Regulatory Affairs Specialist

Overview:

Multi award winning, Northern based manufacturer of Medical Devices has a need for a Regulatory Affairs Specialist. In this role, you’ll be instrumental in developing new products and guiding the transition of technical files from MDD to MDR standards.

The Roles:

The Regulatory Affairs Specialist will be responsible for ensuring that products comply with all the necessary National and International standards, guidelines and regulatory requirements in the markets where the products are sold. This involves the development of new and update of existing MDD essential requirements along with other Technical Files, aligning with evolving regulations.

The Person:

• Degree educated, or equivalent, in a life science or engineering discipline.
• You will bring valuable experience from a medical device regulatory environment.
• Capable of interpreting national and international medical device requirements along with National and International Product Standards.

The Opportunity:

This role will appeal to people who are keen to develop their careers in the regulatory field, to take on responsibility and through their hard work see tangible results.  The successful candidate will work within a small team of like-minded people who collaborate both well between themselves and with all other parts of the organisation.

As well as transitioning existing MDD technical files to MDR and UKCA standards, our client is also actively progressing strategic growth opportunities into new markets as well as the development of novel products to complement the existing portfolio. This will provide a superb opportunity for each person that joins to get involved in a broad range of regulatory initiatives.

Contact:

If you have the required background and experience and believe that you can make a true contribution to the organisation, then please send us your CV.

Airton Solutions is a recognised brand within the manufacturing and engineering sector. Based in Leeds we operate within the UK and internationally providing both clients and candidates with unrivalled levels of knowledge and customer service. Both Airton Solutions and its clients promote a policy of equal opportunities. Our policy is to treat job applicants and employees in the same way regardless of age, gender, marital status, sexual orientation, race, ethnic origin, religion, colour or disability.