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Job Details

Head of Regulatory Affairs

Company: Regulatory Professionals
Location: London
Reference: J32488
Closing Date: 05 Mar 18
Type: Full Time
Salary (£): Negotiable
Benefits: £50,000 - £70,000 per annum + competitive benefits

Job Summary:

Head of Regulatory Affairs Regulatory Professionals are collaborating with an established and expanding Medical Device business in North West London who are looking for a Head of Regulatory Affairs.

Requirements:

Head of Regulatory Affairs
(6+ years' experience)
Location - North West London
Permanent position.
Salary - £50,000 - £70,000 per annum + competitive benefits package.
Reference number:J32488

Regulatory Professionals are collaborating with an established and expanding Medical Device business in North West London who are looking for a Head of Regulatory Affairs. The correct candidate should be a specialist in ISO 13485 and ISO 14971 regulations and have the drive/ability to lead the Regulatory department.

* Responsibilities include;
* Create, develop and maintain high quality regulatory compliant documentation
* Negotiate with relevant regulatory bodies on matters related to compliance of existing products and products undergoing development.
* Liaise with Project Development teams to ensure regional RA requirements are included in the project plan and prepare the pre-marketing documentation
* Lead and manage a team of 4 employees
* Assist with the expansion into Latin America, Asia-Pacific, Middle-East and North Africa markets.

Requirements;
* Relevant Life Science degree
* Hands on experience working on Regulatory Medical devices with 6+ year's industry experience.
* EU market experience is essential - LATAM, APAC or MENA experience is advantageous
* Experience creating documentation compliant with FDA CFR 820 and EC Medical Devices Directive 93/42/EEC
Experience working in compliance with key regulations such as ISO 13485 and ISO 14971
* Line Management experience is NOT required but you must have the attitude and drive to develop & led a team.

Remember if this role is not suitable for you please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 in vouchers of your choice.

Regulatory, Documentation, Medical, Devices, line-manage, London. North, West, South, Middlesex, Buckinghamshire, Hertfordshire, Berkshire

Apply for this job: Head of Regulatory Affairs

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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