Medical Device Lifecycle Expert

7 days ago

PointeClaire, Quebec, Canada Medicomp Inc Full time
Job Description

Job Summary

Medicomp Inc is seeking a highly skilled Product Lifecycle Manager to join our team. As a key member of our Product Lifecycle Management team, you will be responsible for developing and implementing strategies to ensure the health and sustainability of our medical device portfolio.

Key Responsibilities

  • Develop and implement product lifecycle strategies to maintain product health and enhance existing products to ensure revenue continuity.
  • Enable compliant, efficient, and risk-based execution of scaled phase-gate product development/design plans.
  • Create and maintain technical production specifications to meet regulatory requirements and customer needs.
  • Keep informed and assess impacts of changes in regulations and accompany marketing and commercial teams in their overall revenue objectives.
  • Collaborate with management in determining operating model, strategy deployment, and governance procedures.

Operational/Compliance Focus

  • Ensure that all documentation development is done as per regulatory standard within the product lifecycle according to design control and change control standard operating procedures.
  • Provide technical and scientific support to internal customers as well as technical support for global sourcing and manufacturing activities.
  • Negotiate with external consulting firms for development and testing.
  • Ensure continuous departmental regulatory readiness for audits and support inspections and audits of design control documentation.

Requirements

  • Bachelor's Degree in engineering, life sciences, quality/regulatory, or related technical discipline.
  • Minimum of 5 years of related work experience in product lifecycle/sustainment, product development, project management, and/or R&D of medical devices.
  • Demonstrated understanding of applicable US and Canadian regulations and compliance for medical devices.
  • Good oral and written communication skills and strong project management skills.
  • Bilingual in English and French.

Assets

  • Master's degree and/or professional certification in scientific, engineering-related technical discipline.
  • Six Sigma Green Belt certification, project/product management professional certification.
  • Understanding of applicable EU regulations and compliance for medical devices.

Equal Opportunity Employer

Medicomp Inc is an equal opportunity employer. We consider all applicants without regard to age, gender, gender identity or expression, sexual orientation, race, ethnic or national origin, religious beliefs, sex (including pregnancy and breastfeeding), disability or marital or family status. We welcome applications from all qualified individuals and encourage Indigenous persons, persons of color, LGBTQ+ and gender-nonconforming persons, persons with disabilities, women, and members of any other marginalized group.

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