Regulatory Affairs & Compliance Manager - Switzerland
- 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.
- 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.
- 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.