- Abbott (Santa Clara, CA)
- …shared across the medical device businesses. **What You'll Work On** + Review regulatory submissions involving software components (eg, 510(k), PMAs, CE ... products especially with FDA + Supports and provide critical review of key documents necessary for regulatory ...critical review of key documents necessary for regulatory submissions for new products or changes to existing… more
- Envista Holdings Corporation (Brea, CA)
- …+ Assemble and maintain CE technical files in accordance with applicable regulatory requirements. + Author, review , and approve Clinical Evaluation Reports ... **Job Description:** The ** Regulatory Affairs Specialist** creates, evaluates and completes ...regulatory requirements for product registration and compliance. + Review and evaluate product, manufacturing, and labeling changes to… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …content. Support regulatory impact assessments for change controls and other Regulatory Affairs/Quality Assurance items from a review and approval level. + ... control (BEC) listing of products for global release per Regulatory Affairs requirements. + Review and approve...global release per Regulatory Affairs requirements. + Review and approve labels, labeling, and promotional materials to… more
- Terumo Neuro (Aliso Viejo, CA)
- …and maintain verbal and written communication with regulatory agencies. + Maintain regulatory files and records. + Review change order documents and assess ... impact of product changes on US, EU, Canada, and/or international regulatory strategy/submissions per MicroVention procedures. + Review promotional material and… more
- Meta (Burlingame, CA)
- …for product changes as required to ensure timely approval for market release. Review significant regulatory issues with manager, as necessary, and resolve ... **Summary:** We're seeking a regulatory affairs specialist to join our medical devices...wearables, and other innovative devices. **Required Skills:** Medical Devices, Regulatory Specialist Responsibilities: 1. Interact directly with FDA and/or… more
- Chemours (Sacramento, CA)
- …lawyers, consultants, industry associations, and local agencies on specific medical regulatory topics. + Coordinate and review customer agreements/contracts with ... Chemours chemistry. Chemours is seeking a Product Stewardship & Regulatory Expert - Medical Applications to join our growing...will report directly to the APM Product Stewardship & Regulatory Manager at our Wilmington, DE location or remote.… more
- Abbott (Pleasanton, CA)
- …and requirements of promotion, advertising and labeling + Interpret and apply regulatory requirements. Compile, prepare, review and submit regulatory ... mothers, female executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager** to join Abbott's Heart Failure Division on-site in… more
- TEKsystems (Westlake Village, CA)
- …documentation meets underwriting and compliance standards (DU, LQA, Fraud, and Regulatory Guidelines) + Accurately review loan documentation and collateral ... Job Description The Loan Review Specialist is responsible for conducting pre-purchase reviews of Conventional, Non-Conforming, FHA, and VA loan files. This role… more
- GRAIL (Menlo Park, CA)
- …regulatory strategy development, product validation, audits, promotional material review , on-market product support, and change control processes. This individual ... and laws applicable to GRAIL's business, providing guidance and recommendations. + Review and approve regulatory strategy documents, regulatory plans,… more
- Abbott (Santa Clara, CA)
- …quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submissions to authorities + Negotiate ... and interact with regulatory authorities during the development and review process to ensure submission approval + Ensure compliance with US and global product… more