Job Description

Regulatory Affairs Specialist - Innovation

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 the world over as providing accurate home pregnancy and fertility monitoring tests.

We are looking for a Regulatory Affairs Specialist \xe2\x80\x93 Innovation to join our Regulatory Affairs team on a Full-Time, Permanent Contract.

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

The Regulatory Affairs Specialist role supports SPDs product portfolio transition from IVDD to IVDR, and also the regulatory strategy and implementation for assigned new product development projects as directed by the Regulatory Affairs Manager \xe2\x80\x93 Innovation and the 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 examines new legislation and implements into processes if required, with initial focus on requirements as part of the IVDD to IVDR transition. The role will support new product concept work and business development (third party sourcing) projects. The role holder advises teams on the regulatory environment and requirements associated with the products being investigated but must also be focussed on identifying compliant solutions to regulatory problems that represent the least burdensome route.

We\xe2\x80\x99re 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 extensive hands on experience in IVD or Medical Device Industry and comprehensive knowledge of ISO 13485, European regulations for medical devices, FDA regulations for medical devices, Canadian Medical Device Regulations and other international standards and regulations for IVD and medical device products. Experience of working with Notified Bodies and regulatory agencies is also essential, and prior experience of working with or within start-up companies is desirable.

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\xe2\x80\x99s 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.

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.

SPD Development Company