Project Manager, Product Development - Dispositifs Médicaux

Duties and Responsibiliies:

• Manage the product development of medical devices class III and IIb according to the Design Control procedure.
• Participate in defining design inputs and specifications with the Marketing and Clinical team.
• Oversee manufacturing processes and biocompatibility testing.
• Participate in the risk management analysis in conformity with the harmonized standard EN14971.
• Together with all internal/external stakeholders, list the applicable standards, document the Design History File and the Device Master Record and develop the technical file for EC marking.
• Project management:
  • Ensure communication with Top Management (Directors and CEO).
  • Manage timeline and planning, anticipate tasks, risks and critical points.
  • Organize meetings with internal skakeholders and provide the minutes.
  • Use project management tool.
• Closely interact with Regulatory Affairs, Quality Affairs and Clinical Affairs.
• Provide support to Marketing and Sales team.
• Participate in external meetings with surgeons and key opinion leader.
• Coordinate outside consulting services hired for activities or coverage issues.
• Follow and maintain the company QMS.
• Provide weekly working plan.
• Perform all other related duties as directed by management.

Requisite Training and Experience:

• Education: Master in Life Science or advanced degree (Engineer, PhD, Pharm D).
• 5 years' experience in a related field.
• Fluent in written and spoken English.
• Excellent communication skills.
• Inventive, flexible, task-oriented, multi-skilled, autonomous, committed person.
• Strong knowledge of the medical device industry.
• Experience of the manufacturing processes and steps of medical device development.
• Experience in sterilization by irradiation is a plus.
• Experience in one of the following is a plus: neurosurgery, hemostatic agent, wound healing medical device, anti-adhesion application.
• Knowledge of Canadian standard, regulation and other applicable regulations needed for the business.
• Must be willing to travel both domestically and internationally as needed (average <20%).