Regulatory,Medical Devices, 6 month Scotland

Scotland  ‐ Onsite
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Keywords

Description

A Medical Device company based in Scotland are looking for a Senior Regulaotry Affairs Specialist on a 6 month contract.
This is a great opportunity for the successful candidate to support the RA Project Leads for a class III medical device.

Responsibilities will include:
* Supporting the project RA Lead during characterization, verification & validation, labelling & claims development.
* Supporting preparation of pre-market applications to regulatory agencies.
* Providing guidance to product development teams and other business partners as required regarding conformance with medical device regulations and standards and data required for product submissions; data required to substantiate product claims, and content of labeling, advertising, and promotional materials.
* Researching and consolidating global regulatory requirements to enable development of global regulatory strategies.
* Partnering with global regulatory affiliates and providing documentation to support international applications for new products/maintenance of existing product licenses.
* Assisting in the development of best practices for Regulatory Affairs processes

Essential criteria include:
* Degree qualified, preferably in a scientific or technical field with previous experience of working in a Regulatory or Compliance related role within a highly regulated environment
* Familiarity with medical device regulations in US and/or EU
* Demonstrated success in preparing medical device pre-marketing applications
* Strong organizational and project management skills
* Strong interpersonal, negotiation and problem solving skills; detail oriented
* Ability to work independently and collaboratively with minimal supervision

If you would like to apply for this role then please send your CV, with your location and availability to start.

Seasons greetings,

Kind regards,

Nathan Puxty
Start date
02/2015
Duration
6
From
Real Staffing
Published at
23.12.2014
Project ID:
827182
Contract type
Freelance
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