vor 9 Tagen

Regulatory Affairs and Compliance Manager

Institut Straumann AG

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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.

Regulatory Affairs and Compliance Manager

Participate on assigned product development teams by representing and
reinforcing Design Control, Quality Assurance and Regulatory Affairs
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
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
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)