At a Glance
- Tasks: Lead global medical compliance oversight and manage critical compliance topics across Roche Pharma and Diagnostics.
- Company: Roche values personal expression and aims to cure diseases while ensuring healthcare access for all.
- Benefits: The expected salary range is €136,936.00 to €179,728.50 based on experience and qualifications.
- Other info: Relocation benefits are not available for this position.
- Why this job: Join Roche's Global Quality team to shape medical compliance and drive data-driven insights.
- Qualifications: Requires 7+ years of experience and a degree in a scientific or quality-related field.
The predicted salary is between 136936 - 179728 £ per year.
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.
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:
- 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.
Qualifications:
- 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.
Relocation benefits are not available for this job posting. The expected salary range for this position based on the primary location of Mississauga is €136,936.00 to €179,728.50. Actual pay will be determined based on experience, qualifications, and other job-related factors as determined by the company. Roche is an Equal Opportunity Employer.
Senior Medical Compliance Lead in Welwyn employer: Roche
Roche, located in Mississauga, offers a culture that embraces individuality and encourages open dialogue. The company is committed to quality in Pharma Development and values every voice in its mission to improve healthcare access globally.