Regulatory Affairs Specialist

4 days ago

Bedford, United Kingdom SPD Development Company Ltd Full time

SPD Swiss Precision Diagnostics GmbH (SPD) is a world leader in the research, design and supply of advanced consumer diagnostic products and we believe we were the first in the world to receive IVDR certificates, for Quality Management System and Class B self-test devices. SPD was formed in 2007 as a joint venture between Procter & Gamble (P&G) and Alere (now Abbott) and our brands, such as Clearblue, are recognised the world over as providing accurate home pregnancy and fertility monitoring tests.

We are currently searching for a Regulatory Affairs Specialist - Innovation to join our Regulatory Affairs team based at our Innovation Centre in Bedford, UK. This role will be a Fixed Term Contract for 18 months and will follow a hybrid working pattern.

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 - 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 are looking for someone who**:
Holds a minimum of BSc degree or equivalent experience in life sciences (e.g. biological sciences, biochemistry, pharmacology etc.)

Has extensive hands on experience in IVD or Medical Device Industry

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

The ability to represent the company to the highest professional standards

Experience of working with Notified Bodies and regulatory agencies

Ideally, experience of working with or within start-up companies

Good interpersonal skills and excellent written and oral communication skills are necessary, particularly the ability communicate complex technical information clearly

**We can offer you**:
Hybrid working

Generous 25 days paid annual leave plus bank holidays

Company pension scheme including employer’s contribution

Excellent Private Medical Insurance package with additional medical cash plan scheme

Enhanced maternity and paternity pay

Company supported employee Health & Wellbeing programme

Life assurance

FREE parking including free electrical car charging points & disabled parking facilities

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

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.

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