Regulatory Affairs Senior Specialist - International
| Company: | Get Staffed Online Recruitment Limited |
|---|---|
| Salary: | £45,000 to £50,000 a year |
| Hours: | Full-time |
| Location: | Bedford, MK44 3UP |
| Working pattern: | Hybrid - 2 days remote |
| Job type: | Permanent |
| Posting date: | 22 Sept 2026 |
| Closing date: | 22 Oct 2026 |
Summary
Regulatory Affairs Senior Specialist - International
Location: Bedford
The Vacancy
Our client is a world leader in the research, design and supply of advanced consumer diagnostic products. They are a joint venture, and their brand is recognised worldwide for delivering accurate home pregnancy and fertility monitoring tests.
They are looking for a
Senior Regulatory Affairs Specialist to join their Regulatory Affairs International team on a
Full-Time, Permanent Contract.
The role will be based at their 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.
They'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.
They 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 them know how they can help.
Our client is an equal opportunity employer and value diversity. They do not discriminate on the basis of race, religion, colour, national origin, gender, sexual orientation, age, marital status or disability status.
The Company
Our client is a world leader in the research, design and marketing of advanced consumer diagnostic products.
Their 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. They are committed to answering the needs of their existing and future consumers, through a continuous flow of new and innovative products.
Interested?
Click “Apply” to complete your application.
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