Regulatory Affairs Officer – Leading Medtech – Staffordshire - £Negotiable depending on experience, bonus, pension, healthcare, hybrid working, flexible hours

The Company

• Leading medtech company specialising in Software led IVDs / Medical Devices

• Established over 30 years

• Operate on a global basis

• Hybrid working with flexible hours within that

The Role

• Ensuring regulatory compliance for existing products

• Developing regulatory strategies for new products

• Montior markets for updates and changes to regulations

• Ensuring the QMS remains updated and adhering to legislation/standards

You

• 2-4 years of professional experience in IVD Regulatory Affairs

• Experience in regulatory submissions

• Knowledge of FDA and FDA requirements in relation to software

• Knowledge of IVDR Regulation 2017/746

• Knowledge of UK Medical Device Regulation

• Knowledge of ISO 13485, 14971, 27001 and standards IEC 62304 62375

What should you do next?

This Regulatory Affairs Officer role is one not to be missed; it encompasses the opportunity to work with a hugely innovative medtech company. To discuss this role further or to find out about other roles I’m currently working on, please get in touch or hit apply to submit your current CV.

Unless otherwise stated, if applying for a job within the UK or European Union, you must ensure that you are already authorised to work there.

Carrot Recruitment acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, colour, sex, age, national origin, religion, sexual orientation, gender identity and/or expression.

If there are any arrangements or adjustments we can make to assist you at interview then please let us know and we'll be more than happy to assist.