Hybrid 88-50101965 Regulatory Affairs Manager bei Roche

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

Roche Sequencing Solutions, Inc. seeks a Regulatory Affairs Manager at its Santa Clara, CA location.

Duties: As an individual contributor, develop strategies and submissions for regulated software products to gain approvals for commercial distribution and clinical research following SW regulations and standards. Work with the cross-functional teams to develop a strategy for complex medical device software products (e.g., product requirements, clinical trials, regulatory communications, and submissions) and communicate status updates and potential issues regarding plans, regulations, and stakeholders. Prepare regulatory dossiers required for regulatory registration and license applications. Coordinate FDA Pre-submission to obtain the agency’s feedback on the data required to support the marketing authorization application. Support internal/external audits and regulatory inspections; and foster positive effective working relationships with regulatory agencies. Telecommuting permitted up to 3 days per week.

Education and experience required: Bachelor’s degree, or foreign equivalent degree, in Regulatory Affairs, Biomedical Engineering, Engineering or related field and 5 years of progressive, post-baccalaureate experience as a Regulatory Affairs Manager/Lead/Principal RA Specialist or related position

Special Requirements: Position requires any amount of experience with each of the following: 

• Regulatory submissions

• Developing regulatory strategies for regulated software products 

• Medical Device SW regulation and standards (ISO 13485, IEC 62304, IEC 14971, and IEC 62366) 

• FDA pre-submissions

• Working with cross-functional teams for complex medical device software products

The expected salary range for this position based on the primary location for this position of California is $187,488 to $222,000 per year. Actual pay within the range 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)

Worksite: 2881 Scott Blvd., Santa Clara, CA 95050

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.

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