Regulatory Affairs Manager

Roche Holdings Inc.; Indianapolis (IN); Remote; USD 104,000 - 193,000; Full time

Job summary

A global healthcare company is seeking a Regulatory Affairs professional in Indianapolis, Indiana. This role entails managing regulatory submissions for in-vitro diagnostics across various regions, requiring a strong background in regulatory affairs and collaboration within international teams. Candidates should have a relevant degree and significant experience in the medical device or IVD sector. The position offers a competitive salary range of $104,000–$193,000, and may allow for remote work under certain conditions.

Qualifications

• 3-5 years regulatory experience with a PhD, 5-7 years with a Master's, or 6-8 years with a Bachelor's in IVDs/Medical devices.
• Technical understanding of medical devices or IVDs.
• Knowledge of immunoassays and international regulations.

Responsibilities

• Provide strategic direction and representation in regulatory teams.
• Manage product registrations in multiple regions.
• Prepare and submit submissions to regulatory bodies.

Skills

Regulatory Affairs Experience

Project Management

Independent and Flexible Work

Collaboration

Education

Bachelor's/Master's in Life Science or related

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.

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.

At Global Regulatory Affairs, our aspiration is to be the world's best Regulatory organization, championing patient access to the world's best diagnostics. Focus of our work is the global approval of in-vitro-diagnostics of the Elecsys immunoassay product portfolio. Our dynamic team manages regulatory projects as well as overarching regulatory topics.

The Opportunity

• Provide strategic direction and representation of Regulatory Affairs in international and interdisciplinary teams in order to create an impactful and fruitful work environment.
• Manage neurology, cardiology, and core reagents product registrations in the United States, Europe, and China and support worldwide registrations.
• Give regulatory guidance on both strategic and tactical topics to stakeholders and cross-functional project teams of the appropriate customer areas.
• Prepare and submit premarket submissions to FDA or Notified bodies serving as the primary interface. Interact with regulatory agency personnel in order to expedite approval or clearance of pending registration and answer any questions.
• Be accountable for supporting product care activities and updating the technical documentation of the product portfolio.
• In order to achieve efficient approvals worldwide, you work in close collaboration with colleagues in Germany, Switzerland, and the US within and across chapters as well as with global Regulatory Affairs teams, especially in China and Japan.

Who You Are

• You have a Bachelor's / Master degree in Life Science, Data Science, or a related subject or equivalent experience. Advanced degree preferred.
• You have 3-5 years of experience with a PhD degree, 5-7 with a Master's degree, and 6-8 years with a Bachelor's degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent.
• Technical understanding of medical devices or IVDs.
• In-depth knowledge of immunoassays is highly desirable.
• Knowledge in international laws and regulations for development, manufacturing, and registration of IVDs, especially in EU, US, and China.
• The ability to work independently, reliably, and with exceptional flexibility, allowing you to effectively shift priorities and balance multiple commitments.
• Proven experience in managing overlapping projects, showcasing your strong ability to juggle multiple tasks, multitask efficiently, and maintain excellent self-organization.
• A collaborative spirit, recognizing and valuing the contributions of your teammates and peers, and leveraging strong relationships to achieve key results.

Locations

You are local to Indianapolis, Indiana, Mannheim, or Penzberg, Germany. We will consider remote work arrangements under extraordinary circumstances.

Relocation assistance is not available for this position.

The expected salary range for this position based on the primary location of Indiana is $104,000-$193,000. 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.

Benefits

A healthier future drives us to innovate. Together, more than 100,000 employees across the globe are dedicated to advancing science, ensuring everyone has access to healthcare today and for generations to come.

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.