Director Regulatory - San Jose, CA

+ Lead U.S. FDA submissions including 510(k), De Novo, PMA, Q-Sub meetings, responses, amendments, · and technical documentation. · + Develop and execute regulatory strategies for digital pathology products, · imaging devices, · and AI/ML-based medical software.,+ Ensure complian ...

OptraSCAN is committed to transforming pathology through its innovative AI-powered digital pathology solutions. · ...

+Job Summary · Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that ...

This is a full-time Director of Global Regulatory Affairs role based in San Jose, CA. The candidate will develop and implement regulatory strategies for global compliance. · ...

We are searching for the best talent for a Director, This role will be based in Santa Clara, CA and will work a Flex/Hybrid schedule. Relocation assistance may be available on a case-by-case basis. · Develop global regulatory strategies to gain earliest possible, least burdensome ...

We are searching for the best talent for a Director, Regulatory Affairs to support our Monarch robotics platform. · ...

+Job Summary · Noah Medical is building the future of medical robotics. · We are looking for exceptional engineers and key team members. · The Director of RA/QA reports to the Head of Quality and Regulatory.About YouRequires a BS (preferably in Engineering or Technology) with a f ...

Noah Medical is building the future of medical robotics. · Noah Medical seeks a highly motivated and experienced Quality Assurance (QA) and Regulatory Affairs (RA) professional to lead our RA/QA function. ...

We are seeking a Director of Regulatory Affairs to join our team at Revolution Medicines. · ...

The Director of Quality and Regulatory Affairs will join a rapidly growing medical device startup at a pivotal stage of development and commercialization. · This role will serve as a senior leader responsible for building, scaling, and owning the company's quality and regulatory ...

We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients. At Septerna we strive to embrace diversity of thought, expertise and background through collaboration. · ...

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless ...

This innovative patient-focused commercial-stage biopharmaceutical company is seeking a Regulatory Affairs Director to lead the development and implementation of regulatory strategy for a key oncology asset. The company offers flexible work arrangements competitive compensation s ...

We are seeking a Director of Regulatory Affairs for Companion Diagnostics (CDx) to define and lead the end-to-end global regulatory diagnostic strategy for our portfolio. · The Global Head of Regulatory Affairs for CDx will ensure synchronized drug–diagnostic co-development from ...

Proclinical is seeking a Senior Director, Regulatory Affairs for a growing and exciting clinical-stage biotechnology company based in the San Francisco Bay Area. · ...

As a pioneer and market leader in robotic-assisted surgery we strive to foster an inclusive and diverse team committed to making a difference. · ...

The Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs. · ...

The Associate Director, Regulatory Operations will serve as a key publishing lead within the Regulatory Operations function, · responsible for managing and executing regulatory submission activities to support the company's growing pipeline and portfolio. · ...

+Job summary · The Associate Director of Regulatory Affairs will independently represent regulatory affairs on cross-functional teams and provide targeted, actionable advice across the clinical development organization. · +Demonstrate leadership within the regulatory affairs depa ...

The Director of Regulatory Operations will lead and be accountable for global regulatory submissions execution, submission-related policies, and end-to-end regulatory processes that support growth and increased portfolio complexity. · ...