Regulatory Affairs & Compliance Manager SDIS (m/f)
17. Dec 2017
Place of work
Basel - Switzerland
Research + Development
Manager without direct reports
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.
- Participate on assigned product development teams by representing and reinforcing Design Control, Quality Assurance and Regulatory Affairs requirements.
- 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 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 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.
Please note: This is not a position for job starters - we count on your experience.
Florian Rupp, HR Partner, is your first contact for further questions you might have. Please apply via our online application system or send your application via E-Mail to firstname.lastname@example.org.
For this position, we are not asking for profiles of HR Consultancies and Recruiting Agents. Please respect this.
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