9 days ago

Regulatory Affairs & Compliance Manager SDIS (m/f)

Institut Straumann AG

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We are looking for you as our new Regulatory Affairs & Compliance Manager SDIS (m/f)

In this role you will be responsible for the overall registration strategies, coordination, implementation, execution control and completion of product registration, assuring compliance with regulatory requirements for our SDIS (Straumann Dental Implant System) Portfolio. The position is based in Basel, Switzerland and reports to the Head of Regulatory Affairs & Compliance SDIS.

Regulatory Affairs & Compliance Manager SDIS (m/f)

Participate on assigned product development teams by representing and
reinforcing Design Control, Quality Assurance and Regulatory Affairs
Define product classification and regulatory pathway in EEA, United States and
Canada for assigned products.
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 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 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. Become part of a creative, inspired and engaged team on a mission:
Bring your ideas to life - create your footprint in the dental industry
You can expect an informal, hand-on working environment with opportunities to

Institut Straumann AG