- Envista Holdings Corporation (Brea, CA)
- …teams to fulfill regulatory requirements for product registration and compliance . + Review and evaluate product, manufacturing, and labeling changes ... procedures, standard operating procedures (SOPs), and technical documentation to support regulatory compliance and operations. + Collaborate with global… more
- Sumitomo Pharma (Sacramento, CA)
- …, and approval of promotional materials, eg Marketing and their Agencies, Legal, Compliance , and Medical Affairs. + Provide appropriate oversight of promotional ... encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and… more
- Edwards Lifesciences (Irvine, CA)
- …matter specific projects) + Close collaboration with various cross functional teams including Medical , Legal and Regulatory review of Advertising and ... potential legal risks. This role requires deep knowledge of global medical device-industry, including the regulatory landscape, authorities and frameworks,… more
- Abbott (Alameda, CA)
- …regulatory submission. + Write and edit technical documents. + Administer/meet regulatory requirements to achieve excellent compliance status with no ... enforcement actions. + Negotiate with regulatory authorities during the development and review ... review process to ensure submission approval. + Review and approve labeling to ensure compliance .… more
- Unilever (El Segundo, CA)
- …The Sr. Director will serve as the driving force behind regulatory compliance initiatives, thought leadership, and cross-functional collaboration. They ... compliance in a rapidly scaling business. + Global Regulatory Partnership: Lead the regulatory compliance...conferences, and with government agencies. + Product & Brand Compliance : + Oversee and optimize the review … more
- Abbott (Alameda, CA)
- …issues + Work closely with in-country regulatory representatives, compile, prepare, and review medical device or IVD submissions to regulatory agencies ... requirements + Review product labeling and promotional materials to ensure compliance with relevant regulatory requirements. + Provide regulatory support… more
- Abbott (Santa Clara, CA)
- …across the medical device businesses. **What You'll Work On** + Review regulatory submissions involving software components (eg, 510(k), PMAs, CE marking, ... compliance strategies. Assists management and leadership on regulatory activities and works with the medical ...products especially with FDA + Supports and provide critical review of key documents necessary for regulatory … more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance , consistency, and accuracy + Provide ... inclusion in regulatory submissions. May interact with regulatory agencies as part of submission review ...product and process changes, and product documentation to assure regulatory requirement's compliance , consistency, and accuracy +… more
- BeOne Medicines (San Mateo, CA)
- … regulatory requirements and company policies/standards. + May also perform regulatory review for non-promotional medical , HEOR, and corporate/investor ... and consistency with approved labeling. **Essential Functions of the Job:** + Performs regulatory review for promotional materials in conformance with local… more
- Abbott (Alameda, CA)
- …edit technical documents. . Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions. . Review and approve ... with outside regulatory agencies and trade associations, develop innovative regulatory compliance strategy, and provide executive management with … more