- Abbott (Santa Clara, CA)
- …executives, and scientists. **The Opportunity** We currently have several opportunities for the ** Medical Device Regulatory Affairs Development (RAD) ... to various international affiliates. + Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are… 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
- Amazon (Sunnyvale, CA)
- …as part of the Medical Devices Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to build best in class products. ... verbal, presentation, and organizational skills. - . Experience with medical device software requirements. - . Ability...dollar businesses and reporting to senior leadership - . Regulatory Affairs Certification (RAPS) - . Drug… 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
- Stryker (San Jose, CA)
- … Affairs or RAC certification preferred + 1-2 years of regulatory affairs experience within the medical device industry + Knowledge of FDA and ... available at www.stryker.com We are currently seeking a **Senior Regulatory Affairs Specialist** to join our **Endoscopy...international medical device regulations and standards (eg EU MDR) preferred $97,900.00… more
- Abbott (Pleasanton, CA)
- …mothers, female executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager** to join Abbott's Heart Failure Division on-site ... CA. As an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge... regulations and/or experience with EU and other international medical device regulations and submissions. + Ability… more
- Kelly Services (Sunnyvale, CA)
- Kelly(R) Science & Clinical is seeking a Regulatory Affairs Process Specialist for a one-year contract opportunity with a leading molecular diagnostics company ... Remote US (Pacific and Central Time preferred **)** **Position Title:** Regulatory Affairs Process Specialist **Position Type:** One-year contract with… 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 (Alameda, CA)
- …medical devices + Assess the acceptability of documentation for medical device submissions and effectively communicate regulatory guidance + Assist in SOP ... diversity, working mothers, female executives, and scientists This **Senior Regulatory Affairs Specialist** will work on-site out...regulatory requirements for Class II software … more
- AbbVie (Pleasanton, CA)
- …regulatory requirements and communicates planned/approved changes with operations, commercial, medical affairs and marketing. 2. Advisory Responsibilities * ... biology or other health sciences; plus five-year experience in regulatory affairs . + At least three-year experience.... + At least three-year experience working in a medical device manufacturing company, preferably with capital… more
- BeiGene (San Mateo, CA)
- The Executive Director of Regulatory Affairs , Companion Diagnostics (CDx) will be responsible for developing, advising on and executing global regulatory ... evolving industry standards. **Qualifications:** + Bachelor's, Master's, or PhD in Life Sciences, Regulatory Affairs , or a related field. Regulatory … more
- Abbott (Alameda, CA)
- …**Qualifications** + 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) ... US drug regulations or with EU and other international medical device regulations and submissions. + Familiar...device regulations and submissions. + Familiar with relevant regulatory requirements for medical devices, drugs and/or… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …your best self. Become a **maker of possible** with us. The Senior Director, Medical Affairs and Clinical Execution will have an extensive background in clinical ... organization, working closely with other functions within BD Biosciences, including regulatory affairs , quality, R&D, marketing and commercial functions. This… more
- Veterans Affairs, Veterans Health Administration (Palo Alto, CA)
- …clinical and laboratory prosthetic and orthotic services to disabled patients at Veterans Affairs Palo Alto Health Care System. These type of services include work ... levels. (2) Serving as an advisor to physicians, therapists, and other medical professionals with regard to indications and contraindications of prosthetic and… 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 ... help people with chronic pain or movement disorders, our medical device technologies are designed to help... regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of… 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 (Alameda, CA)
- … Events Team provides direct supervision and management to staff responsible for filing Medical Device Reports to the FDA (US), Medical Problem Reports ... Incident Reports to the EU/EFTA including France, and Medical Device Incident reports to the rest...within established timeframes. Elevates complaints requiring ADC Management and Medical Affairs guidance, participates in discussions and… more
- Abbott (Pleasanton, CA)
- …for diversity, working mothers, female executives, and scientists. For years, Abbott's medical device businesses have offered technologies that are faster, more ... help people with chronic pain or movement disorders, our medical device technologies are designed to help...Keep commercial organization and other internal functions (eg, Clinical, Regulatory Affairs , R&D) informed about the potential… more
- ThermoFisher Scientific (San Jose, CA)
- …and user experience. + Stay current with industry trends, standard processes, and regulatory requirements related to medical device development. **Risk ... + Strong understanding of regulatory requirements and quality systems for medical device development (eg, FDA, ISO). + Exceptional leadership, communication,… more