Description
Hays ist ein weltweit führender Personaldienstleister, der sich auf die Rekrutierung von Spezialisten konzentriert - sowohl für den Projekteinsatz als auch für Festanstellungen und auf Zeit. In Deutschland, Österreich und der Schweiz vertrauen mehr als 600 internationale Topunternehmen auf unsere qualitätsgesicherten Prozesse, wenn Sie Experten suchen.We are looking for a
Regulatory Affairs Manger (m/f)
Referenz: -en
Beginn: 06/12
Dauer: 3 MM
Ort: im Großraum Hamburg
Branche: Herstellung von Bestrahlungs- und Elektrotherapiegeräten und elektromedizinischen Geräten
Ihre Aufgaben:
- Management of the relationship and Product Service Agreements with Canadian Standards Association (CSA)
- Represent Hamburg site as program manager operationally for CSA within the Category Program of Certification (CPC) accreditation
- Witnessed Manufacturer’s Testing (WMT) accreditation
- ISO17025 accreditation
- Prepare and oversee CSA contracts
- Managemenet of quarterly audits
- Management of listed factories
- Preparation and Managent of CSA submissions and projects
- Preparation and Managent on-site witness testing
- Preparation and Managent CB certification submissions and projects
Ihre Qualifikation
- Diploma, Masters Degree in Electrical Engineering, Medical Technology or equivalent education level
- Work experience with successful performance in a similar role
- Understanding of program management, project execution and interaction, and leading a cross functional team with all involved stakeholders and management teams
- Understanding of managing a (virtual) test lab according to ISO 17025, focusing on medical equipment test execution based on IEC 62354 and further requirements given by the CB Scheme of IECEE
- Understanding of safety requirements for electrical medical devices according to IEC 60601 series
- Ability to maintain and improve the organizational maturity within the CSA relationship
- Ability to explain regulatory requirements, procedures and strategies
- Ability to work in teams and motivate people, with very good communication skills
- Fluent in written/spoken German and English, especially for technical documentation
Skills:
- Regulatory affairs manager
Keywords: CSA Canadian Standards Association Category Program of Certification CPC WMT