Senior Regulatory Affairs Specialist

29 Nov 2018
27 Dec 2018
Regulatory Affairs
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

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