Market leading, Northern based manufacturer of Class III Medical Devices has a new vacancy for an experienced Regulatory Affairs Specialist with an immediate start.
Day to day the Regulatory Affairs Specialist is 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 generation and development of new, and maintenance of existing, product submissions and the regulatory aspects arising there from. Duties will include:
- Preparing and submitting Design Dossiers to the relevant regulatory authorities within the EU and worldwide
- Take responsibility for nominated Product technical files and product specific design dossiers ensuring compliance with the relevant regulations.
- Participating in the Risk Management process working alongside the new Product Development Team
- Providing sound advice to management throughout the development of new product and product enhancement submissions, to ensure that the principles of the submission accurately reflect the regulatory requirements to aid timely product introductions and certificate renewal processes.
- Degree educated, or equivalent, in a life science or engineering discipline.
- Experience gained working in a Class III Medical device regulatory environment.
- An in-depth knowledge and appreciation of the regulatory requirements for placing medical devices on the European Market.
- A methodical thinker, capable of making rational judgements from available information and meeting targets in agreed timescales.
Current business opportunities, which include entry into new markets and the development of novel products, mean that the business has to add further depth and expertise to its Quality, Regulatory, Certification and Clinical teams. This will provide an ideal opportunity for someone within these areas to take the lead with positive performance resulting in longer term advancement opportunities. On a day to day basis, the role will provide a high degree of job satisfaction through the varied problem solving challenges it presents.
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 from 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.
Key words: Regulatory Affairs, Compliance, Clinical, Validation, Verification, DHF, Design Dossier, FDA, 13485, 14971, Medical Device, Class II, Class III, Orthopaedic.
|Job Category||Medical Devices|