Job: Regulatory Affairs Specialist (electro-mechanical products)
|Job Title:||Regulatory Affairs Specialist (electro-mechanical products)|
|Salary:||£35000 - £40000 per annum|
|REF:||KM - RAA SG|
|Contact Name:||Kirsty McKinnon|
|Job Published:||about 1 year ago|
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)
To Kirsty McKinnon firstname.lastname@example.org
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