Regulatory affairs • santa clara ca
AI-driven healthcare projects by reviewing and evaluating regulatory documentation.The role involves assessing clinical documents, ensuring compliance with regulatory guidelines, identifying incons... Show more
Regulatory submissions including Original ANDAs, Amendments, Annual Reports, Supplements and PADERs to company applications.Preparation/Review of Original submission/Amendments/ Supplements as assi... Show more
Manager, Regulatory Affairs, Regulatory PMO.Manager, Regulatory Affairs, Regulatory PMO.Minimum qualifications: Bachelor's degree or equivalent practical experience.Experience in people management ... Show more
Develops and implements programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with national/regional/global regulations.Regu... Show more
Director, Regulatory Affairs (FDA).Location: Allendale, NJ - 07401 Duration: Full time Salary Range: $171,000 - $190,000 + 15% year-end bonus Client: Hitachi Chemicals Visa requirement: Only US cit... Show more
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.We’re a team of engineers, clin... Show more
Sr Regulatory Affairs Specialist, Global Market Protection.M-F, standard working hours .The Regulatory Affairs Senior Specialist is responsible for serving as the RA lead on product lifecycle ... Show more
Established medical device company is looking to hire a Sr.Regulatory Affairs Specialist to join their growing team! Must bring a BS degree and a minimum of 8 years of regulatory affairs experience... Show more
Senior Regulatory Affairs Specialist.Primary Function of Position This role provides expert support for regulatory project management, strategic submissions, and cross-functional compliance activit... Show more
Associate Director, Regulatory Affairs.Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatmen... Show more
Take your regulatory affairs experience to the next level with an exciting opportunity supporting innovative in vitro diagnostic (IVD) products.This role offers hands-on involvement with global reg... Show more
Location: Sunnyvale, CA - Hybrid.Duration: 06 Months Onsite: Onsite 3 Days Per Week.Primary Function of Position: The Sr.Regulatory Affairs primary responsibilities include developing regulatory pl... Show more
This Regulatory Affairs Manager position is an onsite opportunity.The candidate will combine knowledge of scientific, regulatory, and business issues to enable products, including combination produ... Show more
We are searching for an experienced regulatory professional to work within the Companion Diagnostics (CDx) team of Dako North America.Director, Regulatory Affairs (CDx), the successful candidate mu... Show more
Senior Regulatory Affairs Specialist.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 h... Show more
AngioSafe is a Bay Area company focusing on improving healthcare delivery through state-of-the-art catheter development.We are pioneering the development of novel treatment mechanisms and algorithm... Show more
International Regulatory Affairs Lead (Medical Devices).The Health group is looking for an International Regulatory Affairs Lead to head a team responsible for international expansion of Apple Heal... Show more
At Johnson & Johnson,we believe health is everything.Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are ... Show more
Principal Regulatory Affairs Specialist.Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company.We are committed to revolu... Show more
Our client, a leading organization in the medical device industry, is seeking a Regulatory Specialist to join their team.As a Regulatory Specialist, you will be part of the Regulatory Affairs Opera... Show more
The average salary range is between $ 74,006 and $ 170,765 year , with the average salary hovering around $ 105,135 year .
We are seeking an experienced Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing and evaluating regulatory documentation. The role involves assessing clinical documents, ensuring compliance with regulatory guidelines, identifying inconsistencies, and providing clear, evidence-based feedback to improve AI-generated regulatory content.
Review and evaluate clinical and regulatory documentation.
Assess regulatory submissions and responses for accuracy and compliance.
Ensure adherence to ICH guidelines and CTD/eCTD requirements.
Identify regulatory risks, inconsistencies, and unsupported claims.
Prepare structured, guideline-based written feedback.
5+ years of Regulatory Affairs experience in the pharmaceutical, biotech, or CRO industry.
Experience with clinical submissions, regulatory documentation, and health authority interactions.
Strong knowledge of ICH guidelines and CTD/eCTD structure.
Excellent analytical, critical thinking, and written communication skills.
Degree in Life Sciences, Pharmacy, Medicine, or a related field.
