Regulatory Affairs Specialist

Vor 3 Tagen

Lausanne, Waadt, Schweiz Intuitive Surgical Vollzeit

Job Description

We are seeking a skilled Regulatory Affairs Specialist to join our team at Intuitive Surgical. As part of a 9-month project and the launch of a product in the biotechnology market, we require a candidate available immediately (within 1 month maximum). There are possibilities to continue on a permanent contract.

Your Key Responsibilities:

  • Prepare and compile regulatory documentation for submission to authorities like FDA, European Notified Bodies, Health Canada, etc.
  • Review analytical data from development and performance evaluation studies.
  • Provide guidance to staff and project teams on data and information required for successful license applications.
  • Develop regulatory requirements for product labelling and liaise with internal and external parties.
  • Maintain knowledge of new or updated regulatory requirements and industry standards.
  • Ensure maintenance of product regulatory documents and technical files to support compliance.
  • Liaise with regulatory authorities and external contract bodies.
  • Participate in product development projects to provide regulatory guidance.
  • Document changes in accordance with quality system requirements and communicate them to regulatory authorities.
  • Provide support, guidance, and training to team members.
  • Perform other duties as requested and ensure compliance with GMP, GDP, and other regulatory requirements.

Your Profile:

  • Relevant degree and/or work experience in a regulatory affairs environment.
  • Previous regulatory experience, knowledge of CE and FDA regulations, and experience in preparing and submitting regulatory documents.
  • Ability to prepare regulatory reports, sound knowledge of IT packages, and experience with regulatory submissions.
  • Team player with clear communication skills.
  • Proactive and able to work independently or within a team.
  • Attention to detail and ability to analyze information.
  • Ability to work under pressure and manage workload effectively.
  • Leadership skills and ability to build relationships with stakeholders.

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