MGR Regulatory Affairs

Switzerland, Zug, Rotkreuz RDI

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• Job facts

The Position

Roche Molecular Diagnostics (RMD) Regulatory Affairs manages regulatory submissions for RMD’s products worldwide (including U.S. and EU) for the purposes of market authorization for new products as well as on-market products. We also review product labelling, promotional materials, and publications for regulatory compliance. RMD’s products span from (mostly) PCR instruments and test reagents for Blood Screening to Virology and Microbiology and include products for professional laboratories as well as instruments and tests used in Point-of-care environments. A significant part of RMD’s submissions are for the US, however, another large part of the workload for the next few years include the implementation of the new EU IVDR and international submissions in markets including China. RMD Regulatory Affairs is located at both Pleasant, CA in the U.S, as well as Rotkreuz in Switzerland.

The position is primarily responsible for regulatory strategy development, regulatory submission preparation and post-market support of the Company's medical device / In vitro diagnostic products in global markets. Position may also have people management responsibility.

The advertised position offers:

• Manages regulatory responsibilities associated with the development, support, and manufacturing of the Company's medical device / In vitro diagnostic products (including compliance).


• Manages the development and implementation of regulatory strategies and plans to support the timely introduction of new products and the preparation and review of government submissions to achieve timely and cost-effective approval.


• Monitors and assesses global regulatory policy developments related to the Company's products.


• Reviews product labelling to ensure conformance with applicable regulatory requirements and/or approved product claims.


• May serve as a contact with affiliates to achieve international registration of devices and maintain such registrations.


• Frequent contact with external resources and contacts at various management levels concerning operations or scheduling of specific phases of projects.


• Position may have people management responsibility for direct and indirect reports which includes hiring/firing decisions, interviewing, selection, performance feedback, discipline, pay decisions and handling employee grievances/complaints.


• Oversees the "agent in charge" for audits and serves as primary liaison with plant compliance officers to direct strategy and documentation requests during an audit.


• Contributes to continuous improvement effort to optimize business processes and increase quality and efficiency standards

Who you are

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

To be successful in this role (you have to):

• Degree in engineering, natural sciences or IT


• Min 5 years regulatory affairs experience in the medical product industry, or similarly regulated environment


• Previous experience in a matrix work environment supporting multiple development and other projects


• Previous U.S. 510k/PMA or EU Notified Body assessment experience is preferred


• People management experience is a plus

Roche is an equal opportunity employer.

Regulatory Affairs, Regulatory Affairs > General Regulatory Affairs

• Who we areRoche Diagnostics International Ltd in Rotkreuz is one of the world's leading providers of diagnostic system solutions for clinics, laboratories and doctors' offices. The company employs over 2200 people in Rotkreuz and is one of Roche Diagnostics' main sites. Read more.
  
  Roche is an equal opportunity employer.


• Job facts
  
  
  
  • Location Switzerland, Zug, Rotkreuz RDI
  
  
  • Function Regulatory Affairs
  
  
  • Subfunction General Regulatory Affairs
  
  
  • Schedule Full time
  
  
  • Job level
  
  
  • Job type Regular
  
  
  • Division Diagnostics
  
  
  • Posted since 2018/09/03
  
  
  • Job-ID 201807-115589
  
  


• Get in touchMr. Malek Al-Odeh


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