Life Science Consultant, Medical Device Project Manager

Vor 7 Tagen

Basel, Basel-Stadt, Schweiz KVALITO AG Vollzeit

Join our Team of Enthusiasts

At KVALITO Consulting, a women-owned business founded in 2013, we are dedicated to transforming the life sciences and healthcare sectors through tailored, innovative solutions that prioritize quality and people. Guided by our vision to lead with talent and transform with purpose, we are committed to creating lasting, high-value relationships with our clients and empowering high-performing individuals to reach their full potential.
At KVALITO, we embrace diversity, equity, and inclusion in every aspect of our work, fostering a results-oriented, ambitious, and caring culture. Our purpose-driven team is agile and adaptable, ready to learn and respond to evolving business needs. Together, we champion a culture that balances excellence with empathy, utilizing technology and human-centric approaches to drive impactful results.
If you're passionate about making a difference and eager to grow within a company that values inclusivity and high performance, KVALITO could be the place for you. Join us in creating transformative solutions that empower our clients and leave a legacy of excellence in consulting.
Learn more about us at: www.kvalito.ch

KVALITO Life Science Consultant, Medical Device Project Manager

Location: Hybrid (Remote/On-site in Basel, Switzerland)

Mission:
The core mission of the Medical Device Project Manager is to support medical device lifecycle management by ensuring compliance, maintaining documentation, and managing change control processes for key commercial products. This role contributes to delivering excellence in regulatory compliance and operational efficiency across all stages of the product lifecycle.
Key Accountabilities:

  • Review and ensure the quality of project deliverables in alignment 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.
  • Follow company-specific procedures and guidelines to ensure seamless integration into workflows.


Key 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.


Key Competencies:

  • 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.


We offer great 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
  • Involvement in global conferences
  • Individual professional development, training, and coaching
  • Unlimited full employment contract
  • Excellent remuneration package consisting of a competitive salary plus a substantial bonus


If you are a self-motivated and reliable professional who enjoys a hands-on role in business operations, please submit your CV and a cover letter

We look forward to hearing from you

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