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Job Details

Regulatory Affairs Manager

Company: Regulatory Professionals
Location: Hertfordshire
Reference: J32114
Closing Date: 23 Mar 18
Type: Full Time
Salary (£): Negotiable
Benefits: Circa £50,000 per annum

Job Summary:

Regulatory Professionals are working with medical device company who are looking to expand their portfolio within the healthcare industry. This client is seeking a Regulatory Affairs Manager to create and manage technical files for class I, IIa, and IIb medical devices.

Requirements:

Regulatory Affairs Manager
Medical Devices
Permanent
Circa £50,000 per annum
Hertfordshire, UK
Job Ref: J32114

Regulatory Professionals are working with medical device company who are looking to expand their portfolio within the healthcare industry. This client is seeking a Regulatory Affairs Manager to create and manage technical files for class I, IIa, and IIb medical devices.

Key Responsibilities:
* Create and manage technical files for Class I, IIa and IIb Medical Devices (including efficacy and stability data, risk management, clinical evaluation)
* Involvement in technical file data for Biocidal Product Regulation dossiers, Cosmetic regulatory and Detergent regulations
* Assisting with ISO 13485 and ISO 9001 Quality Management System
* Working on post marketing surveillance, packaging and artwork version control, design history of new products and document control

Application Requirements:
* Bachelor's degree in a scientific discipline
* In depth knowledge of medical devices, biocides, cosmetics and/or detergent EU regulations
* Previously or currently working at management level
* Experience liaising with FDA and associate regulations is desirable

Medical device, Class I, Class IIa, Class 11b, risk management, Quality Management, Biocides, Cosmetics, Detergents, EU, Regulatory, Manager, Project management, Watford, Hertfordshire, North London.

Apply for this job: Regulatory Affairs 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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