57 days ago on straumann.ch

Regulatory Affairs and Compliance Manager

Institut Straumann AG

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Regulatory Affairs and Compliance Manager

Regulatory Affairs and Compliance Manager

Arbeitsort:Basel, Schweiz

Über Straumann

Straumann partners with passionate people who fit in with the agile dynamics of our size-for-success company. People at Straumann 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 team we are currently looking for a Regulatory Affairs and Compliance Manager.

  • Participate on assigned product development teams by representing and reinforcing Design Control, Quality Assurance and Regulatory Affairs requirements
  • Author the Regulatory Strategy for assigned products in consultation with the International Regulatory Affairs team and in-country subsidiaries as needed
  • Define product classification and regulatory pathway in EEA and United States for assigned products
  • Maintain current knowledge of the standards applicable to assigned products and communicate applicable standards and requirements to assigned project teams
  • Provide guidance to assigned project teams on the interpretation of applicable standards and regulatory rules, laws and guidelines, particularly when they have changed
  • Author certain product development documentation complying with Straumann design control requirements in order to facilitate their use in achieving and maintaining access to the markets in which the company participates
  • Review and approve product development documentation complying with Straumann design control requirements in order to facilitate their use in achieving and maintaining access to the markets in which the company is participates
  • Review and approve Design History Files to assure compliance with Straumann design control requirements, ISO 13485 and other applicable standards and regulations
  • 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 certain non-product labelling (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
  • 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

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 Straumann? If so, please forward your application to:

(Please not that we do not accept applicatoins neither CV's from any recruitment agencies)


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Institut Straumann AG
Peter Merian-Weg 12
+41 61 965 11 11

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