- Abbott (Santa Clara, CA)
- …submission and approval requirements. + Participate in risk-benefit analysis for regulatory compliance . **Premarket:** + Assess the acceptability of quality, ... Abbott is a global healthcare leader that helps people live more fully...software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite opportunity working… more
- Abbott (Alameda, CA)
- …regulatory submission. + Write and edit technical documents. + Administer/meet regulatory requirements to achieve excellent compliance status with no ... Abbott is a global healthcare leader that helps people live more fully...and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory… more
- Abbott (Alameda, CA)
- …the APAC region. + Develop and advance the organizations policy and procedures for regulatory affairs and compliance to establish a compliant culture. + Utilize ... Abbott is a global healthcare leader that helps people live more fully...+ Review product labeling and promotional materials to ensure compliance with relevant regulatory requirements. + Provide… more
- Abbott (Alameda, CA)
- … specialists + Develop and advance the organizations policy and procedures for regulatory affairs and compliance to establish a compliant culture. + Represent ... Abbott is a global healthcare leader that helps people live more fully...+ Review product labeling and promotional materials to ensure compliance with relevant regulatory requirements. + Provide… more
- Philips (San Diego, CA)
- ** Regulatory Affairs Business Specialist** In this role, you will support regulatory compliance and business objectives for our Image-Guided Therapy Devices ... in reviewing product/solution labeling and related marketing communications to ensure compliance with regulatory guidelines and standards, primarily at the… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …role involves developing and implementing practices for SaMD devices to ensure regulatory compliance , expedition of product clearances and maintain the highest ... **Job Description Summary** As Staff Specialist Regulatory Affairs, you will have a deep understanding...input during the design and development of SaMD, ensuring compliance with applicable standards (eg, IEC 62304, ISO 14971).… more
- Abbott (Santa Clara, CA)
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of ... healthcare , with leading businesses and products in diagnostics, medical...and software, vessel closure devices and peripheral stents. This ** Regulatory Affairs Manager** position is an onsite opportunity working… more
- Edwards Lifesciences (Irvine, CA)
- …make an impact:** + Provide high quality guidance and support to Edwards' on healthcare and medical device regulatory matters, including US and other medical ... device regulatory landscape, Advertising and promotion, Healthcare fraud and abuse, Antitrust, Anti-corruption and the US...in close cooperation with colleagues in the Law and Compliance departments in their mutual mission to promote and… more
- US Bank (Los Angeles, CA)
- …Legal Regulatory Group, the Law Division, Risk Management and Compliance , Audit, Finance, and Government Relations when providing legal subject matter coverage ... positions. + Provide legal support and guidance on enterprise-wide regulatory reporting and compliance projects. + Review...may vary based on role, location or hours): + Healthcare (medical, dental, vision) + Basic term and optional… more
- Caldera Medical (Westlake Village, CA)
- …and compliance . * Serve as primary liaison with global regulatory authorities, including FDA, EU Notified Bodies, NMPA, and TGA, managing communications ... Director of Regulatory Affairs ONSITE in Westlake Village, CA Caldera...manage submissions, obtain necessary licenses and approvals, and ensure compliance with US and international regulations including FDA, EU… more