Senior Regulatory Affairs Lead, Gene Therapy

Intuitive Surgical, Inc. in Sunnyvale, CA, is seeking a Sr. Manager, Regulatory Affairs for the Digital Portfolio to lead regulatory strategy and execution for SaMD/SiMD, cloud and AI-enabled features that support surgical care. You will build and guide a regulatory team across Digital, R&D, Quality, Cybersecurity, Privacy, Legal, and Commercial partners....

WHO WE ARE** :** At Dendreon,we’retransforming the battle against cancer with personalized immunotherapy. Our flagship product,PROVENGE® (sipuleucel-T), was the first FDA-approved immunotherapy for metastatic castrate-resistant prostate cancer,utilizinga patient’s own immune cells to fight the disease. If you’re driven by the opportunity to make a...

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for...

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable...

Dendreon Pharmaceuticals LLC in California is seeking a Manager of Regulatory Affairs (CMC) to lead regulatory strategies for biologics, cell, and gene therapies. You will drive submissions, provide strategic guidance, and coordinate with cross-functional teams to ensure compliance and timely regulatory outcomes.The role requires on-site presence at Seal...

Select how often (in days) to receive an alert: At Sonova, we envision a world where everyone can enjoy the delight of hearing. This vision inspires us and fuels our commitment to developing innovative solutions that improve hearing health and human connection - from personal audio devices and wireless communication systems to hearing aids and cochlear...

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process. Senior Regulatory Affairs Specialist FullTime San Mateo, CA, US Salary Range: $140,000.00 To $160,000.00 Annually About Route 92 Medical Route 92 Medical is on a mission to improve outcomes for patients...

I'm hiring a Principal Regulatory Affairs Specialist for an innovative, publicly traded medical device company developing next-generation technologies for minimally invasive procedures.With an expanding product portfolio and several critical regulatory milestones approaching, this is a high-impact opportunity to take ownership of global regulatory...

Viltis is seeking an experienced Senior Regulatory Affairs Specialist to support a leading medical device organization in Alameda, CA. The role focuses on regulatory change assessments and U.S. medical device submissions, ensuring compliance across product lifecycle. The ideal candidate brings 7+ years of regulatory affairs experience and will partner with...