- Edwards Lifesciences (Irvine, CA)
- … strategic plans + Prepare and oversee documentation packages for submission to global regulatory agencies. Assist with GUDID submissions. Track timelines and ... Class II and/or Class III devices + Full knowledge and understanding of global regulatory requirements (US, EU, and Health Canada) for new products or product… more
- Boehringer Ingelheim (Ridgefield, CT)
- …and briefings to global and regional policy management on relevant global regulatory policy issues. + Participate in internal product team meetings ... development activities and on existing development strategies. + Lead requests for global country-level regulatory information from various partners. + Handle… more
- Caldera Medical (Westlake Village, CA)
- …and audits in a timely and professional manner. * Maintain up-to-date knowledge of global regulatory requirements and assess their impact on current and future ... and country-specific submissions. * Experience working with Notified Bodies and global regulatory agencies for product approvals and compliance matters… more
- Stryker (Tempe, AZ)
- …Affairs** is a key strategist, responsible for developing and executing the global regulatory strategy for **Stryker Sustainability Solutions (SSS)** business ... **Key Areas of Responsibility:** + Develops the organization's national, regional, and global regulatory position(s) and strategy based upon assessment and… more
- Citigroup (Getzville, NY)
- …Responsibilities: Contributes to the engagement and oversight of Citi's Finance global regulatory agenda, including: + Centrally coordinates Citi's Finance ... **About the Team** The Finance Regulatory Engagement & Oversight team works closely with... global regulatory agenda to help manage and/or support on-site or… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …establish Regulatory Requirements. + Support development and execution of global regulatory strategies by collaborating closely with international ... regulatory submissions (Qsub, PMA, 510(k), IDE) to FDA and other global regulatory agencies and experience negotiating with regulatory authority personnel… more
- Roche (Indianapolis, IN)
- …we all have more time with the people we love. That's what makes us Roche. At Global Regulatory Affairs our aspiration is to be the world's best Regulatory ... Germany, Switzerland and the US within and across chapters as well as with global Regulatory Affairs teams, especially in China and Japan. **Who You Are** + You… more
- Amazon (Arlington, VA)
- …admitted into the US as a refugee or granted asylum. About the team The Global Regulatory Affairs team is responsible for enabling and protecting Kuiper's use of ... a unique opportunity to assist in the development of a global broadband communication system. As a Regulatory Engineer, you will: * Work on complex regulatory… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …inputs (including all documents required under risk files.) + Knowledge of global Regulatory Affairs requirements, regulations, and standards + Strong ... Devices along with associated Software and Accessories on a global basis from a Regulatory Affairs standpoint. Support will consist of new product development,… more
- AbbVie (North Chicago, IL)
- …& Development (R&D) organizations. Represents CMC on teams such as product development, Global Regulatory Product Teams and Operations brand teams to negotiate, ... regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates… more