- Abbott (Santa Clara, CA)
- …with diabetes from routine fingersticks. We currently have several opportunities for the ** Medical Device Regulatory Affairs Development (RAD) Program** ... CA, Minneapolis, MN or Plano, TX. This position is included in the ** Medical Device Regulatory Affairs Development (RAD) Program** and performs three… more
- Stryker (San Jose, CA)
- …an FDA regulated environment required + Minimum 4 years of full-time work experience in medical device regulatory affairs required + Demonstrated applied ... benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) We are currently seeking a **Senior Staff Regulatory Affairs Specialist** to join our Endoscopy… more
- Abbott (Pleasanton, CA)
- …business unit model. + Experience working in the Medical Device industry. + Regulatory Affairs Professionals Society Certification ... place to work for diversity, working mothers, female executives, and scientists. This ** Regulatory Affairs Specialist** **II** will work out of our Pleasanton,… more
- San Jose State University (San Jose, CA)
- …experience in the following: industry experience in entrepreneurship, drug/ medical device development, data science, regulatory affairs , clinical and ... discipline, and a minimum of 3-5 years related experience in a medical device , pharmaceutical, In Vitro Diagnostics, and/or Clinical Research Organization… more
- Meta (Sunnyvale, CA)
- …software as a medical device (SaMD). **Required Skills:** Head of Medical Devices Regulatory Affairs Responsibilities: 1. Lead project teams for ... **Summary:** Reality Labs is seeking an experienced medical devices regulatory affairs ...product approvals for novel hardware and software as a medical device products for distribution into many… more
- Abbott (Pleasanton, CA)
- …+ Minimum of 5 years' experience working with Class II and/or Class III medical devices. Regulatory Affairs Certification (RAC) is a plus. + ... female executives, and scientists **The Opportunity** We are seeking a **Principal Regulatory Affairs Specialist** to join Abbott's Heart Failure Division… more
- Abbott (Santa Clara, CA)
- …the treatment of structural heart disease. **The Opportunity** We are recruiting for a ** Regulatory Affairs Specialist** to join our team on-site in Santa Clara, ... CA.As an individual contributor, the function of a Regulatory Affairs Specialist II is to provide...+ 2-3 years' experience in a regulated industry (eg, medical products, nutritionals). Regulatory area is preferred… more
- Ascendis Pharma (Palo Alto, CA)
- …workplace for employees to grow and develop their skills. The Associate Director, Regulatory Affairs will be responsible for developing and implementing global ... are technically complex and require extensive interaction with departments outside of regulatory affairs . + Excellent organizational skills and ability to work… more
- Abbott (Santa Clara, CA)
- …catheters and software, vessel closure devices and peripheral stents. This **Senior Regulatory Affairs Specialist** position is an on-site opportunity working ... As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support...in a timely manner. + Experience working in the Medical Device industry. + Certification is a… more
- Abbott (Santa Clara, CA)
- …medical technology, engineering, etc. + 5+ years' experience in Medical Device industry + 1-2 years of regulatory experience. + Effectively communicate, ... the treatment of structural heart disease. **The Opportunity** We are recruiting for a ** Regulatory Affairs Specialist II** to join our team on-site in Santa… more
- Stryker (San Jose, CA)
- …The **Director, Regulatory Affairs ... life-threatening medical conditions or that address unmet medical needs + Leads negotiations with regulatory ...Provide a strategic direction and tactical focus to the Regulatory Affairs organization and influence the direction… more
- Stryker (San Jose, CA)
- …innovative team and culture + Learn about regulations within the medical device industry Opportunities Available As a Regulatory intern at Stryker, you ... departments including R&D Engineering, Supplier Quality, Marketing, and Clinical Affairs to assist in regulatory decision-making and...develop a broad understanding of the medical device industry. + Perform Regulatory Intelligence… more
- Danaher Corporation (Sunnyvale, CA)
- …and medically actionable information on patient care. Essential Responsibilities Scientific & Medical Affairs : + Works with R&D functions to identify and ... with L1 team members, designs and drives execution of medical affairs -related strategic goals and objectives, in... risk assessments for complaints; sign-off on reportability of Medical Device Reports (MDR) + Reviews, updates… more
- Abbott (Santa Clara, CA)
- …for diversity, working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that are faster, more ... disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives… more
- Abbott (Menlo Park, CA)
- …Key Opinion Leaders and various cross-functional teams, including Marketing, R&D, Risk Management, Medical Affairs , Quality and Regulatory Affairs . Work ... ability to effectively integrate information from varied disciplines including Clinical Affairs , Engineering, Marketing and Regulatory Affairs . +… more
- Abbott (Pleasanton, CA)
- …constituencies, Global Marketing, Sales, R&D, Complaint Handling, Technical Support, Clinical Affairs , Regulatory Affairs , Legal, international geographies ... + Working in collaboration with the Product Managers, Clinical Affairs , Scientific Affairs and Field Sales Leadership...education experience or equivalent experience in a Class III medical device company or equivalent. + 6+… more
- Abbott (Santa Clara, CA)
- …by interacting with appropriate personnel, (eg, physicians, engineers, other clinical coordinators, regulatory affairs ). + Write device Instructions For Use ... Experience as a scrub technician during procedures + Experience working with medical device Quality systems and/or regulatory product approval processes +… more
- Olympus Corporation of the Americas (San Jose, CA)
- …directly to the Executive Director, Chief of Staff for Quality Assurance and Regulatory Affairs and drives an internal and external communications strategy for ... Creates and executes a communication strategy to support the Corporate Quality Office and Regulatory Affairs across various platforms to act as a vehicle to… more
- J&J Family of Companies (Santa Clara, CA)
- …on RWE studies to meet regulatory requirements, particularly European Union Medical Device Regulation (EU-MDR) requirements for proactive surveillance. + You ... + You will actively partner with colleagues in MedTech Epidemiology, offshore programmers, Medical Safety, Medical Affairs , Scientific and Clinical … more
- Abbott (Pleasanton, CA)
- …and/or system-level verification + Experience working in new product development of medical device industry + Experience focused on risk management activities ... for regulated medical device , especially with FMEA-style risk assessments...from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs The base pay for this… more