Regulatory Affairs Manager - Medical Device

SRG Engineering ,
Manchester, Greater Manchester
More Details
Salary: £50000 - £65000 per annum

Overview

Regulatory Affairs Manager - Manchester This role will help support effective management of the organisation's regulatory affairs strategy, in order to support and fulfil the company's global commercial strategy. The role requires management and liaison with the senior management team, internal team functions, regulatory authorities, and external partner organisations. Key areas of responsibility: Managing a small RA team covering all areas of regulatory support for the business Lead the creation, management and maintenance of Technical Files / Medical Device Files for the company's product range in accordance with the requirements of the IVDD 98/79/EC and MDD Directive 93/42/EC, including CE-marking activities. Manage and lead the IVDR planning transition for the business. Qualifications, Skills and Abilities A degree in Life Sciences, either in genetics or molecular biology. Significant experience of working within the MDD and/or IVDD regulatory affairs arena. Evidenced experience of successfully managing/leading an RA team. Knowledge of ISO 13485 and IVD Directive requirements. Knowledge/application/training of the IVD Regulations. Knowledge/application of EU harmonised standards associated with ivds Excellent organisational skills and an ability to work to tight timelines. Demonstrates excellent/strong team skills. Very proficient in the use of IT tools and systems, including Microsoft Office suite, EDMS software. Excellent communication skills when liaising within the company and with external companies and authorities. For more information, please call Laith Mustafa on 01618682231 or email This job was originally posted as www.totaljobs.com/job/89959002

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