- Abbott (Alameda, CA)
- …their glucose levels with our new sensing technology. **The Opportunity** This ** Senior International Regulatory Operations Specialist** will work on-site ... and territorial trade requirements, agreements and considerations + Domestic and international regulatory guidelines, policies and regulations + Ethical… more
- Abbott (Alameda, CA)
- …place to work for diversity, working mothers, female executives, and scientists This ** Senior Regulatory Operations Specialist** will work on-site out of our ... Opportunity** As an individual contributor, the function of a ** Senior Regulatory Affairs Specialist** is to provide...and requirements GxPs (GCPs, GLPs, GMPs) + Domestic and international regulatory guidelines, policies and regulations +… more
- Abbott (Alameda, CA)
- …place to work for diversity, working mothers, female executives, and scientists This ** Senior Regulatory Operations Specialist** will work out of our Alameda, CA ... Opportunity** As an individual contributor, the function of a ** Senior Regulatory Affairs Specialist** is to provide...and requirements GxPs (GCPs, GLPs, GMPs) + Domestic and international regulatory guidelines, policies and regulations +… more
- Stryker (Fremont, CA)
- …We are currently seeking a ** Senior Regulatory Affairs Specialist** to join Stryker Neurovascular's International ... and inspires others. **What you will do** As the ** Senior Regulatory Affairs Specialist** , you will...into project plans and timelines. + Develop a centralized international regulatory requirements matrix regarding OEMs and… more
- Abbott (Santa Clara, CA)
- …imaging catheters and software, vessel closure devices and peripheral stents. This ** Senior Regulatory Affairs Specialist** position is an on-site opportunity ... Division. As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide...such preparation. **WHAT YOU'LL DO** **Strategic Planning:** + Provide regulatory input to product lifecycle planning. +… more
- Abbott (Santa Clara, CA)
- …guidance on regulatory requirements to development teams + Prepare robust regulatory applications (FDA and international regulatory agencies) to achieve ... and software, vessel closure devices and peripheral stents. This ** Regulatory Affairs Senior Manager** position is an...area + Previous experience with PMA / IDE and international submissions + Experience with combination product … more
- Stryker (Fremont, CA)
- …We are currently seeking a ** Senior Staff Regulatory Affairs ... to continuously improve. **What you will do** As the ** Senior Staff Regulatory Affairs Specialist** , you..., you will be core team member of new product development team and review advertising and promotional materials.… more
- BeiGene (San Mateo, CA)
- …ensure the quality management process is in place and executed to ensure the product quality is compliant with regulatory requirements and BeiGene standards. + ... and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. The role has global responsibility… more
- Amazon (Sunnyvale, CA)
- …of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements. * Develops global ... lifecycle for medical devices. Key job responsibilities * Acts as a regulatory representative on core product development teams, communicates regulatory … more
- Ascendis Pharma (Palo Alto, CA)
- …teams and sub teams across international site locations. + Provides regulatory information and guidance for product development and planning throughout the ... international participants. May mentor and potentially supervise other regulatory professionals working on the project team and ...reports. + Work is performed under direction of a Senior Regulatory Affairs professional. + Contribute to… more
- Abbott (Alameda, CA)
- …live a full life. You'll also have access to: + Career development with an international company where you can grow the career you dream of. + Free medical coverage ... guidance for the design and development of company products. Works closely with product development team to establish product development goals while ensuring… more
- Ascendis Pharma (Palo Alto, CA)
- …and those of direct reports . Work is performed under direction of a Senior Regulatory Affairs professional Contribute to internal regulatory policies and ... with international participants. May mentor and potentially supervise other regulatory professionals working on the project team and regulatory … more
- Cisco (San Jose, CA)
- …timelines and coordinating content till RTB. * Review and communicate current regulatory requirements for compliance for US and international regulations * ... and trade team conversations where applicable. * Develop and execute global regulatory strategies for manufacturing fulfillment across one or more programs. * Lead… more
- Gilead Sciences, Inc. (Foster City, CA)
- …the Biologics portfolio across external network partners. + Contribute to Annual Product Quality Reviews, Regulatory Filings, and responses to Information ... to the QC team for timely project completion and regulatory compliance. **FOCUS AREAS** You Will: + Oversee the...large cross functional projects, often with high visibility to senior management within the organization or with international… more
- Abbott (Santa Clara, CA)
- …of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE ... live a full life. You'll also have access to: + Career development with an international company where you can grow the career you dream of. + Free medical coverage… more
- Abbott (Pleasanton, CA)
- …implantable medical device software development. + Strong knowledge of FDA and international regulatory requirements for medical device software **WHAT WE ... also have access to: + Career development with an international company where you can grow the career you...existing products. Will work with cross-functional teams - Quality, regulatory , EE, Systems, product performance group, and… more
- Abbott (Pleasanton, CA)
- …114,000 colleagues serve people in more than 160 countries. **Job Title** ** Senior Quality Engineer, Software** **About Abbott** Abbott is a global healthcare ... also have access to: + Career development with an international company where you can grow the career you...Abbott's design control requirements and state of the art product standards. The **_Senior Quality Engineer, Software_** will serve… more
- GRAIL (Menlo Park, CA)
- …safety issues, clinical safety data, interactions with domestic and international regulatory departments/agencies, and strong collaborative and networking ... and other teams across GRAIL to implement a safety program that assures regulatory compliance, product quality and patient safety **Responsibilities** + Be… more
- Abbott (Alameda, CA)
- …Quality/ Regulatory /Operations professionals to drive the successful execution of product related, on market change projects + Prioritize activities across ... also have access to: + Career development with an international company where you can grow the career you...professionals measure, track and analyze glucose levels. As a Senior Project Leader, you will be involved in planning,… more
- Abbott (Alameda, CA)
- …live a full life. You'll also have access to: + Career development with an international company where you can grow the career you dream of. + Free medical coverage ... the way people monitor their glucose levels with our new sensing technology. Our Senior Electrical Engineer works independently in a lead role, or as part of a… more