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Regulatory affairs Jobs in Irvine, CA

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Regulatory affairs • irvine ca

Last updated: 20 hours ago

Regulatory Affairs Manager

Huisong PharmaceuticalsSanta Ana, California, United States
$38.00 hourly
Part-time
Quick Apply

Santa Ana, California, Orange County.Part-time, approximately 10 hours per week.Santa Ana, California, is the U.Founded in 1998, Huisong Pharmaceuticals specializes in the research, development, an... Show more

Coord 3, Regulatory Affairs

Kaygen Inc.Irvine, CA, US
Full-time +1

KAYGEN is an emerging leader in providing top talent for technology-based staffing services.We specialize in providing high-volume contingent staffing, direct hire staffing and project-based soluti... Show more

Regulatory Affairs Manager I

AlconFoothill Ranch, CA, United States
$130,900.00 yearly
Full-time

At Alcon, we're passionate about enhancing sight and helping people see brilliantly.With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye... Show more

Principle Regulatory Affairs Strategy Associate

ArtechFoothill Ranch, CA, United States
Full-time

Principle Regulatory Affairs Strategy Associate.The Principle Regulatory Affairs Strategy Associate, reporting to the Senior Director of Regulatory Affairs (LLSI), is primarily responsible for sett... Show more

Regulatory Affairs Manager

Katalyst Healthcares & Life SciencesIrvine, CA, United States
Full-time

In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulat... Show more

Junior Regulatory Affairs Specialist

Pro-Dex, Inc.Irvine, CA, United States
Full-time

Regulatory And Compliance Specialist.Supports tasks related to Regulatory and Compliance activities including tasks to ensure compliance during product development activities, local, state, federal... Show more

Regulatory Affairs Specialist V

eTeamFoothill Ranch, CA, United States
Full-time

Regulatory Affairs Specialist V.The role involves setting or executing regulatory strategy, leading and managing as a strategist, ensuring local product registration, facilitating health registrati... Show more

VP of Quality & Regulatory Affairs

SiegfriedIrvine, CA, United States
$215,000.00 yearly
Full-time

Vice President of Quality Assurance.Expect to grow, personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents.As a trusted and respe... Show more

Regulatory Affairs Manager

HuisongSanta Ana, CA, United States
Part-time

Regulatory Affairs Manager to support regulatory strategy and compliance for dietary supplements, botanical ingredients, herbal extracts, and Traditional Chinese Medicine products.The Regulatory Af... Show more

Specialist, Regulatory Affairs Surgical

Edwards LifesciencesIrvine, CA, United States
$74,000.00 yearly
Full-time

Make a meaningful difference to patients around the world.From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international r... Show more

Coord 3, Regulatory Affairs

KaygenIrvine, CA, United States
Full-time +1

Regulatory Affairs Coordinator 3 (Contract).KAYGEN is an emerging leader in providing top talent for technology-based staffing services.We specialize in providing high-volume contingent staffing, d... Show more

Manager, Regulatory Affairs (International)

JenaValve Technology, Inc.Irvine, CA, United States
Full-time

Manager, Regulatory Affairs (International).Irvine, CA Corporate Office Environment.Manages global regulatory affairs communication, filing strategy, submission development, regulatory negotiation... Show more

Regulatory Affairs Specialist II

Bio-Rad Laboratories, Inc.Irvine, California, United States
$86,000.00 yearly
Full-time

Regulatory Affairs Specialist II.In this position you will support new product developments/product modifications, IVDR implementation, and international product registrations.This position must be... Show more

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Regulatory Affairs Coordinator

MindlanceIrvine, California, United States
Full-time
Quick Apply

Regulatory Affairs Coordinator.The Regulatory Affairs Coordinator III independently supports and executes regulatory activities for U.Class II and EU Class II & Class III medical devices across... Show more

Manager II, Regulatory Affairs

TarsanetIrvine, CA, United States
$120,000.00 yearly
Full-time

Manager II, Regulatory Affairs.Irvine, California, United States.The Manager II, Regulatory Affairs will report to the Sr.Director, Regulatory Affairs, and will manage the labeling, advertising, an... Show more

Coord 3, Regulatory Affairs

Pyramid ConsultingIrvine, CA, United States
Temporary

Immediate need for a talented Coord 3, Regulatory Affairs.This is a 12 months contract opportunity with long-term potential and is located in Irvine, CA (Onsite).Please review the job description b... Show more

Principle Regulatory Affairs Strategy Associate

Sunrise SystemsFoothill Ranch, CA, United States
$79.71 hourly
Full-time

Principle Regulatory Affairs Strategy Associate.The Principle Regulatory Affairs Strategy Associate, reporting to the Senior Director of Regulatory Affairs (LLSI), is primarily responsible for sett... Show more

Regulatory Affairs Specialist, Sr.

