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Senior Diagnostic Device Manager

Takeda Pharmaceutical
Lexington, MA Full Time
POSTED ON 2/3/2025
AVAILABLE BEFORE 2/18/2025

Job Overview

We are seeking a highly motivated and detail-oriented individual to lead technical project management within our dynamic team.

This role focuses on project management of remediation tasks, lifecycle management of diagnostic services, and support for new product development and assessments within the diagnostic devices sector.

The ideal candidate will have a passion for medical technology, experience in diagnostic device and/or assay development, and a desire to ensure compliance with evolving regulatory requirements.

Key Responsibilities:

  • Oversee lifecycle management activities for ongoing and expanding diagnostic services.
  • Lead project management of remediation tasks to ensure compliance with changing regulatory landscapes.
  • Collaborate with cross-functional teams to gather data, analyze results, and implement improvements.
  • Maintain up-to-date documentation and records related to diagnostic devices.
  • Conduct research and stay informed about industry trends, standards, and regulatory requirements.
  • Identify opportunities for process improvement in diagnostic service/device development and work with leadership and cross-functional teams to implement effective solutions.
  • Provide technical support and troubleshooting assistance for diagnostic devices.

Qualifications:

  • Bachelor's degree in Biomedical Engineering, Biochemistry, Molecular Biology, or a related field.
  • 3-5 years of experience in the biotech or pharmaceutical industry.
  • Proven project management and organizational skills.
  • Ability to work effectively both independently and as part of a team.
  • Strong analytical and problem-solving abilities.
  • Excellent written and verbal communication skills.
  • Detail-oriented with a commitment to maintaining high-quality standards.

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