Venor is excited to partner with ClearDynamic in their search for a Medical Device Project Manager. ClearDynamic is a well-funded start-up with a bright future ahead. Their team is proudly developing a breakthrough material that offers safe, drug-free relief from joint pain, with the potential to offer a long-lasting treatment that can be efficiently administered in an approved clinic setting.

We are seeking a highly skilled and experienced Medical Device Project Manager to join the team at ClearDynamic. 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. ClearDynamic offers remote flexibility across central and eastern Canada, so if you are passionate about science and innovation with a keen interest in startups, we want to hear from you!

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.
• 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 ClearDynamic'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.
• 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.

Cross-Functional Collaboration:

• Foster effective communication and collaboration among cross-functional teams to ensure seamless project execution.
• Serve as a liaison between different departments, promoting a cohesive approach to achieving project goals.

Resource Management:

• Estimate, allocate, and manage project resources efficiently, including personnel, budget, and materials.
• Monitor and report on resource utilization, identifying opportunities for optimization.

Regulatory Compliance:

• Ensure that all medical device projects comply with relevant regulatory standards and guidelines.
• Collaborate with regulatory affairs teams 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.

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.

Venor is an Atlantic Canadian recruiting firm specializing in recruitment solutions, executive search, career transition & outplacement services.

#J-18808-Ljbffr