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Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Job Title: Senior Regulatory Affairs Specialist
Contract Type: Contract
Location: Dunfermline
Industry:
Salary: Competitive
Start Date: ASAP
Reference: 15990 JM
Contact Name: Julie McEwan
Contact Email: julie.mcewan@nextphaserecruitment.com
Job Published: October 31, 2018 12:30

Job Description

The Role
My client, a medical device manufacturer based in Dunfermline, requires a Senior Regulatory Affairs Specialist to join their Regulatory department on a contract basis. This role is due to continued growth and a high number of projects across the existing team. This role will be pivotal within the team and the successful candidate will be responsible for driving regulatory strategies for the existing product portfolio alongside new innovative projects within the product cycle pipeline. The role will include working closely with CRO’s, bringing new technologies to market so previous clinical trial experience (as pertaining to regulatory affairs) will be advantageous. As a specialist, you will provide support and guidance companywide on the development and registration of the company’s diagnostic devices alongside overseeing all technical regulatory documentation to ensure compliance in accordance with ISO 13485. 

The Company
A growing medical device company, operating on a global platform that specialises in the diagnosis, treatment and prevention of retinal diseases and disorders. With over 25 years’ experience within this sector to draw upon they are at the forefront of innovation.  Placing high importance on work/life balance the company believe that professional and personal goals are of equal importance and provide an environment where both can be realised. A competitive salary and extensive benefits package are offered complementing a friendly and supportive company environment and valued employee ethos.

Experience
My client requires someone with Regulatory experience gained within Class II medical devices and someone that has already managed successful approval submissions in their existing role. Ideally your experience will have been gained working within electrical, connected devices but candidates from a combination device background would also be of interest. Risk management and hazard analysis are key functions of the role so in-depth knowledge and strong commercial expertise in this area is essential.

Please get in touch for a confidential chat about the role and the opportunity that exists with my client.