Job Description

Regulatory Affairs Specialist

Salary: £30,000 – £35,000 DOE plus benefits

Location: Bedford

Full-Time; 12-month Fixed Term Contract

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 Gamble (P&G) and Abbott, and our brand Clearblue, is recognised the world over as providing accurate home pregnancy and fertility monitoring tests.

We are looking for a Regulatory Affairs Specialist to join our Regulatory Affairs team on a full-time, 12-month fixed term contract.

The role will be based at our Innovation Centre in Bedford, UK with option for hybrid working.

The Regulatory Affairs Specialist role provides technical support for the Regulatory Affairs Department, ensuring regulatory elements of international distribution of SPD Swiss Precision Diagnostics GmbH (SPD) products, and implementation of changes to products in production are fulfilled.

This role supports validation of product claims on a market specific basis and makes sure up to date documentation is available for all marketed products. The role holder will perform regulatory reviews of complaints for reportability, and report as necessary.

We’re 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 comprehensive working knowledge of CE marking requirements for in vitro diagnostic medical devices or medical devices, and knowledge of international regulations for medical devices. Experience of working with Notified Bodies and Regulatory Agencies is also desirable, and an R&D background would be beneficial.

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.

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 and Wellbeing programme.

Life assurance.

Free electrical car charging points.

Beautiful parkland setting with excellent transportation links to Cambridge, Milton Keynes and London (road and 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

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.

Interested

Click apply and you will be redirected to our careers page to complete your application