Regulatory Affairs Specialist

Description

Regulatory Affairs Specialist

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

Location: Bedford

The Vacancy

Our client is a world leader in the research, design and supply of advanced consumer diagnostic products. They have a joint venture, and their brand is recognised the world over as providing accurate home pregnancy and fertility monitoring tests.

They are looking for a Regulatory Affairs Specialist to join their Regulatory Affairs team on a full-time,12-month maternity cover contract.

The role will be based at their 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 our client’s 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.

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 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.

Our Client 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 our client 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 and you will be redirected to our client’s careers page to complete your application.

Ad ID: 5418046434