Senior Manager, Global Regulatory Affairs

POSITION DETAILS:

Job Location: Waterloo

Position Status: New Headcount

Compensation Range: $145,000.00-$165,000.00 per year.

AT NDI, THE WORK YOU DO HERE MAKES A DIFFERENCE.

Every day, your work supports the advancement of medical technology.

NDI is the recognized global leader and industry pioneer of Optical and Electromagnetic tracking technology. Backed by decades of innovation and expertise, we’re the strategic partner of choice for the world’s top medical device OEMs, advancing the development of OEM navigation platforms. Leading OEM navigation platforms rely on our technologies for accuracy and reliability across demanding applications, and as a strategic partner, we support them from concept through integration to commercialization.

Whether you're designing technology, supporting customers, or enabling the teams behind them, your work matters. Every role at NDI plays a part in shaping the future of medical technology innovation.

THE IMPACT YOU’LL MAKE:

At NDI, our measurement technologies support medical procedures and help improve patients’ lives. As Senior Manager, Global Regulatory Affairs, you will lead global regulatory strategy and execution for NDI’s product portfolio and broader product compliance. You will develop the team and work across Quality, R&D, Operations, Commercial, Clinical and Product Management to support international market access and business growth.

HOW YOU’LL CONTRIBUTE:

• Lead global market access and lifecycle compliance across NDI’s product portfolio, addressing all applicable international regulatory requirements.
• Lead and develop NDI’s Regulatory Affairs team members in Canada, US and Germany, set priorities, plan resources and manage approved budgets and external expertise.
• Oversee submissions, registrations, technical documentation, labeling and change assessments. Coordinate regulatory reviews and required approvals during development and before release, including radio equipment requirements such as RED where applicable.
• Lead regulatory intelligence and cross-functional implementation of new requirements, including applicable product, materials and packaging obligations such as PPWR, RoHS and REACH.
• Oversee regulatory reporting, post-market surveillance and regulatory coordination of recalls, field safety corrective actions and field safety notices, as applicable.
• Lead engagement with regulatory authorities and notified bodies; provide regulatory guidance and appropriate compliance evidence to OEM customers integrating NDI technologies.
• Advise senior leadership on regulatory risk, launch readiness and investment needs; improve regulatory processes across assigned products and sites.
• This role requires strong regulatory expertise in a complex and evolving global medical device environment.
• The ideal candidate demonstrates thorough knowledge of U.S. FDA medical device regulations—particularly 21 CFR Part 820 QMS, 21 CFR 803, 21 CFR 806, and complaint handling—as well as international standards, including ISO 13485 and ISO 14971.
• Familiarity with European Union Medical Device Regulation (EU MDR 2017/745), Canadian Medical Device Regulations (SOR/98-282), UK Medical Device Regulations, Switzerland’s medical device requirements, Japanese Ministerial Ordinance No. 169, and South Africa’s regulatory framework is expected.
• These capabilities ensures product and system compliance, sustained market access, and consistently high standards for quality and patient safety. Comprehensive understanding of regional regulations, registration pathways, and ongoing vigilance for regulatory changes is critical for success in this role.

EDUCATION AND PROFESSIONAL QUALIFICATIONS:

• A degree in science, engineering or a related discipline, or equivalent relevant education and experience.
• 10 or more years in medical-device regulatory affairs, with at least 5 years leading teams or major regulatory programs, with demonstrated success in managing and developing people. Strong FDA and EU MDR experience, knowledge of other international regulatory frameworks and experience with sterile medical devices. Ability to address requirements across medical devices, OEM components and broader product compliance.
• Proven leadership, strategic planning and stakeholder management skills, with sound regulatory judgment and a record of delivering cross-functional change.

ADDITIONAL STRENGTHS:

• RAC certification, OEM component experience, multi-site leadership and broader product compliance expertise are assets.
• Experience applying AI tools to regulatory work with appropriate human review, confidentiality controls and compliance with approved procedures.

THE BENEFITS OF JOINING OUR TEAM

• Competitive pay with a 4% RRSP match to help you plan for the future.
• A comprehensive benefits package that supports your health and well-being.
• Company-wide bonus program and regular salary reviews.
• Employee Stock Purchase Plan offering discounted company shares to help you invest in and benefit from our growth.
• A 37.5-hour work week with a hybrid work model available where responsibilities allow.
• Receive 15 vacation days starting on day one, plus a paid holiday shutdown in December to recharge before the New Year!
• A calendar full of employee social events and engagement activities to keep us connected.
• Professional and personal development support designed to foster your continuous growth and career advancement.
• Work where your contributions are valued — as a multi-year winner of Waterloo Region’s Top Employers and the 2025 Chamber of Commerce Business of the Year, we’re recognized for putting people first and fostering a culture of collaboration and excellence.
• Part of a growing global company with offices in Waterloo, Vermont, Germany, and Hong Kong.
• Conveniently located near GRT and ION transit stops, with free on-site parking available.

If you’re looking to join a collaborative and curious team guided by integrity, thoughtful problem-solving, and a commitment to doing things right, this could be the place for you. We support one another by building strong partnerships across teams and winning together through shared knowledge and diverse perspectives. You’ll be surrounded by people who are passionate about what they do, continuously learning, improving with purpose, and driven by work that truly makes a difference. If this sounds like the right fit for you, we invite you to apply online and introduce yourself.

We thank all candidates for their interest in joining NDI; however, only candidates invited for an interview will be contacted. We do not use artificial intelligence or automated decision-making tools in our recruitment process. All applications are reviewed by our hiring team. NDI is committed to providing an inclusive and accessible recruitment process. Accommodations are available upon request for candidates taking part in all aspects of the selection process. If you require accommodation, please let us know and we will work with you to meet your needs. Agency calls will not be accepted. For more information about NDI and this position, please visit our website: www.ndigital.com.