Job Responsibilities:
Responsible for leading the Regulatory and Quality team to ensure achievement of product commercialization priorities and overall business objectives for new products and line-extension product offerings;

As well as to maintain/enhance health of marketed products and protect revenue continuity for these products for AMD Medicom North America.

Deliver the regulatory strategy and regulatory plans throughout the design and development.

Be the Company Representative and ensure strong relations with health authorities (US, Canada) and internal stakeholders with a strategic and proactive approach.

Utilize risk-based critical thinking to assure compliance with quality/regulatory requirements while simultaneously meeting business objectives.

Assess regulatory trends and drive continuous improvement to improve departmental efficiency for pre-marketing activities.

Create and maintain performance indicators for regulatory activities, providing trends and analysis.

Support process improvement and simplification to ensure continued compliance with regulatory requirements and Medicom Group policies/procedures.

Lead, mentor and develop team members to support achievement of business objectives.

Ensure/promote AMD Medicom values of accountability, teamwork, and customer centricity within team.


Position Requirements:
• Excellent knowledge of Canadian and US regulations, policies and guidelines for registration and compliance of medical devices (primary focus), natural health products and drug products.
• Strong strategic skills, risk-based critical thinking, and analytical skills in developing regulatory strategy, regulatory plans and achieving regulatory approvals considering business objectives and regulatory frameworks.
• Strong knowledge of design and development process for medical devices.
• Business acumen and flexibility and creativity with a solutions-oriented approach to meet business needs while simultaneously delivering compliant solutions.
• Strong leadership and management skills in developing high-performance and engaged teams.
• Excellent communication skills with the ability to interact and influence at all levels internally and with regulators and customers, both verbally and in writing.
• Demonstrated continuous improvement mindset, with a strong ability to improve and simplify processes, remove non-value activities, while respecting regulatory requirements.
• Results-driven and ability to handle multiple priorities at once within defined and/or tight timelines.
• Excellent organizational and technical writing skills.
• Strong personal leadership qualities.
• Minimum of 8 years experience in Regulatory Affairs environment, preferably in medical devices.
• Strong experience and demonstrated success in dealing with regulatory authorities (Canada, US) for regulatory approvals of new and innovative products.
• Minimum of 5 years of experience in personnel management and enabling a company culture.
• Experience in building strong relations with interna/external stakeholders.
• Experience in project management and coordination of multiple parallel tasks and projects.