Current Vacancies

GROUP REGULATORY AFFAIRS & QUALITY SYSTEMS DIRECTOR

£80,000 + pa (equivalent) plus car, bonus and benefits.

West Midlands, UK or Nr Stockholm or Nr Amsterdam

Our client is without doubt a name synonymous with the best in the industry. They have an outstanding reputation in the design, manufacture and installation of a range of accessibility products for the elderly/infirm and are renowned for technical excellence and vision, together with an absolute commitment to the customer. Yet past achievements cannot be relied upon, the market is more challenging than ever and as such, the business is firmly engaged in growing market share and maximising its true potential.

To enable them to achieve these aims, we are looking to appoint an outstanding Group Regulatory Affairs & Quality Systems Director, who can shape and deliver transformational change within this progressive organisation.

Responsibilities;

• You will act as the Global Regulatory strategic lead for the organisation, where you will be accountable for group wide direction, policy setting and compliance for a broad range of Class I and Class II medical devices.

• In this new role, you will manage a small team and will bring clarity to the function, removing duplication in order to drive best practice throughput.

• You will lead the management of Global Regulatory Affairs and Quality Systems including the management of regulatory service providers within amongst others, UK/Europe, US and Canada.

• You will define and implement the Global Regulatory strategy whilst managing timelines and all appropriate submissions.

• Represent the organisation on the senior leadership teams on all Regulatory Affairs and Quality Systems activities to build improved compliance and bring global harmonisation of appropriate policies and processes.

• Lead the development, communication and life cycle management and review for all Regulatory Affairs & Quality Systems matters, through all existing and new product development whilst ensuring appropriate risk mitigation strategies are in place.

Person;

• Roles of this type are indeed rare and we are looking for an individual who can bring clarity, structure and direction to all Regulatory Affairs & Quality Systems activities.

• The type who knows how to create and build formidable partnerships, you will have extensive Regulatory Affairs & Quality Systems experience gained within a best in class forward thinking organisation.

• You will have extensive experience managing regulatory bodies on a global basis including FDA, MHRA, MDD, Health Canada, Swedish MPA etc.

• As such, you will have expertise in all appropriate national and international standards and regulations including but not limited to – FDA, CFR21, MDD, ISO13485, ISO9001, ISO14001, ISO45001.

• Your experience will have been gained within Class I and Class II Medical Devices where you will be working most likely for a key manufacturer within the medical or FMCG sector. Experience of bespoke/customised products would also be an advantage.

• Entrepreneurial, creative and intuitive in equal measure, you will be forward thinking, highly results orientated and the type who can bring clarity and direction to an organisation to achieve high impact and sustainable Regulatory Affairs & Quality Systems initiatives.

• You will relish the opportunity to advance your career within a progressive and dynamic market leading organisation.

Please reply with full CV and current salary details. Candidates who fail to respond in this manner cannot be considered. Quote reference number 15/282 to; consult@evanstaylor.co.uk

Interested? Please reply with full CV and current salary details quoting Ref No. "15/282" to: consult@evanstaylor.co.uk

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