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Job Details

Senior Regulatory Manager, Devices

Company: Key People Limited
Location: Berkshire
Reference: 1610-1
Closing Date: 16 Dec 16
Type: Permanent
Salary (£): 60,000 - 80,000
Benefits:

Job Summary:

An excellent opportunity has arisen for a Senior Regulatory Affairs Manager to join a leading Pharmaceutical company based in Berkshire. This role has become available through growth within the company and can offer excellent career progression and very diverse project and work! This is an urgent requirement and it is essential that you have a strong background in CE marking expertise and Class III med device experience.

Requirements:

An excellent opportunity has arisen for a Senior Regulatory Affairs Manager to join a leading Pharmaceutical company based in Berkshire. This role has become available through growth within the company and can offer excellent career progression and very diverse project and work!

This is an urgent requirement and it is essential that you have a strong background in CE marking expertise and Class III med device experience.

Main Responsibilities:

• You will be the CE Mark lead for EU registrations.
• You will be working with all classes of device but predominantly Class III
• You will work within a multi-matrix team and work across all products as the CE mark expert, but you will be the lead for 4 product portfolios. Some of these products will be owned by the company, and others will be transferring to the company – in this case you will provide input and guidance to legacy companies and new acquisitions.
• You will be second in command to the Associate Director and head of the department.
• Mentoring of junior colleagues and help in decision making, and stepping up when the Associate Director is away or called onto project work.
• Lead line extensions which you will work closely on with the Global Regulatory Lead in the US office.
• Longer term you will be responsible for implementing new legislation regarding recertification and reclassification.
• You will also lead on audits and inspections for the EU – this will mean travel to the US will be involved.

Experience Required:

• Above country (EU) experience is essential.
• Class III medical device experience is ideally required, but this can be overlooked as long as you have CE Marking experience – this is essential!
• Previous mentoring or line management experience
• A passion for device work and a strong ambition to work with a diverse team and drive projects forwards.

For further details about this role or other opportunities within Regulatory Affairs please contact Tim Barratt on +44 (0) 1727 817 626 or email a copy of your CV to tbarratt@keypeople.co.uk

Apply for this job: Senior Regulatory Manager, Devices

Contact Information:

Address:  Head Office
Catherine House
Adelaide Street
St Albans
Hertfordshire
AL3 5BA
England
Tel:  Tel: 44 (0) 1727 811634
Fax:  Fax: 44 (0) 1727 844838
Website:  Visit Our Web Site

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