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Regulatory affairs Jobs in San francisco ca

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Regulatory affairs • san francisco ca

Last updated: 1 day ago

Regulatory Affairs Associate

ExperisAlameda, CA, United States
Full-time

We are seeking a Regulatory Affairs Associate to join one of our leading healthcare clients.We are seeking a Regulatory Affairs Associate to support the Regulatory Affairs team by reviewing labelin... Show more

Manager, Regulatory Affairs

Jade BiosciencesSan Francisco, CA, United States
$135,000.00 yearly
Full-time

Boston; Remote; San Francisco; Seattle.Jade Biosciences is a clinical-stage biotechnology company focused on developing best-in-class therapies that address critical unmet needs in autoimmune disea... Show more

Director, Regulatory Affairs

CytokineticsSouth San Francisco, CA, United States
$225,000.00 yearly
Full-time

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new... Show more

Senior Director/ Director, CMC Regulatory Affairs

ORIC Pharmaceuticals Inc.South San Francisco, CA, United States
$250,000.00 yearly
Full-time

Senior Director/ Director, CMC Regulatory Affairs.Reporting to the Chief Technical Officer, we are currently hiring a Director, CMC Regulatory Affairs, to join our Technical Operations team.This po... Show more

Senior Manager Regulatory Affairs (contract)

AlumisSouth San Francisco, CA, United States
$165,000.00 yearly
Full-time

Senior Manager Regulatory Affairs (contract).Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally cha... Show more

Head of Regulatory Affairs

Remedy RoboticsSan Francisco, CA, United States
Full-time

Remedy Robotics is a medical technology company developing robotic systems for endovascular intervention.Its proprietary technology combines robotics, machine learning, and advanced computer vision... Show more

Sr. Director, Regulatory Affairs - CMC

BridgeBio PharmaSan Francisco, CA, United States
Full-time

Director, Regulatory Affairs - CMC.When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement.In 2015, we pion... Show more

Director, CMC Regulatory Affairs

Vir BiotechnologySan Francisco, CA, United States
$195,500.00 yearly
Full-time

Director, CMC Regulatory Affairs.Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN dual-masked T-cell engagers across validated targets in solid tumor... Show more

Manager, Regulatory and Market Affairs

Pattern Energy GroupSan Francisco, CA, United States
$103,000.00 yearly
Full-time

Regulatory Affairs And Market Analysis And Strategy.Pattern Energy is a leading renewable energy company that develops, constructs, owns, and operates high-quality wind and solar generation, transm... Show more

Director/Senior Director, Regulatory Affairs

SepternaSouth San Francisco, CA, United States
$235,000.00 yearly
Full-time

Director/Senior Director, Regulatory Affairs.Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to bec... Show more

Staff Regulatory Affairs Engineer

Hinge HealthSan Francisco, CA, United States
Full-time

Staff Regulatory Affairs Engineer.The Staff Regulatory Affairs Engineer is the primary regulatory strategist and architect for our AI/ML Software as a Medical Device (SaMD) portfolio.While many com... Show more

Head of Regulatory Affairs

BlackbirdSan Francisco, CA, United States
Full-time

Remedy Robotics is a medical technology company developing robotic systems for endovascular intervention.Its proprietary technology combines robotics, machine learning, and advanced computer vision... Show more

Regulatory Affairs Strategy Manager (Oncology)

ExelixisAlameda, CA, United States
$124,500.00 yearly
Full-time

Responsible for managing and maintaining existing Investigational New Drug (IND), Clinical Trial Application (CTA), New Drug Application (NDA), and Biologics Licensing Application (BLA) submissions... Show more

Director, Regulatory Affairs

NurixBrisbane, CA, United States
Full-time

Position Title: Director, Regulatory Affairs (Strategy, Immunology and Inflammation).Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and comm... Show more

Director, Regulatory Affairs

Enigma SearchSouth San Francisco, CA, United States
Full-time

South San Francisco, California, United States.Are you a seasoned Regulatory Affairs professional ready to make a significant impact on human health? We are seeking a strategic and driven Director ... Show more

(Senior) Manager, Regulatory Affairs

Braveheart BioSan Francisco, CA, United States
$119,000.00 yearly
Full-time

Senior) Manager, Regulatory Affairs.San Francisco, CA or Remote or Hybrid.Braveheart Bio is a clinical-stage biopharmaceutical company focused on developing therapies for patients with hypertrophic... Show more

Director of Regulatory Affairs and Policy

SupplyBank.orgOakland, CA, US
Full-time

Job Description: Director of Regulatory Affairs and Policy SupplyBank.Director of Regulatory Affairs and Policy to help advance one of the most ambitious community-serving development and policy in... Show more

Associate Director, Regulatory Affairs (on-site)

AbbottAlameda, CA, United States
$148,700.00 yearly
Full-time

Associate Director Regulatory Affairs.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 ... Show more

Senior Director, Regulatory Affairs

Annexon BiosciencesSan Francisco, CA, United States
$216,000.00 yearly
Full-time

Senior Director, Regulatory Affairs.At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classica... Show more

Director, Regulatory Affairs Advertising & Promotion

Acadia PharmaceuticalsSan Francisco, CA, United States
$193,400.00 yearly
Full-time

Please note that this position can be based in San Diego, CA; Princeton, NJ; San Francisco, CA.Acadia's hybrid model requires this role to work in our office an average of 3 days per week.Responsib... Show more

Regulatory Affairs Associate

Regulatory Affairs Associate

ExperisAlameda, CA, United States
13 days ago
Job type
  • Full-time
Job description

Regulatory Affairs Associate

We are seeking a Regulatory Affairs Associate to join one of our leading healthcare clients.

Position Overview

We are seeking a Regulatory Affairs Associate to support the Regulatory Affairs team by reviewing labeling, advertising, and promotional materials, ensuring regulatory compliance, supporting regulatory submissions, and collaborating with cross-functional teams. This role also supports new product introductions (NPI) and post-market regulatory activities.

Key Responsibilities

  • Review labeling, advertising, and promotional materials for regulatory compliance.
  • Partner with Marketing to provide regulatory guidance and approval support.
  • Support regulatory submissions, including 510(k), PMA, Health Canada, and Latin America submissions.
  • Assist with NPI and post-market regulatory activities.
  • Develop and review Regulatory Affairs SOPs.
  • Communicate regulatory requirements to cross-functional teams.
  • Prepare and maintain regulatory documentation.

Required Qualifications

  • Bachelor's degree or equivalent experience.
  • Minimum 2 years of experience in a regulated industry (Medical Device, Pharmaceutical, Nutrition, or Food).
  • Regulatory Affairs experience preferred; Quality, R&D, Scientific Affairs, or Operations experience will also be considered.
  • Strong written and verbal communication skills.
  • Excellent analytical, project management, and organizational skills.
  • Strong attention to detail and ability to work collaboratively.

Preferred Qualifications

  • Bachelor's degree in a scientific, engineering, medical, or Regulatory Affairs discipline.
  • 1+ year of Regulatory Affairs or Quality experience within the Medical Device industry.
  • Experience reviewing labeling, advertising, or promotional materials.
  • Knowledge of FDA regulations, Medical Device Quality Systems, Design Controls, and international regulatory requirements.
  • RAC certification is a plus.
  • Proficiency with Microsoft Word, Excel, PowerPoint, Visio, and SharePoint.