Senior Regulatory Affairs Specialist - Bedford, United Kingdom - SPD Development Company Ltd

SPD Development Company Ltd

Verified Company

Bedford, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Senior Regulatory Affairs Specialist
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
Senior Regulatory Affairs Specialist to join our Regulatory Affairs team on a
Full-Time,
Permanent basis.

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

The Senior Regulatory Affairs Specialist's main focus is to provide knowledge and support on the development and maintenance of product labelling in European Economic Area (EEA), UK, Switzerland and US to ensure compliance with approved texts and regulatory requirements.

The role manages substantiation of product claims on a market specific basis, ensuring up to date documentation is available for all marketed products; and is responsible for compliance to Unique Device Identification legislation globally and supports post market surveillance activities.

The Senior Regulatory Affairs Specialist provides IVDD and IVDR technical knowledge for the wider Regulatory Affairs Team ensuring regulatory elements of distribution of SPD Swiss Precision Diagnostics GmbH (SPD) products in the EEA, UK, Switzerland and US markets are fulfilled.

We're looking for someone who has 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 desirable and a background in R&D would also be beneficial.

Applicants must understand the need for current Quality System/GMP/ISO compliance and have a meticulous approach with close attention to detail and strong organisational skills.

We can offer you:

Hybrid working
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)

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.