AX 4967 Associate Director Regulatory Affairs – Medical Devices

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Category: Regulatory Affairs Location: Marlow/ Buckinghamshire, United Kingdom Job Reference: AX 4967 Job Type: Permanent Package details: High Salary, Bonus, Pension, Life Assurance, Private Medical, Parking

JOB SUMMARY:

The Associate Director Regulatory Affairs, at Allergan, is responsible for strategic regulatory input into Global Development Plans and subsequent implementation, to ensure the registration of commercially successful products (Class IIb and Class 3 Medical Devices) in the EU and Emerging Markets Region. This role carries line management responsibility

BACKGROUND:

Allergan, with headquarters in California, is a multi-speciality health care company that discovers, develops and commercialises innovative pharmaceuticals, biologics and medical devices. The Company employs more than 8,000 people worldwide and operates state-of-the-art R&D facilities and world-class manufacturing plants. In addition to its discovery-to-development research organization, Allergan has global marketing and sales capabilities with a presence in more than 100 countries.

Allergan specialises in Ophthalmology, Neurosciences, Obesity Intervention, Medical Aesthetics, Medical Dermatology and Urologics.

This is a permanent position based within Allergan’s European hub based in Marlow, offering a professional, modern and friendly working environment where a culture of strong cross departmental liaison and career development is actively encouraged.

PRIMARY DUTIES:

You will utilize your excellent communication and influencing skills to ensure that the strategic and operational needs of the European region are included in the Global Development Plans for your Medical Device portfolio. You’ll then ensure your team will execute the strategy through the provision of clear and constructive regulatory input to assist in planning and issue resolution throughout the development and registration process within the optimal timeframe.

You will work closely with the regional commercial team to ensure that priorities are agreed for both lifecycle and development projects. In addition you will evaluate the regulatory implications of Regional Medical Studies for both corporately sponsored and investigator–led studies.

Whilst the main thrust of this role is regulatory you will also act as the management representative for Allergan Medical in line with ISO 13485:2003. You will have oversight of the QMS developing and maintaining a culture of continuous improvement whilst maintaining a state of inspection readiness.

You will also work closely with your pharmaceutical regulatory colleagues providing advice and guidance on drug/device combinations.

QUALIFICATIONS / EXPERIENCE REQUIRED:

Education and Experience:

Science or engineering graduate, ideally with post-graduate qualification in a relevant area and/or business qualifications coupled with sound knowledge of relevant Quality Standards, and European medical device regulations and guidelines.

Extensive Medical Device experience, including a successful track record in the registration and maintenance of products within Europe. Experience interacting with Competent Authorities and Notified Bodies, ideally including the hosting of Notified Body audits and working in cross-functional project teams.

Essential Skills and Abilities:

Proven managerial skills, with the ability to lead, motivate and develop staff with excellent organisational/ planning and negotiation skills. Excellent communication skills, both written and verbal (in English) with good interpersonal skills and the ability to influence others without formal authority. Ability to work effectively and collaboratively across the global organisation and cross-functionally.

KEYWORDS:

Medical Devices / Medical Devices Regulatory Director / Reg Affairs Associate Director / Medical Devices Regulatory Associate Director / Medical Technology Director / EU Reg Affairs / jobs / careers / vacancies / regulatory medical device jobs / Marlow / Allergan / jobs

TO APPLY:

If you wish to apply for this role please click below, or send your CV with a covering note to jobs@axess.co.uk  quoting reference 4967.

Alternatively to have a confidential discussion about this role please call Paul Foster on 0208 560 2300

ABOUT AXESS:

AXESS has been operating since 1990

We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development

We match professional candidates to the best permanent, contract and interim roles in the market

Visit us at www.axess.co.uk