- Abbott (Alameda, CA)
- …Qualifications . 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) ... . Support functional groups in the development of relevant data to complete a regulatory submission. .... device regulations and submissions. . Familiar with relevant regulatory requirements for medical devices including Quality… more
- Abbott (Alameda, CA)
- …**Qualifications** + 5 years' experience working with Class II, Class III medical devices and/or biologics/drugs. Regulatory Affairs Certification (RAC) ... project plans and timelines. + Lead functional groups in the development of relevant data to complete a regulatory submission. + Write and edit technical… more
- Beth Israel Lahey Health (Boston, MA)
- …Manager of Business and Regulatory Affairs oversees financial performance, regulatory compliance, and data management of the Heart Transplant, LVAD and ... Responsibilities:** 1. Works with the Heart Transplant Director and Medical and Surgical Directors to develop business plans and...adequate electronic systems are in place to capture the data required for submission to regulatory required… more
- Medtronic (Santa Rosa, CA)
- …This position will be based in Santa Rosa, CA. The **Senior Regulatory Affairs Specialist** develops strategies for worldwide product registration with ... in a technical discipline + Minimum 4 years of medical device regulatory experience + Or minimum...our walls. **Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data , and automation. You're shaping the future of healthcare… more
- Stryker (Cary, IL)
- Stryker is hiring a **Senior** ** Regulatory ** ** Affairs ** **Specialist** to join our Sage ... + Tracks and submits required reports/notifications during clinical research and ensures data supports regulatory strategy and product claims. **What you need:**… more
- Otsuka America Pharmaceutical Inc. (Atlanta, GA)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... business units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, … more
- Organon & Co. (Jersey City, NJ)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Scientist (Associate Director) is responsible for developing and implementing Regulatory Chemistry, Manufacturing & Controls (CMC) strategies for assigned small… more
- Edwards Lifesciences (Irvine, CA)
- …difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex ... Prepare, provide direction and oversee documentation packages for submission to global regulatory agencies. Prepare GUIDID submission data . Track timelines and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …a scientific or technical discipline required (advanced degree preferred) - with biopharma and/or regulatory affairs experience of 14+ years with a BA/BS or 12+ ... data architecture, and data engineering, for example, standardization of data per regulatory authorities (eg, ALCOA, DSAB) + Knowledge of data… more
- Henkel (Westlake, OH)
- Product Safety and Regulatory Affairs Specialist **_About_** **_this_** **_position_** At Henkel, you'll be part of an organization that's shaping the future ... in applicable SBU and region, incl preparation of Safety Data Sheets and labels data + Identifies,...and processes Leads regional and global product safety and regulatory affairs projects to simplify, harmonize and… more