Graduate Regulatory Affairs Specialist Inbox
Market leading, Yorkshire based manufacturer of medical devices is experiencing growth, with requests to supply a more varied product range and services to a global customer base. These factors, combined with significant changes in the way medical device products are regulated means that the Regulatory, Certification, Clinical teams within the business will have to expand and become more rounded in their approach.
Working closely with the Quality Manager, who will be responsible for the personal development of this recruit, the Regulatory Affairs Officer 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.
· Has maybe completed a year in industry throughout their degree or held one post after University and now looking for a move into a company offering excellent training, support and career development opportunities.
· An understanding of Orthopaedic Implants; gained either through academic study or through industry experience.
· An interest in the regulatory requirements for placing products on the European Market.
· A methodical thinker, capable of making rational judgments 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 recruit will be viewed as a "developing role," with ongoing guidance and support being provided by the Quality Manager to bring the person up to speed on the regulations applicable to the medical devices industry, therefore becoming a true industry expert. On a day to day basis, the role will provide a high degree of job satisfaction through the varied problem solving challenges it presents.
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