Life Sciences Project Manager

Vor 5 Tagen

Basel, Basel-Stadt, Schweiz TN Switzerland Vollzeit

Company Overview

TN Switzerland is a consulting firm dedicated to providing innovative solutions in the life sciences industry.

We strive to transform the sector through tailored approaches that prioritize quality and people. Our vision is to lead with talent and transform with purpose, creating lasting relationships with clients and empowering high-performing individuals.

Our team is guided by a results-oriented culture that fosters diversity, equity, and inclusion. We are agile and adaptable, responding to evolving business needs while utilizing technology and human-centric approaches to drive impactful results.


Job Description

The Medical Device Project Manager will play a key role in supporting medical device lifecycle management. This involves ensuring compliance, maintaining documentation, and managing change control processes for commercial products.

This role contributes to delivering excellence in regulatory compliance and operational efficiency across all stages of the product lifecycle.


Key Responsibilities

  • Review and ensure the quality of project deliverables aligning with medical device development lifecycle requirements.
  • Manage and update Design History Files (DHF) for commercial medical devices, ensuring compliance with applicable regulations and procedural standards.
  • Ensure accurate documentation and updates for product changes throughout their lifecycle.
  • Support product transfer processes and provide operational insights for seamless transitions.
  • Manage change control processes to ensure updates to product designs, documentation, or processes meet internal and regulatory standards.
  • Monitor compliance with medical device regulations, identifying and implementing areas of improvement.
  • Collaborate within a matrix organization, working with cross-functional teams to align on deliverables and timelines.
  • Facilitate clear communication with internal and external stakeholders to ensure effective project execution.
  • Utilize tools such as Agile, Subway, and 1QEM for project and quality management.

Required Skills and Qualifications

  • 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.
  • Experience with tools such as Agile, Subway, and 1QEM (preferred).
  • Ability to work independently and manage complex deliverables.
  • Exceptional organizational skills, with attention to detail in managing documentation and records.
  • Strong problem-solving abilities and adaptability in a dynamic work environment.
  • Excellent communication and interpersonal skills for cross-functional collaboration.
  • Self-motivated, proactive, and capable of working independently while meeting deadlines.

Benefits

  • Flat hierarchies and responsibility from the beginning.
  • People-oriented culture.
  • Diversity and inclusion-focused environment.
  • Global client projects in a multinational environment.
  • Flexible working hours and home office.
  • Individual professional development, training, and coaching.
  • Unlimited full employment contract.
  • Excellent remuneration package consisting of a competitive salary plus a substantial bonus.

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