Regulatory Affairs Senior Specialist - International

SPD Development Company Ltd; Bedford; Hybrid; GBP 70,000 - 95,000; Full time

Benefits offered by this job

Hybrid working

Annual discretionary bonus

25 days annual leave + holidays

Pension scheme

Private Medical Insurance

Maternity and paternity pay

Health & Wellbeing programme

Life assurance

EV charging points

Parkland setting proximity

Job summary

SPD Swiss Precision Diagnostics GmbH in Bedford, UK, is seeking a Senior Regulatory Affairs Specialist - International to lead regulatory strategies for global markets. The role offers hybrid working and a permanent contract, with responsibilities spanning registrations, market access, and lifecycle management of medical device and IVD products.

The successful candidate will have a life sciences degree and extensive international regulatory experience, strong project and stakeholder management,

Qualifications

• Degree in life sciences or equivalent experience.
• Extensive experience in Medical Device and/or IVD.
• Proven track record of international product registrations.
• Strong project and stakeholder management skills.

Responsibilities

• Lead international regulatory strategies and registrations across multiple regions.
• Support product launches and market access with compliance expertise.
• Coordinate with regulatory consultants, distributors and external partners.
• Provide clear regulatory guidance to stakeholders and senior management.

Skills

Regulatory strategy

International registrations

Project management

Stakeholder management

Education

Life sciences degree

Tools

Regulatory management

Job description

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 & Gamble (P&G) and Abbott; 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 & 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, sexual orientation, age, marital status or disability status.

The Company

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.