Roche Location: Pleasanton, CA
About the job
The Position In this position, you will have an administrative role in registering and addressing affiliate questions for a wide array of innovative medical diagnostic products for researchers, physicians, patients, hospitals, laboratories and blood banks in high profile demographic regions, specifically in APAC, LATAM, Middle East and Africa. In addition, you will identify processes that can be improved and simplified by e.g. the use of RPA (Robotic Process Automation).
- Assist in activities associated with regulatory approval of in vitro diagnostic medical devices in global markets
- Provide support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to US and international regulatory requirements
- Responsible for maintenance of product technical files and for ongoing activities related to compliance with global directives and regulations
- Assist in submission activities for a variety of device regulatory approvals including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, export certificates, establishment registrations and listings, etc
- Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects
- Interface with regulatory authorities on regulatory and technical matters, as directed
- May provide regulatory support on project teams
- Assist in the creation of Operating Procedures and policy guidelines
- Assist in review of labeling changes, advertising and promotional activities, etc
- May assist as the internal regulatory consultant for on-market product issues
- Assist in review of proposed device changes
- May perform other duties as required or assigned
- Other duties as assigned by management
We are open to hiring at the Regulatory Affairs Specialist level, or Regulatory Affairs Project Manager level depending on experience.
Minimum Qualifications for Specialist:
- B.S./B.A. in a science, engineering, or related technical field; advanced degree preferred
- 0-5 years experience in regulatory, development, clinical affairs, quality, or program management in IVD, medical device, or pharma industries. Regulatory affairs experience is preferred. IVD device experience is preferred
Minimum Qualifications for Project Manager:
- 5-7 years experience in regulatory, development, clinical affairs, quality, or program management in IVD, medical device, or pharma industries. Regulatory affairs experience is preferred. IVD device experience is preferred
- Experience in Healthcare regulatory affairs
- Can manage high complexity work and/or global projects, or equivalent experience
- Advanced degree is considered an advantage
Additional Preferred Experience:
- Experience with regulatory submissions including IDE, 510(k), and PMA submissions is preferred
- Experience with Robotic Process Automation (RPA) preferred
- Experience working in a cross-functional team setting is preferred
- Regulatory Affairs Certification preferred
Relocation assistance is not available for this opportunity. The expected salary range for this Specialist position based on the primary location of Pleasanton California is $75,000 and $107,000; and for the Project Manager is $96,000 and $137,100. 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.
Who we are At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law. 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. Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
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