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Senior Regulatory Affairs Manager (m/f/d)

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Schweiz | 
Temporary Employment
Project title: Senior Regulatory Affairs Manager (m/f/d)
Type of employment: Payroll
Industry: Medtec
Skills: Regulatory Affairs
Project start: Oct 2016
Project duration: 6-9 months
Location: Switzerland


Responsibilities:
  • Lead regulatory activities for a portfolio of Class IIb and III medical devices throughout the product lifecycle.
  • Prepare, review and maintain Technical Documentation in accordance with EU MDR (2017/745).
  • Coordinate regulatory submissions and product registrations in Europe and selected international markets.
  • Collaborate closely with R&D, Quality Assurance, Clinical Affairs and Manufacturing to support design changes and product modifications.
  • Assess regulatory impact of engineering changes and ensure continued compliance.
  • Support interactions with the Notified Body, including preparation for audits and responses to regulatory questions.
  • Review labeling, IFUs and product claims for regulatory compliance.
  • Monitor changes in global regulatory requirements and advise internal stakeholders on implementation.
  • Provide regulatory guidance during cross-functional project meetings and support risk assessments according to ISO 14971.

Reference number: 17708
Industry: Medizintechnik
Project start: 27.07.2026
Duration: n/a
Employment type: Temporary Employment
Contact
Julia Fruehwald
j.fruehwald@aristo-group.ch
+41 44 274 39 00
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