Global Regulatory Affairs Director

at  SPD Development Company Ltd

Global Regulatory Affairs Director
Swiss Precision Diagnostics (SPD) is a world leader in the research, design and supply of advanced consumer in vitro diagnostic products. SPD is a joint venture between Procter & Gamble (P&G) and Abbott; and our brand Clearblue, is recognised the world over as providing accurate home pregnancy and fertility monitoring tests.
We are looking for a Global Regulatory Affairs Director to join our Site Leadership Team and lead our Regulatory Affairs team on a Full-Time, Permanent basis.
The role will be based at our Innovation Centre in Bedford, UK with option for Hybrid Working.
Reporting in to the site Managing Director, this role has accountability for end to end regulatory activities at SPD globally.
We’re looking for someone who has experience of leading and providing global regulatory services to business needs. This includes maintaining regulatory compliance for all currently marketed products, new market registrations and regulatory support for new initiatives. The role has specific responsibilities as the Person Responsible for Regulatory Compliance (PRRC) under EU IVD Regulation 2017/746.
The ideal candidate would have experience in areas of medical and in vitro diagnostic devices and would also have experience of FDA regulations in these areas and a strong knowledge of US and European regulatory landscapes.
As a people manager, the role holder provides technical supervision/assurance training coaching and mentoring to team members/direct reports and facilitates lifecycle activities.
The role holder will be expected to understand and adapt to their audience so good interpersonal skills and excellent written and oral communication skills are essential. Having the ability to communicate persuasively to gain commitment will be advantageous along with the ability to drive compliance as a competitive advantage.

We can offer you:

• Hybrid working
• 25 days paid annual leave plus bank holidays (pro-rata)
• Company pension scheme including competitive employer’s contribution
• Private Medical Insurance package with additional medical cash plan scheme
• Enhanced maternity and paternity pay
• Company supported employee Health & Wellbeing programme
• Life assurance
• Free electrical car charging points
• Beautiful parkland setting with excellent transportation links to Cambridge, Milton Keynes and London (road & rail)

If you require any reasonable adjustments to support you, at any stage during the application process, just let us know how we can help.
We are an equal opportunity employer and value diversity. We do not discriminate on the basis of race, religion, colour, national origin, gender.
SPD Swiss Precision Diagnostics GmbH (SPD) is a world leader in the research, design and marketing of advanced consumer diagnostic products.
Our SPD research centre is at the cutting edge of innovation, and is fully engaged in the development of reliable diagnostic products to empower women on their reproductive journey. We are committed to answering the needs of our existing and future consumers, through a continuous flow of new and innovative products

Please refer the Job description for details