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Job Details

Regulatory Specialist / Manager

Company: Regulatory Professionals
Location: London
Reference: J32065
Closing Date: 05 Mar 18
Type: Full Time
Salary (£): Negotiable
Benefits: Up to £65,000 per annum plus health, pension

Job Summary:

Regulatory Affairs Specialist / Manager Our client is an established and growing medical device company with a market leading product exported globally. Due to expansion, they are looking to hire a Regulatory Affairs Specialist / Manager.

Requirements:

Regulatory Affairs Specialist / Manager
Up to £65,000 per annum plus health, pension
North Hampshire or London
Job Ref: J32065

Our client is an established and growing medical device company with a market leading product exported globally. Due to expansion, they are looking to hire a Regulatory Affairs Specialist / Manager. This is a fantastic opportunity to join a company with great career progression prospects within Regulatory Affairs.
Reporting to the Director of Quality and Regulatory Affairs with one direct report, the successful RA Manager / Specialist will be identifying, monitoring and analysing new and existing medical device legislation, guidelines and standards for a wide range of performance, risk, quality and technical topics and best practices. You will also be communicating new regulatory requirements and risks to actively collaborate with the design and manufacturing teams. Further responsibilities include (but not limited to):
* Manage the maintenance of technical files
* Manage regulatory submissions to global territories including US and Far East
* Author and coordinate new submissions for global territories
* Liaise directly with regulatory bodies

Experience:
* 5 years' experience within a regulatory affairs position working on active devices
* Experience of electronic medical devices - IEC60601
* Experience of risk management within medical device IEC14971 would be advantageous
* Experience of FDA 510K product registration
* Good understanding of complaints and vigilance requirements for US / Europe - ideally
* Excellent communication, presentation and influencing skills

London, Hertfordshire, Essex, Middlesex, Bucks, Beds, Berkshire, Regulatory, Medical Device, 13485, 510(k), FDA, submissions, 60601

Apply for this job: Regulatory Specialist / Manager

Contact Information:

Address:  UK Office
3rd floor 33 Blagrave Street Reading
RG1 1LG
England
Tel:  +44 (0)118 9522 797
Website:  Visit Our Web Site

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