Job: Regulatory Affairs Associate

Job Title: Regulatory Affairs Associate
Contract Type: Permanent
Location: Cambridgeshire
Salary: £35000 - £40000 per annum, Benefits: Competitive Benefits
Start Date: 2017-04-26
Contact Name: Kirsty McKinnon
Job Published: about 1 year ago

Job Description

This exciting new role comes from a world leader in the design and manufacture of scientific and data analysis equipment. Currently supplying solutions to scientific and industrial markets globally they are looking to diversify their offering into the medical device sector.

They require an engineer experienced in product regulatory compliance to undertake regulatory activities and ensure compliance with relevant standards and directives across their full product range – both existing and NPD.

Further responsibilities will include:

-          Monitoring forthcoming regulation changes and planning accordingly to ensure the business maintains product compliance without interruption

-          Develop regulatory affairs project plans and schedules to support New Product introduction (NPI) projects

-          Assist the multi-disciplinary design and development team with defining product design requirements as well as validation testing

-          Create and maintain all necessary technical documentation

-          Act as primary contact for regulatory agencies

-          Contribute to the development of regulatory strategy and development of the regulatory affairs process and its inclusion within QMS

If this role is of interest please submit your CV demonstrating the following skills/experience:

-          A relevant degree preferably in an engineering or science discipline though relevant experience will be considered

-           Experience in new product development and regulatory compliance for global markets i.e. EU and US

-          Experience of ISO9001, ISO61010, LVDE, EMC, RoHS and CE Marking is essential. Experience with medical devices is also beneficial i.e. ISO13485, ISO14971, MDD, IVD, FDA 21 CFR part 820 and 510(k)