Company: Regulatory Professionals
Closing Date: 05 Jan 17
Type: Full Time
Salary (£): On Application
Regulatory Affairs Manager Salary: up to £60,000 per annum - may be flexible for highly experience candidates Pension, healthcare, bonus, 25 days holiday Location: Wiltshire
Regulatory Affairs Manager
Salary: up to £60,000 per annum - may be flexible for highly experience candidates
Pension, healthcare, bonus, 25 days holiday
Are you looking for the opportunity to broaden your experience?
Would you like to work with a wide variety of products?
Are you looking to be part of a business which is expanding into new territories?
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.
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:
In-depth Regulatory affairs medical devices (substance rather than electrical) experience in the UK and EU (class I / IIa experience ideal)
Ideally OTC but not essential
Post market regulatory experience is essential
food supplements, cosmetics or chemical experience would be advantageous
Experience of drafting regulatory documentation including Technical Files
Line management experience desirable
510k experience desirable
Essential Behavioural/Management skills require
Ability to plan and prioritise workload
Confident and assertive
Ability to work effectively with a range of people and working styles
Adaptable and willing to work across different healthcare product areas
Ability to understand business needs, think strategically and develop risk mitigation strategies
Ability to multicast and keep to deadlines
Clear communicator, both written and oral
Key Words: Medical devices, regulatory affairs, UK, EU, Healthcare, OTC, Consumer Health, II, Ia, 13485, supplements, pharmaceutical, pharma
3rd floor 33 Blagrave Street Reading
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