Professional Regulatory Affairs Manager

  • Contract type Permanent and Temporary - bis auf weiteres
  • Place
    Rotkreuz
  • Reference 107280-66699-1
  • Start date 04.02.2020
  • Sector Chemistry & Life Sciences
  • Publication date 14.01.2020

for our client in Rotkreuz we are hiring a:

Professional Regulatory Affairs Manager

Your assignment

- Manages the regulatory activities and supports the product care activities of the assigned (existing and authorized) product portfolio within SIS Workflow and IT Software/Hardware Projects, No Assays
- Assesses and communicates regulatory risks and challenges to project teams and interfaces with the lifecycle team (no direct contact with the regulatory authorities)
- Consultancy and active support of the R&D project teams during the development of new products and during the product lifecycle
- Accomplishes conformity evaluation for new and existing devices (also under the IVDR)
- Planning of Deliverables with other Regulatory Affairs professionals for product registrations, including compilation of corresponding
Software- and Hardware-Reports
- Provides insights into upcoming regulatory changes and trends prior to the issuance of new guidance, standards, laws, or regulations (MDR/IVDR)
- Ensures the interface between devision and other Regulatory Affairs teams for product approvals/clearances in the various regions
and fulfillment of requirements
- Works in a cross-functional, multi-site team to ensure alignment and harmonization

Your profile

- 5 years or more of experience as Regulatory Affairs Manager in electrical medical devices and/or IVD Instruments
- Experience with Development of Hardware and Software of IVD Instruments preferred
- Mechanical/Electrical Expertise
- English

Nice to Have:
- German
- Experience in a regulated environment or experience in GxP
- Bachelor or Master with technical or electricalbackground

Interested?

This multifaceted project provides the opportunity to apply and increase your expert knowledge in one of the largest pharmaceutical companies worldwide. To submit your complete CV including diplomas and references just use the button ‘Apply'. We are looking forward receiving your application today!

About Manpower
Manpower Switzerland offers its customers more than 55 years of experience in the recruitment, selection and placement of permanent and temporary staff, as well as in HR solutions. Its network of 50 branches active in all linguistic regions, 20,000 temporary staff, 1,500 permanent placements and over 5,000 clients – including small, medium and large companies – in all sectors of industry make Manpower one of Switzerland’s leading providers of workforce management solutions.
 
Our 3 promises
“We are passionate about what we do. This passion is a motivating and driving force, ensuring excellent placement opportunities for you.”
“We care about the people we work with. Including you. That’s why our collaborations are based on trust.”
“We take on our responsibilities. For you, that means security and exciting prospects.”
 
 

 

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