- Meta (Burlingame, CA)
- …wrist wearables, and other innovative devices. **Required Skills:** Medical Devices, Regulatory Specialist Responsibilities: 1. Interact directly with FDA and/or ... at reviewer level. All significant issues will be reviewed with the manager 2. Support regulatory compliance activities, including site registration, audits,… more
- Meta (Burlingame, CA)
- …launch and expand our products in global markets by navigating complex regulatory landscapes and driving successful product registrations. **Required Skills:** ... strategies for novel and predicate Over-the-Counter software devices to achieve timely product approvals 2. Prepare, submit, and manage regulatory filings across… more
- J&J Family of Companies (Santa Clara, CA)
- …States of America **Job Description:** We are seeking the best talent for a **Senior Product Security Program Manager ** to join our MedTech Product Security ... role may require up to 20% travel. The Senior Product Security Program Manager for Surgery R&D...security audits (ie HITRUST, SOC2, FedRAMP) + Familiarity with FDA and/or other global regulatory cybersecurity guidance… more
- Medtronic (Santa Rosa, CA)
- … regulatory strategy development with a view through the full product lifecycle. Bringing hands-on expertise in regulatory software development strategies ... will support maintaining a strong foundation for future software product development for the Regulatory Function and...Strategic direction is expected to support a number of regulatory applications which may include, FDA Pre-submissions,… more
- Kelly Services (Anaheim, CA)
- …knowledge of USA and global regulations. + Proven experience interfacing with regulatory bodies such as FDA , Notified Bodies, and Competent Authorities. ... **Director of Quality and Regulatory Affairs** Kelly(R) Science & Clinical is seeking...+ Continuously identify opportunities to improve the Quality System, product quality, simplify processes, and reduce the costs of… more
- Actalent (Vista, CA)
- …+ Manage customer product complaints and ensure timely resolution. + Oversee regulatory submissions including FDA 510(k), CE mark, and other product ... We are seeking a dedicated Quality and Regulatory Affairs Manager to lead and...and filing. + Serve as the primary liaison with FDA and other regulatory bodies. Qualifications +… more
- US Tech Solutions (San Bruno, CA)
- …& Regulatory Agencies (eg, FDA , Notified Bodies, etc.), and regulatory audits. + Performing product qualification and product validation, as ... work experience, and experience with Engineering, Operations, Clinical, Quality, and Regulatory teams for successful product deployments. **Top Daily… more
- Abbott (Pleasanton, CA)
- …partners and peers understand quality system requirements and how they impact product quality and regulatory compliance. + Represents the division within ... on with their lives. As a Senior Quality Compliance Manager , the individual will play a crucial role within...environment. + Comply with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies,… more
- Kelly Services (Sacramento, CA)
- …with cGMP regulations, internal quality standards, and applicable regulatory requirements (eg, FDA , EMA, MHRA). The QA Manager will lead a team in managing ... regulatory affairs, and engineering teams to ensure consistent product quality and continuous improvement. **Responsibilities:** + Perform on-the-floor QA tasks… more
- Cardinal Health (Sacramento, CA)
- …research, industry knowledge, and report generation. + Understand brand-to-biosimilars conversions, FDA regulatory dynamics (eg, drug application submissions and ... proposals for recommended action. + Support research to maintain a pulse on product , supplier, regulatory , and market dynamics; understand how industry trends… more