Regulatory Affairs Director
Our client is a well-established, dynamic and fast growing international medical devices business.
This is a particularly exciting time for this multi award winning, business as it continues to build on its success and growth. There are significant opportunities for our client to further develop its capabilities, products, export markets and continue to lead in the marketplace internationally.
This appointment will enjoy significant levels of autonomy and responsibility. The successful appointee will lead the regulatory teams and working with the executive team, be responsible for the commercial and operational success of the business, making a significant contribution to the performance of the business.
The successful candidate will enjoy a stimulating and rewarding high profile role within a genuinely exciting and respected business.
The Regulatory Affairs Director will be part of the Executive Team and report directly to the CEO. The role has overall responsibility for leading the regulatory affairs department in delivering an efficient and effective regulatory service to support the company’s goals.
This is the most senior regulatory affairs role in the company but is still expected to have some degree of ‘hands-on’ work.
The role will:
- Lead the regulatory aspects of the business and the regulatory affairs team to achievement of corporate goals
- Develop and implement plans to achieve department’s goals and strategies
- Together with the management team help to develop the company’s strategic plans and corporate goals
- Experienced Regulatory leader, Senior Manager or Director, who is equally comfortable contributing to Executive level discussions and understanding and getting hands on with technical detail.
- Experience of FDA/CE class 1, 2 and ideally 3 medical devices. Additionally, experience of non-EU/US regulatory systems would be highly beneficial.
- Regulatory experience gained in other of sectors could be considered such as pharmaceuticals, if there is also experience gained in medical devices within a candidate’s career.
- Able to lead, motivate, develop and delegate effectively to make best use of our experienced team
- Able to balance multiple projects as well as communicate well internally, managing expectations of other departments
- Strategic thinker, able to see the bigger picture, putting systems and processes in place accordingly