Manufacturing Operations

Regulatory Affairs Specialist

Full Time

Overview:

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 increased pressure from the FDA and other regulatory bodies means that the Regulatory, Certification, Clinical teams within the business will have to expand and become more rounded in their approach.

The Role:

Reporting to the Quality Manager, 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.·

The Person:

· Degree educated, or equivalent, in a life science or engineering discipline.

· Experience gained working in a Class IIa/ IIb or 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.

The Opportunity:

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.

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