Job Ref: 214335715

Date: 2021-08-02 12:32:17

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Job specification – Regulatory Specialist

6 month Contract

Medical Devices

The successful applicant should have the following profile:

* Be both literate and numerate to a high standard

* Life Sciences degree

* Minimum 3 years’ experience in a medical device regulatory position

* Team player with excellent organisational skills.

* A good communicator.

* A disciplined and detailed approach.

* Be highly proficient in IT skills, with the ability to learn new software packages both effectively and quickly

* Have excellent time management skills

JOB DESCRIPTION

* Reports directly to the Regulatory Supervisor and is responsible for assisting with Regulatory Affairs functions within the company.

* Administrate the Company’s Medical Device Files and ensure a periodic review of relevant documents to ensure ongoing compliance to all applicable regulatory requirements.

* Authorised Quality Representative to approve technical documentation

* Administrate regulatory aspects of NPI projects

* Undertake Foreign Market product registrations as required for Export Sales, working with Marketing Support as necessary

* Assist with complaint and CAPA investigations

* Prepare and be involved in all Regulatory audits both internally and by external organisations

* Work with the Marketing on any technical marketing literature as required

* Produce reports as required.

* To carry out any other duties, as requested by the Regulatory Supervisor, Quality and Regulatory Manager or any of the Directors, that are reasonable in relation to promoting the company image or products.

Can be based remotely, some office visits may be required on occasion and the induction is site based.

Up to £500 per day.

Start – Mid September 2021

Keywords:

RA, Regulatory Affairs, Contract, Medical Devices

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