Company: Clinical Professionals Ltd
Closing Date: 12 Nov 16
Type: Full Time
Salary (£): On Application
Regulatory affairs Manager Salary: £60,000. Chippenham. To manage all the regulatory aspects of Healthcare Products, work prioritisation and line management for the team, to include medical devices, food supplements, cosmetics and chemicals.
Regulatory affairs Manager
To manage all the regulatory aspects of Healthcare Products, work prioritisation and line management for the team, to include medical devices, food supplements, cosmetics and chemicals.
This role is located in a fast paced environment with multiple projects on the go at once and requires a dynamic, flexible and resourceful individual.
Key Responsibilities of position
Expert advice and guidance
Responsible and accountable for the maintenance and QC of product information.
Responsible for Departmental QMS activities.
Responsible for ongoing training and professional development of self and others.
Issue identification and resolution.
Responsible for time management and work prioritisation.
Advise business to meet its needs.
Essential Technical Skills required
Proven line management of a small team of regulatory professionals
Significant Regulatory Affairs experience of medical devices, food supplements, cosmetics and chemicals
In-depth technical knowledge of OTC medical devices (substances), food supplements and cosmetics in the UK and EU
Experience of drafting regulatory documentation including Technical Files and PIFs
Experience of reviewing promotional materials and labelling including health and nutritional claims and working with the PAGB and other industry bodies
Essential Behavioural/Management skills require
Ability to plan and prioritise workload
Confident and assertive, able to challenge the way things are done
Ability to work effectively in multidisciplinary and multicultural teams, and to work across a broad range of audiences
Adaptable and willing to work across different healthcare product areas for medical devices, food supplement, cosmetics and chemicals
Ability to understand business needs, think strategically and develop risk mitigation strategies
Ability to multicast and keep to deadlines
Work in a pressurised, fast moving environment
Clear communicator, both written and oral
Desirable skills/knowledge required
Experience of international (outside EU) registrations of devices, cosmetics and food supplements
Offer and acceptance details
Chippenham based role - free parking available over the road (dependant on capacity)
Small Gym on site shower facilities available
Full time 37.5 hrs (flexitime between hours of 8am - 6pm core hrs 10am - 4pm)
Clinical Professionals UK
33 Blagrave Street
|Tel:||0044 118 959 4990|
|Fax:||0044 118 956 0607|
|Website:||Visit Our Web Site|
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