Job: Compliance Engineer - R&D
|Job Title:||Compliance Engineer - R&D|
|Salary:||£35000 - £40000 per annum, Benefits: Competitive Benefits|
|Contact Name:||Kirsty McKinnon|
|Job Published:||over 1 year ago|
Stevenage – Commutable from Cambridge, Cambridgeshire and areas of Hertfordshire
This exciting new role comes from a world leader in the design and manufacture of scientific and data analysis equipment. Currently supplying electro-mechanical solutions to scientific and industrial markets globally they are looking for a compliance engineer to work on new product development projects to ensure they meet relevant regulatory requirements.
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.
This exciting role will see you join a growing business as they expand their product range into new markets. Joining them on this journey you will work to ensure products meet regulatory standards the business is already working to i.e. 610610 and will also help them achieve new certifications as they meet the regulatory requirements of their new markets.
Further responsibilities will include:
- Assist the multi-disciplinary design and development team with defining product design requirements as well as validation testing
- Develop regulatory affairs project plans and schedules to support New Product introduction (NPI) projects
- Monitoring forthcoming regulation changes and planning accordingly to ensure the business maintains product compliance without interruption
- 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 working with the development of electro-mechanical equipment
Experience with medical device regulations would be beneficial i.e. ISO13485, ISO14971, MDD, IVD, FDA 21 CFR part 820 and 510(k) but is not essential and the business welcomes applications from compliance engineers who are interested in working with them as they develop into this area.
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