- Edwards Lifesciences (Irvine, CA)
- …Surgical Structural Heart), and other Business Unit or Corporate functions such as Regulatory Affairs, Compliance , and others. + Reviewing and advising on a ... as needed.** **How you'll make an impact:** The Manager, Regulatory Counsel reports to the Senior Director, Regulatory...will be responsible for timely review and analysis of clinical contracts, review and approval of advertising and promotion… more
- System One (Baltimore, MD)
- …of clinical letter development processes, ensuring that all outputs meet strict regulatory and compliance requirements for clinical teams. The ideal ... letters using SmartComm, integrated with GuidingCare. + Ensure all letter templates meet regulatory and clinical team requirements. + Act as SME on the… more
- Boehringer Ingelheim (Ridgefield, CT)
- …and Scientific Communications, clinical operations, translational medicine and clinical pharmacology, and regulatory affairs. This position will require ... Upon completion of the fellowship, the Fellow will become proficient in Regulatory Affairs Advertising and Promotion Compliance through hands-on training and… more
- Fresenius Medical Center (Waltham, MA)
- …key regulatory submissions. + Collaborate with senior leadership in medical/ clinical development, commercial, and other functional areas to align regulatory ... considerations into all stages of product development, including preclinical, clinical /medical, CMC, and post-market phases. + Monitor regulatory trends,… more
- Boehringer Ingelheim (Ridgefield, CT)
- …from various partners. + Handle the development of custom reports to support regulatory compliance and advise strategy. + Collaborate with partners to support ... Scientific Communications, clinical operations, translational medicine and clinical pharmacology, and regulatory affairs. This position...any compliance and process initiatives. + Own the review and… more
- Boehringer Ingelheim (Ridgefield, CT)
- …and Scientific Communications, clinical operations, translational medicine and clinical pharmacology, and regulatory affairs. This position will require ... **Description** The Clinical Development and Medical Affairs Fellow is a...regulatory activities required of an NDA Holder for compliance to FDA requirements for US products in BIPI's… more
- GRAIL (Menlo Park, CA)
- …products, including labeling, promotional materials, product changes, and documentation required for compliance and regulatory approval. + Monitor and report on ... + Support internal and external quality audits. + Ensure compliance with all regulations and laws applicable to GRAIL's...**Experience** + Minimum of 10 years of experience in regulatory , development, clinical affairs, quality, or program… more
- Abbott (Santa Clara, CA)
- … requirements to software systems, including documentation, risk management, and compliance strategies. Assists management and leadership on regulatory ... other members of regulatory and related teams. + Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases… more
- Mohawk Valley Health System (Utica, NY)
- …initiatives and support of patient advocate processes. + Oversee enterprise-wide compliance with ongoing regulatory and accreditation readiness sustaining ... of the response needed. + Collaborates with many other departments to ensure compliance with regulatory information. + Ongoing relationships with DOH, DNV,… more
- Globus Medical, Inc. (Audubon, PA)
- …of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and ... their lives as quickly as possible. **Position Summary** **:** The Manager, Regulatory Affairs, is responsible for preparing, filing and gaining approval of 510(k),… more