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Regulatory Affairs Specialist
Regulatory Affairs Specialist
Location: Buckinghamshire
Salary: £40,000-£55,000 (dependent on experience)
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 an 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 and 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 are:
* 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
£40000 – £55000/annum