- ThermoFisher Scientific (Rochester, NY)
- …least 2 years of experience in a regulated industry (pharmaceutical or medical device ). **Preferred Qualifications** + Familiarity with product stewardship, ... regulations (EU REACH, CA Prop 65, TSCA). + Understanding of pharmaceutical and medical device standards and regulations (USP, ISO 10993, ISO 13485, IVDR,… more
- Grifols Shared Services North America, Inc (Manhattan, NY)
- …submissions. + May supervise staff + May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of ... more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has… more
- United Therapeutics (Albany, NY)
- …), livers ( **miroliver(R)** ), and a bioengineered external liver assist device for acute liver failure ( **miroliver** **_ELAP_** **(R)** ), with plans ... hearts. **Who you are** We are looking for a regulatory strategist who will advise on regulatory ...in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee… more
- Nissha Medical Technologies (Buffalo, NY)
- …Product Introduction (NPI) will lead the successful onboarding and ramp-up of new medical device programs within a contract manufacturing environment. This role ... Sciences, or related field (Master's or MBA preferred). + 10+ years of experience in medical device manufacturing, with at least 5 years leading NPI or project… more
- Oura (New York, NY)
- …we are compliant with the applicable standards and regulations governing the development of medical device software at Oura. This role will demand a sense of ... will do: + Define project scope, goals, and deliverables in collaboration with Medical Device Team, Oura's SaMD feature development team Product Manager, senior… more
- LSI Solutions (Victor, NY)
- …in 1986, located in beautiful Victor, New York, is a dynamic and growing medical device company with over 500 employees dedicated to advancing minimally invasive ... We are searching for passionate people looking to make a difference in the medical device industry. By joining LSI SOLUTIONS(R) an ISO 13485 certified company,… more
- LSI Solutions (Victor, NY)
- …in 1986, located in beautiful Victor, New York, is a dynamic and growing medical device company with over 500 employees dedicated to advancing minimally invasive ... We are searching for passionate people looking to make a difference in the medical device industry. By joining LSI SOLUTIONS(R) an ISO 13485 certified company,… more
- Cordis (New York, NY)
- …treatments for coronary and peripheral artery diseases. With four Investigational Device Exemptions (IDEs) approved and actively enrolling patients (Coronary ISR, ... SFA, and Peripheral BTK), Cordis is leading the way in delivering transformative medical solutions. At Cordis, we're teammates, not just employees. We embrace an… more
- Bassett Healthcare (Cooperstown, NY)
- …optimum health and enjoy the best quality of life possible. What you'll do The Medical Office Assistant III serves as the first point of contact for patients within ... sure the patients needs are met) or prescription requests using the electronic medical record messaging system as observed by Supervisor and reported by providers… more
- LSI Solutions (Victor, NY)
- …in 1986, located in beautiful Victor, New York, is a dynamic and growing medical device company with over 500 employees dedicated to advancing minimally invasive ... We are searching for passionate people looking to make a difference in the medical device industry. By joining LSI SOLUTIONS(R) an ISO 13485 certified company,… more