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Quality and Regulatory Affairs Manager in Bern

Quality and Regulatory Affairs Manager in Bern

Job Title: Quality and Regulatory Affairs Manager in Bern
Contract Type: Permanent
Location: Bern
Industry:
Salary: Swiss Franc105000 - Swiss Franc130000 per annum
Start Date: ASAP
Reference: SPPO0703_1488896516
Contact Name: Petra Ognjenovic
Contact Email: p.ognjenovic@sciproglobal.de
Job Published: March 07, 2017 14:21

Job Description

Quality and Regulatory Affairs Manager in Bern

Our client is offering the opportunity to work in a dynamic team and being part of a young and motivated environment. Start of the position could be immediately or upon agreement

Our client is responsible to find solutions with the aim to revolutionize medical navigation systems toward minimally invasive procedures for the benefit of patients and improvement of their care.

This person will have the opportunity to work on a range of different complex development projects as well as manage regulatory projects in a nutshell.

Your Tasks:

  • Maintain and prepare technical documentation files for different devices and regulatory markets (Europe, U.S., etc.)
  • Manage registrations for different markets
  • Manage necessary post-market activities
  • Represent quality management on various development projects
  • Support quality requirements and risk management processes
  • Support V&V testing, usability testing and testing relating to standards compliance
  • Liaise with Notified Bodies
  • Participate in quality projects
  • Maintain current quality processes

Your Profile:

  • Bachelor's degree in science, engineering, healthcare or related field
  • Experience with U.S and European market regulatory requirements
  • Experience with ISO 13485 and quality management systems in a medical device
  • Experience with other ISO/IEC standards is a plus (10993, 14971, 60601-1, 62304, etc.)
  • Experience with quality auditing is a plus − Understanding of clinical evaluations and clinical trials is a plus
  • 510(k) or PMA submissions experience is a plus
  • Ability to work independently and as a team player
  • Excellent communication and documentation skills
  • English language is a must

In case of any further question, please do not hesitate to contact
Petra Ognjenovic: 0049 89 2109 4906.

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