GlidewellIrvine, CA, United States
$84,716.01 yearly
Full-time

Prismatik is seeking an experienced Sr.Regulatory Affairs Specialist to support global regulatory compliance and drive high-impact submissions.In this role, you'll lead FDA 510(k)/PMA filings, main... Show more

Coord 3, Regulatory Affairs

MillenniumSoft IncIrvine, CA, United States
$90.00 hourly
Full-time
Quick Apply

MAX Bill rate:</b> $90/hr<br><b>Work schedule: </b>M-F 8am - 5pm<br>Hybrid-2 days per week on site.Job Title:</b> Regulatory Affairs Coordinator 3 (Contract) &... Show more

Regulatory Affairs Specialist (FDA, DEA )

BaRupOn LLCIrvine, California, United States
Full-time

Regulatory Affairs Specialist (FDA, DEA).BaRupOn's pharmacy, manufacturing, and healthcare operations meet all applicable regulatory requirements.This position is responsible for preparing submissi... Show more

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Regulatory Affairs Manager

Regulatory Affairs Manager

Huisong PharmaceuticalsSanta Ana, California, United States
4 days ago
Salary
$38.00 hourly
Job type
  • Part-time
  • Quick Apply
Job description
Regulatory Affairs ManagerCompany: Huisong Inc.
Location: Santa Ana, California, Orange County
Schedule: Part-time, approximately 10 hours per week
Work Arrangement: On-site

About Huisong Inc.Huisong Inc., located in Santa Ana, California, is the U.S. office of Huisong Pharmaceuticals. Founded in 1998, Huisong Pharmaceuticals specializes in the research, development, and manufacturing of premium-quality natural ingredients for leading companies in the pharmaceutical, nutraceutical, food and beverage, and personal care industries. Today, Huisong Pharmaceuticals operates globally and offers an extensive portfolio of natural products and ingredients. Guided by its core values of Nature, Health, and Science, Huisong continues to advance medicine and nutrition in support of health and well-being worldwide.

Official Company Website: https://www.huisongpharm.com/

Position OverviewHuisong Inc. is seeking an experienced Regulatory Affairs Manager to support regulatory strategy and compliance for dietary supplements, botanical ingredients, herbal extracts, and Traditional Chinese Medicine products.

The Regulatory Affairs Manager will support the U.S. business while collaborating with Huisong’s corporate office, global teams, suppliers, and business partners.

Key Responsibilities:
  • Develop and implement regulatory strategies for new and existing products, including dietary supplements, herbal extracts, botanical ingredients, and Traditional Chinese Medicine products.
  • Lead or support FDA submissions and regulatory pathways, including New Dietary Ingredient Notifications, GRAS determinations, and applicable OTC monograph requirements.
  • Support international product registrations, including EU Novel Food applications and Health Canada Natural Health Product registrations.
  • Advise senior management on new and emerging regulations, including FDA updates, California Proposition 65, FSMA, and international regulatory developments.
  • Ensure compliance with applicable current Good Manufacturing Practices, including 21 CFR Parts 111 and 117, ISO 9001 standards, and USDA and EU organic certification requirements.
  • Manage FDA, NSF, customer, and third-party regulatory audits and oversee corrective and preventive actions.
  • Review product labels, marketing materials, and product claims for compliance with FDA and FTC requirements, including structure/function claims and Traditional Chinese Medicine disclosures.
  • Collaborate with Research and Development, Sales, Quality, and Supply Chain teams to align regulatory requirements with business goals.
  • Work with global suppliers to ensure raw material compliance, including ingredient identity, adulteration testing, heavy metal limits, pesticide limits, and supporting documentation.
  • Navigate regulations and standards specific to botanicals and Traditional Chinese Medicine, including the USP Herbal Medicines Compendium, World Health Organization guidance, and China NMPA standards.
  • Address regulatory matters involving botanical adulteration, safety data, ingredient identity, and traditional-use claims.

Education and Experience Requirements:
  • Bachelor’s degree or equivalent education in pharmacy, chemistry, food science, herbal medicine, regulatory affairs, or a related scientific field.
  • At least five years of regulatory affairs experience within the nutraceutical, dietary supplement, botanical, herbal medicine, or Traditional Chinese Medicine industries.
  • Strong working knowledge of:
    • FDA 21 CFR Parts 111 and 117
    • Dietary Supplement Health and Education Act
    • New Dietary Ingredient Notifications
    • GRAS requirements
    • Current Good Manufacturing Practices
    • ISO 9001
    • Foreign Supplier Verification Programs
    • U.S. and international dietary supplement regulations
  • Preventive Controls Qualified Individual certification is required.
  • HACCP certification or related food-safety training is preferred.
  • Regulatory Affairs Certification is a plus.

Additional Qualifications:
  • Experience managing FDA, customer, or third-party certification audits.
  • Experience working with international suppliers and corporate teams.
  • Strong analytical, communication, organizational, and documentation skills.
  • Ability to interpret complex regulatory requirements and provide practical guidance to leadership and cross-functional teams.
  • Ability to work independently and manage priorities within a part-time schedule.