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Regulatory Affairs Consultant

vor 2 Wochen

Basel, Basel-Stadt, Schweiz KVALITO AG Vollzeit
About KVALITO AG

KVALITO AG is a forward-thinking consulting firm dedicated to transforming the life sciences and healthcare sectors. Our team of experts is passionate about delivering high-quality solutions that prioritize people and innovation.

Job Title: Medical Device Project Manager

This role involves supporting medical device lifecycle management by ensuring compliance, maintaining documentation, and managing change control processes for key commercial products.

Key Accountabilities:
  • Compliance and Regulatory: Ensure compliance with medical device regulations, identifying and implementing areas of improvement.
  • Documentation and Records: Maintain accurate documentation and records, ensuring seamless integration into workflows.
  • Collaboration and Communication: Collaborate within a matrix organization, working with cross-functional teams to align on deliverables and timelines.
  • Operational Efficiency: Provide operational insights for seamless product transfer processes.
Requirements:
  • Bachelor's degree or equivalent experience in Life Sciences, Quality Management, or a related field.
  • Proven experience in project management, particularly in a matrix organization.
  • Strong background in medical device development and lifecycle management, including regulatory compliance and DHF maintenance.
  • Familiarity with change control processes and operational workflows.
  • Fluency in English, both written and spoken.