Reference Number: JO-2010-456640
Senior Regulatory Affairs Manager
Rate: £58,000 – 60,000
Job Type: Permanent
Location: West Yorkshire

Senior Regulatory Affairs Manager
Location: East Yorkshire + Home working flexibility
Salary: Up to 60,000 per annum (Dependant on experience)
Job Type: Permanent
Job reference: JO-2010-456640

A highly reputable and expanding medical devices company based in the east of Yorkshire are seeking a Senior Regulatory Affairs Manager to join their global new products team. This client is looking for an experienced medical device expert who is an experienced line manager. Responsibilities include.

Managing a team of 3 regulatory professionals focused on new product registration activities
Maintain marketing authorizations to account for changes in the product or national legislation requirements and license renewals.
Prepare and approve data elements so they can be used in registration applications, variations and appeals
Managing the delivery of the Japanese and Chinese regulatory projects
Provide on-going regulatory advice to project teams throughout product and process development to ensure regulatory concerns are planned and accounted for

7+ years Regulatory Affairs experience working with Medical Devices, and a minimum of 2 years line management
Must be experienced working with either new product development or post-marketing activities for a large project
Experience working with EU and US markets, China/Japan would be advantageous
Minimum of a Bachelors Degree in a Scientific or Life Sciences Discipline

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