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Regulatory Compliance Manager (f/m) 100% in Zug

Regulatory Compliance Manager (f/m) 100% in Zug

Job Title: Regulatory Compliance Manager (f/m) 100% in Zug
Contract Type: Permanent
Location: Zug, Switzerland
Industry:
Salary: Negotiable
Start Date: asap
Reference: SPPO2308_1503483400
Contact Name: Petra Ognjenovic
Contact Email: p.ognjenovic@sciproglobal.de
Job Published: August 23, 2017 11:16

Job Description

Regulatory Compliance Manager (f/m) 100%

For our client who is an internationally leading Medtech global enterprise in the field of diagnosis, monitoring, defibrillation and software solutions in the medical devices industry we are currently hiring a Regulatory Compliance Manager to strengthen the existing Team within Quality and Regulatory Affairs

Your responsibilities

  • Manage and maintain technical documentation acc. to European medical device directive and regulation
  • Close working with project team and serve as Regulatory Project Manager on guiding projects development including providing regulatory guidance and norm, reviewing technical plan and report, communicating to test lab, etc.
  • Primary responsible for regulatory compliance prior to device including software release and ensure regulatory control of the ERP-system
  • Create and revise policy, procedures and work instructions for device release
  • Coordinating global Regulatory Affairs functional activities to ensure effective support to achieve existing plans and objectives
  • Involved into change assessment process
  • Be part of review process for labelling and marketing documents
  • Support regulatory training on CE-marking process

Qualification:

  • Bachelor of Science or Engineer preferred in the Bio Medical Field
  • 3+ years of Experience within Regulatory Affairs
  • Experienced in international medical device
  • Experience with active medical devices
  • Very good knowledge of technical documentation and CE-conformity assessment
  • International registration experience including FDA 510(k)
  • Knowledge with PMA submission experience would be a strong plus
  • Fluent in English and German

SciPro is a people business. We specialise in sourcing, advising and introducing highly skilled life sciences candidates to our client partners across the globe, helping them to achieve their business goals. The art of recruitment isn't solely about filling jobs, it's about matching people with people and creating harmonious and successful working environments. As a leading staffing specialist with offices in the UK, Europe and North America our biggest USP is representing candidates of all levels across Research & Development, Operational Excellence & Performance, Manufacturing Quality, Compliance, Regulation, Data Management, Cost Optimisation and Innovation. We pride ourselves on being able to deliver to almost every requirement in your business, in any location you need it.

Are you motivated, committed and flexible? Do you enjoy taking the initiative and working independently? Do you have a highly developed quality awareness? Do you work conscientiously, and are you resilient to stress? Then please send your complete application documents by email to Petra Ognjenovic: p.ognjenovic@sciproglobal.de