88-50101965 Regulatory Affairs
Apply NowCompany: Roche
Location: San Jose, CA 95123
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
Roche Sequencing Solutions, Inc. seeks a Regulatory Affairs at its San Jose, CA location.
Duties: Support development of submission/product registration dossiers of complex products/programs. Develop comprehensive global regulatory submissions and registration plans. Effectively partner with stakeholders to understand and provide best solutions. Address problems or opportunities and involve stakeholders for best solutions. Develop external relationships that significantly influence the current and future direction for Roche and our products. Actively contribute to audit preparation and potentially in audit discussions. Ensure organization adapts to evolving regulatory environment and requirements. Solve complex, critical health authority issues or equivalent. Understand external environmental changes and precedents to navigate complex situations and influence strategies and decision making. Interpret and apply understanding of regulators' thinking to projects, and apply strategies to the varying needs of different regions. Proactively create unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate worldwide approvals. Cultivate and utilize relationships that influence the current and future direction for Roche and our products. Challenge and resolve complex issues and overcome organizational barriers. Drive innovation across the organization/sites. Advocate for and help to progress new ideas that add business value. Drive new ideas into the business. Actively develop VACC competencies and deploy them in daily work. Apply technical expertise to lead innovation and mobilize the organization. Express complex ideas fluently and clearly, recognizing and articulating multiple points of view on an issue.
Education and experience required: Bachelor's degree or foreign equivalent in Science, Engineering, or related technical field and 5 years of progressive, post-baccalaureate experience in the job offered or related position in pharmaceutical or medical device industry.
Special Requirements: Must have two (2) years of experience with each of the following:
May telecommute from anywhere in the US.
A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at https://roche.ehr.com/default.ashx?CLASSNAMEsplash
Worksite: 5945 Optical Court, San Jose CA, 95138
The expected salary range for this position based on the primary location for this position of San Jose California is $155,640 to $193,100. 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 )
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.
The Position
Roche Sequencing Solutions, Inc. seeks a Regulatory Affairs at its San Jose, CA location.
Duties: Support development of submission/product registration dossiers of complex products/programs. Develop comprehensive global regulatory submissions and registration plans. Effectively partner with stakeholders to understand and provide best solutions. Address problems or opportunities and involve stakeholders for best solutions. Develop external relationships that significantly influence the current and future direction for Roche and our products. Actively contribute to audit preparation and potentially in audit discussions. Ensure organization adapts to evolving regulatory environment and requirements. Solve complex, critical health authority issues or equivalent. Understand external environmental changes and precedents to navigate complex situations and influence strategies and decision making. Interpret and apply understanding of regulators' thinking to projects, and apply strategies to the varying needs of different regions. Proactively create unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate worldwide approvals. Cultivate and utilize relationships that influence the current and future direction for Roche and our products. Challenge and resolve complex issues and overcome organizational barriers. Drive innovation across the organization/sites. Advocate for and help to progress new ideas that add business value. Drive new ideas into the business. Actively develop VACC competencies and deploy them in daily work. Apply technical expertise to lead innovation and mobilize the organization. Express complex ideas fluently and clearly, recognizing and articulating multiple points of view on an issue.
Education and experience required: Bachelor's degree or foreign equivalent in Science, Engineering, or related technical field and 5 years of progressive, post-baccalaureate experience in the job offered or related position in pharmaceutical or medical device industry.
Special Requirements: Must have two (2) years of experience with each of the following:
- Applying US FDA Assay Migration Guidance and Reagent Replacement and Instrument Family Policy;
- Supporting global medical device registration in compliance with Global Medical Device Regulations
- U.S. regulatory submissions in compliance with 21 CF Regulations for in vitro diagnostic (IVD) devices;
- Supporting in vitro diagnostic (IVD) product development projects with regulatory strategies and guidance;
- Analyzing and resolving complex regulatory submission issues.
May telecommute from anywhere in the US.
A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at https://roche.ehr.com/default.ashx?CLASSNAMEsplash
Worksite: 5945 Optical Court, San Jose CA, 95138
The expected salary range for this position based on the primary location for this position of San Jose California is $155,640 to $193,100. 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 )
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.