Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist

Salary & Benefits: £45,000-£55,000

Location: Marlborough, Wiltshire

Industry: Medical Devices

A global supplier and manufacturer of adhesive-based products for the healthcare and industrial markets are looking for a Regulatory Affairs Specialist to join their Quality Team.

The Regulatory Affairs Specialist (Medical Devices) position is based at one of their smaller sites just south of Swindon within a friendly close-knit team.

Regulatory Affairs Specialist Requirements:

* Knowledge of quality systems in the medical device industry
* Strong knowledge guideline ISO13485
* An understanding of both MDR and MDD regulations would be ideal
* Ability to communicate effectively at all levels of the organisation

Regulatory Affairs Specialist Responsibilities:

The main responsibility of this role would be to help maintain and update the company's already created technical files. They range from being a critical supplier, a virtual manufacturer or a legal manufacturer for their clients and the breakdown of technical files represents this.

Other responsibilities of this regulatory affairs position include:

* Performing audits on the technical files
* Performing regulatory review of customer complaint (Post market surveillance)
* Provide regulatory support to the sales/R&D team

If you are interested in this Regulatory Affairs Specialist opportunity, click Apply Now and we will be in touch with you soon.