Senior Medical Compliance Lead

At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

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.

The Opportunity:

In this pivotal role you will shape and architect oversight reducing duplication and ensuring consistency across the OneRoche 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.

• 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.

Who You Are:

You are a proactive leader with a deep understanding of global Health Authority expectations and a passion for navigating complex regulatory landscapes. You thrive in international multicultural matrix organizations and bring a OneRoche mindset to everything you do.

To be successful in this role you bring:

• You bring 7 years of experience and a Bachelors or Masters 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.

Relocation Benefits are not available for this job posting.

#MQRS

The expected salary range for this position based on the primary location of Mississauga is 136936.00 and 179728.50 of hiring range. Actual pay will be determined based on experience qualifications and other job-related factors as determined by the company.

We use artificial intelligence to screen assess or select applicants for this role.

This posting is for an existing vacancy at Hoffmann-La Roche Ltd.

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.

Required Experience:

Senior IC

Employment Type : Full-Time
Experience: years
Vacancy: 1