Regulatory Affairs and Compliance Specialist

Technique Recruitment Solutions Limited
Bury St. Edmunds, UK
18 Feb 2019
15 Feb 2019
Contract Type
Level of qualification
A successful & well-established manufacturing company require a Regulatory Affairs and Compliance Specialist to join their team, to provide operational and documentation support within the medical device regulatory affairs department. The company is a manufacturer of medical devices ranging from Class 1 through to Class III, used within a wide range of interesting and challenging medical fields. The key responsibilities of the job role will include: Assist the R&D team in the formation of design assurance documentation and support the team with the current regulatory information required for new and innovative medical device designs Participate in all types of design and development team reviews including leading Risk Management and FMEA activities Create or review and approve the development and implementation of validation plans Preparing document packages for regulatory submissions and communicate with relevant regulatory authorities globally and within the EU Assisting with Clinical Evaluation, Post Market Surveillance and Vigilance activities with devices on the market Efficient administration and management of regulatory technical documentation Keep abreast of regulatory procedures and changes and providing general advice on regulatory strategy for new product developments, product improvements and process changes Contribute to the development and improvement of regulatory policies and procedures across the organisation and ensure compliance with the company Quality Management System Attend occasional off-site meetings, events and consultations with a broad range of project stakeholders including medical professionals The successful candidate will have the following qualifications and experience: Minimum of 2 years' experience in a Regulatory Affairs role for a Medical Device Manufacturer A degree or equivalent in a relevant life science, scientific or engineering-based discipline is preferable, but a combination of education and experience may be considered. As such, regulatory affairs experience working within a medical devices organisation, or R&D team, may be considered equal to a high level of education Knowledge of 93/42 EEC and Technical Files/Design Dossiers Ideally already have basic 2017/745 EU MDR knowledge and technical documentation experience working within an ISO 13485 2016 QMS system An in-depth knowledge of ISO 13485 Design and Development Assurance Principles In depth knowledge of ISO 14971 preferred Experience gained working in a Class I, IIa /IIb or Class III Medical device regulatory environment Knowledge of MEDDEV and MHRA guidance and experience with FDA regulatory framework would be preferable This role is an ideal opportunity for personal growth while working on several new, varied and interesting projects, which will provide a high level of job satisfaction, through various problem-solving challenges The position is working Mon -Fri with a salary of £37-£43k dependent upon experience, and company benefits package. Please apply online for consideration and further details. Technique Recruitment Solutions is a specialist engineering and manufacturing recruitment company based in Norfolk This job was originally posted as