Job Ref: 214335241

Date: 2021-08-02 12:05:11

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Job specification – Regulatory Associate

Medical Devices

The successful applicant should have the following profile:

* Be both literate and numerate to a high standard

* Life Sciences degree

* Minimum 1 year experience in a 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

* 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

* Work with 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.

TRAINING PLAN

* The Managing Director gives a general introduction to the company

* A training schedule is devised to meet the needs of the individual. This will include the use of the computer system and relevant software packages.

* SOPs that have a direct application to the job should be reviewed and understood. This forms part of the training records

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