Medical Device Project Manager

Halifax, NS
IR Scientific

Venor is excited to partner with IR Scientific in their search for a Medical Device Project Manager. IR Scientific is an oral care company creating unique inorganic polymers. Their product Sensi-IP helps strengthen damaged teeth and provides immediate and long-term protection for three out of four Canadians who suffer from dentinal hypersensitivity. 

We are seeking a highly skilled and experienced Medical Device Project Manager to join the team at IR Scientific. The successful candidate will play a crucial role in overseeing the planning, execution, and delivery of medical device projects from conception to completion. This individual will be responsible for reviewing and reporting on the overall program, making technical decisions, and the early identification of risks and their mitigations. This role will collaborate with cross-functional teams, manage resources effectively, and ensure that projects are completed on time, within scope, and in compliance with regulatory standards. In addition, this position provides the opportunity to develop and apply advanced project management and product development principles, theories, and techniques and have a tangible impact on the business and on improving patient care.

What you’ll be doing:

Project Planning and Coordination:

  • Develop comprehensive project plans outlining scope, timelines, milestones, and resource requirements.
  • Coordinate with stakeholders, including R&D, Operations, Key Opinion Leaders (KOLs), Contractors, and Quality Assurance teams, to ensure alignment with plan and project objectives.

Team Leadership:

  • Identify project goals and direction; set a clear vision and move forward with passion.
  • Empower and motivate your project team by clearly setting expectations related to quality and performance and ensuring the team works effectively.
  • Establish good communication practices with team members including outside vendors.
  • Use creative ways to solve problems through the use of divergent/convergent thinking when dealing with bottlenecks and project variances.
  • Further expand IR Scientific’s capability in both project management and product development by introducing new techniques and refining existing techniques
  • Make scientifically supported recommendations for promising initiatives most likely to achieve company objectives. Stay informed of current state of the art in relevant scientific and technical areas.

Risk Management:

  • Identify potential risks and challenges associated with medical device projects and implement mitigation strategies.
  • Stay abreast of regulatory changes and industry trends to anticipate potential impacts on project timelines and deliverables.

Resource Management:

  • Estimate, allocate, and manage project resources efficiently, including personnel, budget, and materials.
  • Monitor and report on resource utilization, identifying opportunities for optimization.
  • Facilitate the establishment of cohesive project teams to support the ability to effectively work towards common goals.
  • Foster open and effective communication and collaboration among cross-functional team members and with suppliers to ensure seamless project execution.
  • Support quick resolution of conflicts between team members related to the project.

Regulatory Compliance:

  • Promote compliance with relevant regulatory standards and guidelines.
  • Collaborate with quality and regulatory affairs to navigate and address regulatory requirements throughout the project lifecycle.

Quality Assurance:

  • Understand, comply, and contribute to the Quality system, regulatory requirements, and business practices necessary to complete company goals.
  • Implement and uphold quality assurance processes to guarantee the delivery of high-quality medical devices.
  • Conduct regular reviews to ensure compliance with quality standards.

Project Reporting:

  • Generate regular project status reports for senior management and other project stakeholders highlighting key achievements, challenges, and upcoming milestones.
  • Communicate project updates to stakeholders and address any concerns or questions.
  • Maintain accurate and up-to-date project data and records.
  • Prepare project documentation and ensure compliance with required design control processes.

What we are looking for:

  • Bachelor’s degree in engineering, project management, or a related field.
  • Proven experience (3+ years) in project management, significant preference will be given to those within the medical device industry.
  • Prior history working in an FDA and/or ISO-regulated development environment; ideally 21 CFR 820 and ISO 13485
  • Knowledge of FDA 510(k), PMA, De Novo process, or Clinical Trials is strongly preferred.
  • Proven ability to collaborate cross-functionally and demonstrate leadership.
  • In-depth knowledge of regulatory requirements, quality standards, and project management methodologies.
  • Excellent interpersonal, communication, and leadership skills.
  • Strong analytical and problem-solving abilities.
  • PMP or other relevant project management certifications are a plus.

What’s in it for you?

  • Fast-paced environment that encourages self-development and growth.
  • Incentive Stock Options Plan (ISOP), health benefits and professional development opportunities.
  • IR Scientific offers a flexible work environment, a remote work arrangement will be considered for strong candidates living outside of Halifax

At Venor, we embrace a culture of belonging in the workplace. No matter who you are, where you’re from, how you think, what you believe in, or who you love, we welcome your application. We all come from different backgrounds and different walks of life, bringing in unique perspectives and experiences. We encourage applications from 2SLGBTQ+, Black, Indigenous, and People of Colour (BIPOC), women, newcomers to Canada, and people with disabilities.

To learn more about this exciting opportunity, contact Nick Misener via nick@venor.ca or Steph MacIntosh via steph@venor.ca.

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For: Medical Device Project Manager
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