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SH
SHQ Medtronic Int. Trading Sàrl
last mo.

Regulatory Affairs Specialist(m/w/x)

Lausanne
Full-timeOn-siteExperienced

Description

In this role, you will enhance regulatory processes and systems while collaborating with internal teams. Your day-to-day responsibilities will involve preparing submissions, guiding junior staff, and ensuring compliance with evolving regulations.

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Requirements

  • Bachelor's degree in Life Sciences, Engineering, Chemistry, or related technical field
  • 2-5 years of medical device regulatory experience tied to Swissmedic submissions and processes
  • Proficiency in German, English, and French
  • Experience in ISO 13485 Quality Management Systems and risk management (ISO 14971, EN 14971)
  • Experience with Swissmedic registration processes and technical documentation preparation

Education

Bachelor's degree

Work Experience

2 - 5 years

Tasks

  • Recommend improvements to systems and processes
  • Communicate regularly with internal stakeholders
  • Guide entry-level professionals and support staff
  • Coordinate and prepare document packages for regulatory submissions
  • Lead and compile materials for submissions, license renewals, and annual registrations
  • Recommend changes for labeling, manufacturing, marketing, and clinical protocols
  • Monitor and improve tracking and control systems
  • Stay updated on regulatory procedures and changes
  • Interact with regulatory agencies on defined matters
  • Suggest strategies for timely approvals of clinical trial applications

Languages

GermanBusiness Fluent

EnglishBusiness Fluent

FrenchBasic

Benefits

Competitive Pay

  • Competitive salary

Other Benefits

  • Flexible benefits package
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