Senior Medical Compliance Lead

Roche • Mississauga, ON

1d • CA$136,936 - CA$179,729 • Onsite

About The Position

At Roche, our commitment to quality in Pharma Development is unwavering. We deliver confidence in the integrity of our data, agility in our processes, and transparency with regulators, patients, and society. You will join our Global Quality team to lead and manage global medical compliance oversight, risks, and governance, ensuring we protect patients and align efforts across Roche Pharma and Diagnostics. In this pivotal role, you will shape and architect oversight, reducing duplication and ensuring consistency across the "One Roche" ecosystem. You will be at the heart of our Medical Device Council, driving data-driven insights to identify systemic risks and shepherding them through to resolution, ensuring a healthier future for everyone.

Requirements

• 7+ years of experience and a Bachelor’s or Master's degree in a scientific or quality-related field (or an equivalent combination of education, training, and experience)
• A deep understanding of Medical Device Regulation (MDR) in Europe or the USA and global GxP requirements.
• Proven critical thinking and problem-solving skills with the ability to perform strategic insight analysis.
• Exceptional social agility and the ability to connect and partner with senior executive leadership.
• High learning agility and the ability to navigate ambiguity while driving for continuous improvement.
• Fluency in written and spoken English; additional languages are a distinct advantage.

Responsibilities

• Lead the Medical Device Council coordination and manage the escalation of critical compliance topics.
• Identify and monitor cross-affiliate trends using data-driven insights to inform governance and mitigation strategies.
• Act as the primary point of contact for all functions and affiliates, ensuring a unified approach to medical compliance.
• Partner with cross-functional teams and "Critical to Quality" networks to enhance the medical compliance ecosystem.
• Guide others within the function and related communities, fostering an inclusive and high-performing work environment.
• Provide comprehensive compliance assessments and strategic insights to senior leadership.
• Focus on unlocking value creation while managing enterprise-level risks through to resolution.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior