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Job Details

Senior Regulatory Affairs Specialist

Company: EPM Scientific
Location: Switzerland
Reference: 381663/001
Closing Date: 27 Dec 18
Type: Part Time
Salary (£): Negotiable
Benefits:

Job Summary:

Main Responsibility Medical Device Regulation implementation project * Prepare training material for RA and other departments. * Provide training for the different sites regarding MDR. * Support and participate in Industry Organization WG`s with relevance for RA. * Author and support guidance documents and procedures to ensure MDR compliance. ...

Requirements:

Main Responsibility



Medical Device Regulation implementation project

* Prepare training material for RA and other departments.
* Provide training for the different sites regarding MDR.
* Support and participate in Industry Organization WG`s with relevance for RA.
* Author and support guidance documents and procedures to ensure MDR compliance.



Post Market Engineering

* Review proposed product and process changes for impact on regulatory status of product
* Support of Post Market Surveillance activities



International registrations

* File submissions to international authorities (compile required documentation) for the products and directly interact with the competent authorities



Skill Requirements

* Working knowledge of and experience applying EU medical device regulations and guidance documents
* Ability to independently handle regulatory assignments of any complexity
* Ability to identify and assess business risks for a given regulatory strategy.
* Ability to lead regulatory aspects of projects as a core team member and ability to establish buy-in from other team members.
* Significant experience, typically 3-6 years, in a regulated industry, preferably in orthopedics

Apply for this job: Senior Regulatory Affairs Specialist

Contact Information:

Address:  Head Office
Ground Floor 21 Lombard Street London
EC3V 9AH
England
Tel:  +44 (0)20 3758 8855
Website:  Visit Our Web Site

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