Regulatory Affairs Associate

Benefits Package:

£29,000 - £33,000
Genuine progression opportunities available
Extremely stable company
Further benefits

A world class medical device supplier with a very lucrative product range are rapidly expanding the organisation and as a result of this they're looking for a Regulatory Affairs Associate to join their team. Significant investment has enabled the company to acquire new businesses and grow the company brand worldwide, The company's product range is established throughout the UK Asia, America, Mexico, Europe and more with plans to branch out further next year, this makes it a great time to join this lucrative organisation and be a part of growing Regulatory team.

Role & Responsibilities:

• Supporting Regulatory colleagues to achieve continued compliance to relevant international regulations and standards for existing products, and to achieve compliance for new products.
• Collating and organising documentation to support registrations, audits, internal requests, and the development of Technical Files Storing of technical documentation within electronic document management systems.
• Assist in maintenance of Technical Files, including creation and control of documentation.
• Storage, organisation, control and revision of technical documentation within electronic document management system(s).
• Support transition from Medical Device Directive (93/42/EEC) to Medical Device Regulation (2017/745) where required.
• Liaise with all departments to support Regulatory department activities.
• Implement actions as directed by Regulatory Managers, including in support of Engineering Changes.
• Support Quality, Regulatory and Technical during external and internal audits.
• Accurately input data into regulatory logs / databases
• Support in global registration activities.

Knowledge, Skills & Experience:

• Degree is Science or Engineering
• Experience of ISO 13485
• Understanding of 21 CFR p820, MDD and/or MDR
• Experience of document management and/or ERP systems
• Experience with Medical Devices or a related area
• Basic understanding of the Regulatory profession.
  

If you are interested in this role or looking for something similar please contact David Biggs at or call for a confidential discussion on

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