company's ISO 9001, ISO 13485, ISO 14001 and Environmental Management Systems, and ensure the continuous improvement in the regulatory standards of the company.

• Implementing regulatory directives to ensure compliance
• Supporting the company's Quality Management Systems (QMS) in line with ISO 9001, ISO 13485, and ISO 17025
• Ensuring regulatory compliance for in‑vitro diagnostics – IVDD/IVDR and CE marking
• Scheduling audits in accordance with ISO 13485, ISO 9001, and ISO 17025
• Supporting with the management of non‑conformities and deviations

Suitable Applicants

Given the responsibilities of this role, we are seeking a candidate with prior industry experience in a Regulatory position, within the Medical Device or Diagnostics sector.

Key requirements

• Proven experience in the maintenance of Regulatory Systems
• Knowledge of ISO 13485, ISO 9001, and ISO 17025
• Experience with ISO‑accredited audits
• Prior experience with Environmental Management Systems

In return, our client offers the opportunity to join the company on a permanent basis in a pivotal role. The position offers a salary of circa £40,000‑£55,000 (dependent on experience), along with benefits.