Senior Product Manager - Medical Devices (1 year contract)
Jennine Kelly HR Consulting Calgary, Alberta, Canada
We are seeking a Senior Product Manager – Medical Devices to direct key initiatives for our industry-leading multispectral imaging device. This position represents a great opportunity to bring your unique capabilities and experience to strengthen our product management capabilities.
You Are :
- Passionate about technology and committed to improving the lives of patients
- Always looking deeper with an impeccable eye for detail
- A problem solver who thrives on challenges
- Motivated by exceptional results and the highest quality standards
Responsibilities :
Product Development & Lifecycle Management :
- Work closely with R&D, engineering, marketing, and sales teams to define product requirements and features.
- Ensure compliance with FDA, Health Canada, and EU MDR regulations and adherence to industry standards, with a strong focus on ISO 13485, IEC 60601, ISO 14971, and IEC 62304 (software lifecycle processes for medical devices).
- Lead cross-functional teams through design, prototyping, testing, V&V (validation and verification) phases, ensuring rigorous compliance with regulatory and quality requirements.
- Oversee product lifecycle from concept to launch, including post-market monitoring, risk management, and updates.
- Analyze market trends, customer feedback, and competitive intelligence to identify growth opportunities.
Cross-Functional Collaboration :
- Lead efforts in preparing regulatory submissions including 510(k), De Novo for the FDA, as well as documentation for Health Canada and EU MDR certification.
- Partner with quality assurance and regulatory teams to ensure compliance with industry standards, including software V&V per IEC 62304 and FDA software guidance.
- Collaborate with sales and marketing teams to understand customer pain points and requirements.
- Facilitate cross-functional communication to resolve challenges and meet deadlines.
Product Strategy and Roadmap :
- Participate in the development of the product roadmap for assigned medical devices, aligning with company goals and market opportunities.
- Monitor post-market performance and collaborate with engineering teams on software updates, risk management, and ongoing compliance.
Qualifications :
- 7+ years experience in product management with medical device experience.
- Prior experience overseeing software and hardware products is considered an asset.
- Strong understanding of ISO 13485, IEC 60601, and IEC 62304 is considered an asset.
- Excellent leadership, communication, and interpersonal skills.
Why work at Kent?
- Competitive salary and benefits package
- The opportunity to make a measurable impact in a dynamic and growing company
- Spacious office in Calgary's Beltline, close to transit and shopping
Seniority level : Mid-Senior level
Employment type : Contract
Job function : Product Management and Marketing
J-18808-Ljbffr
Create a job alert for this search