Regulatory Affairs Specialist - Innovation


Company:	Get Staffed Online Recruitment Limited
Salary:	£35,000 to £40,000 a year
Hours:	Full-time
Location:	Bedford, MK44 3UP
Working pattern:	Hybrid - 2 days remote
Job type:	Permanent
Posting date:	8 Sept 2026
Closing date:	8 Oct 2026

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Summary

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 between

Procter & Gamble (P&G) and

Abbott; and their brand is recognised worldwide for delivering accurate home pregnancy and fertility monitoring tests.

They are looking for a

Regulatory Affairs Specialist - Innovation to join their Regulatory Affairs 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 Regulatory Affairs Specialist role supports the development and execution of regulatory strategies for

new product development projects and business development opportunities as directed by the Regulatory Affairs Manager - Innovation and the Global Regulatory Director.

The role fundamentally

provides technical regulatory knowledge and guidance on global regulations, specific to

In Vitro Diagnostic Medical Devices (IVD) and Medical Devices (MD). As part of this, the role supports regulatory strategy implementation, market access activities, regulatory intelligence and surveillance activities, and the assessment of emerging regulatory requirements, standards and industry trends.

The role supports

innovation projects from concept through to commercialisation, including third party sourcing opportunities. Working alongside the Regulatory Affairs Manager - Innovation, the role provides

regulatory guidance to cross functional teams and supports the identification of compliant, practical and efficient solutions to regulatory challenges.

Our client is looking for someone who holds a minimum of

BSc degree or equivalent experience in life sciences (e.g. biological sciences, biochemistry, pharmacology etc.) and has hands-on experience in the

IVD or Medical Device Industry. The role holder should have good working knowledge of

ISO 13485, IVDR (EU 2017/746), MDR (EU 2017/745) and FDA regulations for medical devices, and other international standards and regulations for IVD and medical device products. Experience of working with

Notified Bodies and Regulatory Authorities, supporting product development activities and preparing regulatory submissions and technical documentation would be highly advantageous.

The role holder will be expected to represent the company to the highest professional standards so good interpersonal skills and excellent written and oral communication skills are essential along with the ability to communicate complex technical information clearly.

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.

They are 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.

Apply for this job