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Regulatory Affairs & Compliance Manager Basel Switzerland,  

Straumann (company)


Posted on : 20 March 2017

Project Description


About us 
  • People at our company appreciate the opportunity to shape our future and create impact. 
  • Encouraging leadership and inspiring ideas from our people has guided us through our proud history of pioneering innovations. 
  • For our Headquarters  we are currently looking for a passionate Regulatory Affairs & Compliance Manager to join the Regulatory Affairs & Compliance Team SDIS & Bio materials.      



Your tasks  
  • Participate on assigned product development teams by representing and  reinforcing Design Control, Quality Assurance and Regulatory Affairs  requirements. 
  • Author the Regulatory Strategy in consultation with the International  Regulatory Affairs team and in-country subsidiaries as needed and provide  guidance to assigned project teams. 
  • Review and approve Design History Files to assure compliance with  company design control requirements, ISO 13485 and other applicable standards  and regulations.
  • Define product classification and  regulatory pathway in EEA and United States.  
  • Communicate changes in regulatory strategy and project status that can  impact planned product launch dates to International Regulatory Affairs and  Subsidiary RA staff
  • Review and approve non-product  labeling (e.g., marketing materials) to assure application of Quality and  Regulatory requirements, consulting with authors and designers as  appropriate. 
  • Create and maintain Technical Files / Design Dossiers for assigned  product or product groups in order to achieve and maintain CE Mark  certification 
  • Create regulatory submission documents for the United States [510(k),  PMA]. 
  • Assess, review and approve product and process change requests, in  consultation with International Regulatory Affairs, to assure that all  necessary regulatory activities are addressed prior to change  implementation. 
  • Manage interactions with notified bodies, competent authorities and  other regulatory bodies as appropriate to achieve and maintain market access  for assigned products.
  • Consult to the International  Regulatory Affairs team as necessary to achieve market access in markets other  than the EEA and US. 
  • Represent Quality and Regulatory as appropriate during internal audits  and third-party audit/inspection of design control activities. 
  • Investigate, review and approve tasks in the Exception  Management Process (i.e., CAPA s, NCMR s) as assigned.

     


Your profile 
  • Technical or scientific degree (equivalent experience considered). 
  • Minimum 3 years of experience in premarket RA or product development  QA. 
  • Knowledge of the standards and regulatory requirements for medical  products. 
  • Fluent written and spoken English; German language skills  valuable. 
  • Effective verbal and written communication. 
  • Perceptive with strong analytical skills. 
  • Ability to understand and to achieve the demands of rapid product  development cycles. 
  • Honest, positive, motivated, inquisitive, able to see the humor in  situations. 
  • Customer-driven, solution-focused, systems-oriented and emotionally  intelligent personality.

   


Working with Us:
  • It takes the commitment of bright and resourceful people to further  advance our innovative technology as well as our Swiss standard of precision  and quality. 
  • Adding your passion to our high-performance culture is a smart  move.
  •  Are you interested in a challenging job at our company.


Locations

Basel Switzerland

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