Regulatory Affairs Senior Specialist - International

Regulatory Affairs Senior Specialist - International Location: Bedford The Vacancy Swiss Precision Diagnostics (SPD) is a world leader in the research, design and supply of advanced consumer diagnostic products. SPD is a joint venture between Procter and our brand Clearblue , is recognised worldwide for delivering accurate home pregnancy and fertility monitoring tests. We are looking for a Senior Regulatory Affairs Specialist to join our Regulatory Affairs International team on a Full-Time, Permanent Contract . The role will be based at our Innovation Centre in Bedford, UK with an option for Hybrid Working . The Senior Regulatory Affairs Specialist - International role leads the delivery of regulatory strategies for international markets, product registrations and business growth initiatives . Reporting to the Regulatory Affairs Manager - International, the role plays a key part in supporting product launches, market access and ongoing compliance across a diverse range of global territories. The role provides expert regulatory guidance and technical expertise for the registration, maintenance and lifecycle management of medical device and IVD products across regions including CIS, Asia, the Middle East, Africa and other emerging markets. This includes assessing regulatory requirements, supporting market expansion opportunities and advising on the impact of product, manufacturing and labelling changes. Working closely with internal stakeholders and external regulatory partners, distributors and consultants, the successful candidate will lead complex international registration activities and help deliver compliant, practical and commercially effective solutions that support growth in existing and new markets. We're looking for someone with a degree in a relevant life sciences discipline (or equivalent experience) and extensive experience within the Medical Device and/or IVD industry . Candidates should have a proven track record of successful international product registrations, strong knowledge of global regulatory frameworks and experience developing regulatory strategies that support international market access. Strong project management, analytical and stakeholder management skills are essential, along with the ability to communicate complex regulatory requirements clearly and provide strategic recommendations that support business objectives. Experience managing regulatory consultants, distributors and external partners would be highly advantageous. We can offer you: Hybrid working Annual discretionary bonus 25 days paid annual leave plus bank holidays 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