Regulatory Affairs Manager - International CDx

Roche; Pleasanton (CA); On-site; USD 106,000 - 197,000; Full time

Job summary

Roche is seeking an International Regulatory Affairs Manager to support high quality submissions for IVDs worldwide, including companion diagnostics. You will collaborate with cross‑functional teams, manage registrations, and maintain licenses across markets with a focus on Health Authority interactions.

You should bring substantial regulatory experience, knowledge of global requirements, and the ability to influence strategic directions in a complex, multinational environment.

Qualifications

• Experience in Regulatory Affairs with IVDs/medical devices.
• Knowledge of international regulatory requirements (US/EU/others).
• Ability to lead global regulatory projects and communicate clearly.

Responsibilities

• Secure regulatory approvals for products by collaborating with cross-functional teams across defined markets.
• Coordinate and compile submission deliverables to keep registrations on track with timelines.
• Maintain product licenses throughout their life cycle and manage health authority notifications.
• Drive regulatory strategy efficiency by partnering with internal and external stakeholders.
• Provide strategic regulatory input based on international requirements and global submissions.

Skills

Regulatory Affairs

Quality management

Global project leadership

Education

PhD in a related field

Masters in a related field

Bachelor in a related field

Job description

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

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

As an International Regulatory Affairs Manager you will be a member of the CDx International Regulatory Subchapter. In this position you will focus on the support and delivery of high quality regulatory submissions of IVDs (including companion diagnostics) to Health Authorities worldwide (ex-US/EU).

The Opportunity

• You will secure regulatory approvals for products within your area of responsibility by collaborating closely with cross-functional teams across defined markets.

• You will coordinate and compile submission deliverables in a timely manner to ensure all product registrations stay on track with planned timelines.

• You will maintain product licenses throughout their entire life cycle, managing successful Health Authority notifications and submissions in strict accordance with quality management change control processes.

• You will drive the efficiency and success of regulatory strategies by fostering strong partnerships with internal stakeholders and external entities, including Health Authorities and Notified Bodies.

• You will provide strategic regulatory input based on international requirements and directly support global submissions by managing data, addressing Health Authority inquiries, and keeping international affiliates informed of key project updates.

• You will serve as a subject matter expert, ensuring that complex regulatory requirements and strategic goals are clearly communicated, implemented, and kept transparent across the organization.

Who you are

• You have 3-5 years experience with PhD degree, 5-7 with Masters degree and 6-8 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent.

• You have demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.

• You have knowledge of the European, US, China and other international regulations and demonstrated ability to adequately interpret and implement quality standards.

• You have demonstrated the ability to manage more complex work and/or at parts of global projects.

Preferred

• Experience in companion diagnostics is a plus.

Locations

For this role, you can be based in Tucson, Branchburg, Carlsbad, Indianapolis, Pleasanton or Santa Clara. This is an onsite position.

Relocation Assistance is not available for this opportunity.

The expected salary range for this position based on the primary location of Arizona is between $106,100 and $197,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits (https://roche.ehr.com/default.ashx?CLASSNAME=splash)

Who we are

A healthier future drives us to innovate. Together, more than 100’000 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.

Let’s build a healthier future, together.

Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (https://docs.google.com/forms/d/e/1FAIpQLSdZWlsbfQOvFVIQgHE_iDzWUTlhZvj6FytIzjS7xq6IGh1H5g/viewform) .