Global Regulatory Affairs Director, Bedford
Client:
SPD Development Company Ltd
Location:
Bedford, United Kingdom
Job Category:
Other
EU work permit required:
Yes
Job Reference:
ff1bdb55c500
Job Description:
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 globally for 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 at our Innovation Centre in Bedford, UK with an option for Hybrid Working.
Reporting to the site Managing Director, this role has accountability for end-to-end regulatory activities at SPD globally. We seek someone with experience in leading and providing global regulatory services, including maintaining regulatory compliance for marketed products, new market registrations, and regulatory support for new initiatives. The role includes specific responsibilities as the Person Responsible for Regulatory Compliance (PRRC) under EU IVD Regulation 2017/746.
The ideal candidate will have experience with medical and in vitro diagnostic devices, familiarity with FDA regulations, and a strong understanding of US and European regulatory landscapes.
As a people manager, the role holder will provide technical supervision, assurance training, coaching, and mentoring to team members and facilitate lifecycle activities. Excellent interpersonal, written, and oral communication skills are essential, with the ability to communicate persuasively to gain commitment and 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
* 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 based on race, religion, colour, national origin, gender.
Please note that if you are NOT a passport holder of the country for the vacancy, you might need a work permit.
Bank or payment details should not be provided when applying for a job. All applications should be made via the 'Apply now' button.
#J-18808-Ljbffr