- Guidehouse (Boston, MA)
- …program design, implementation, and monitoring services to pharmaceutical, biotechnology, and medical device , companies. We support our clients across the ... multiple projects simultaneously of all varying sizes and durations to ensure quality control and key client's perceived value while supervising, mentoring and… more
- Gilead Sciences, Inc. (Washington, DC)
- …accelerate development and approval timelines. Provide guidance to PDM Teams and Device Teams to align development and regulatory path for combination products and ... Cultivate strong, collaborative relationships across Gilead's global functions, including Quality , Manufacturing, Technical Development, Clinical Development, and Supply Chain.… more
- Abbott (Pleasanton, CA)
- …levels in the organization. + Minimum of ten (10) years' experience in medical device development and/or other highly regulated industry + Previous experience ... with quality . You will work closely with cross-functional peers in quality , operation, marketing, clinical and regulatory, medical affairs, commercials to… more
- Ankura (New York, NY)
- …and pharmacy benefit management companies, as well as pharmaceutical and medical device manufacturers. Responsibilities: + Applies clinical experience and ... counsel during internal and externally driven investigations through the evaluation of medical records, the determination of medical necessity and appropriate … more
- Olympus Corporation of the Americas (Westborough, MA)
- …+ Excellent understanding of the typical functional roles and responsibilities in medical device organizations + Demonstrated ability to work cross-functionally, ... Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill… more
- Olympus Corporation of the Americas (Westborough, MA)
- …+ Excellent understanding of the typical functional roles and responsibilities in medical device organizations + Demonstrated ability to work cross-functionally, ... live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care...the inorganic strategy goals. They are accountable for a high- quality due diligence report and integration strategy/plan, and to… more
- Abbott (St. Paul, MN)
- …and market success. + **Technical & Regulatory Acumen** : Deep understanding of medical device standards and regulatory frameworks (eg, IEC 60601, IEC 62304, ... spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues… more
- Lilly (Indianapolis, IN)
- …* Six Sigma Green Belt or Black Belt certification * Knowledge in quality systems, insulin/API and fill/finish operations, device assembly and packaging * ... for delivering new and renovated capital assets worldwide. These assets support medical innovation, enhance supply chain robustness, and expand the availability of… more
- United Therapeutics (Hartford, CT)
- …), livers ( **miroliver(R)** ), and a bioengineered external liver assist device for acute liver failure ( **miroliver** **_ELAP_** **(R)** ), with plans ... of biologic or pharma regulatory experience with a Bachelor's Degree in life sciences, quality , regulatory affairs or a related area of study or 10+ years of… more
- Edwards Lifesciences (San Diego, CA)
- …including expert understanding of US GAAP and SEC reporting standards + Medical Device industry experience highly preferred + International entity exposure ... play a fundamental role in how we impact the quality of life for patients all over the world....for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination… more