Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Regulatory Affairs Specialist

ConsultNet Technology Services and Solutions

ConsultNet Technology Services and Solutions is hiring a Jr. Regulatory Affairs Specialist in Irvine, CA to support product development teams with regulatory inputs, strategies, and design controls. You will prepare QA/regulatory reports and present status in review meetings, and contribute to regulatory submissions for agencies and customers. The role requires knowledge of 21 CFR QSR/cGMPs, ISO 13485, and experience with medical device regulations. #J-18808-Ljbffr

Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Regulatory Affairs Specialist in Irvine, CA vacancy
  •  ...medical technology or similar. 5+ years of experience in Reg Affairs, QA, R&D, Manufacturing, and/or Project Management within the...  ...verbal and written communication skills. Thorough knowledge of policies, practices and procedures related to Regulatory Affairs.
    Suggested

    Katalyst Healthcares & Life Sciences

    Irvine, CA
    2 days ago
  •  ...The Kardion Regulatory Affairs team is seeking a high energy, driven individual who is looking for the unique opportunity and challenge provided...  ...team fit are paramount. The Principal Regulatory Affairs Specialist is a senior technical expert and strategic problem solver... 
    Suggested
    Full time
    Contract work
    Remote work
    3 days per week

    Kardion

    Irvine, CA
    2 days ago
  •  ...Regulatory Affairs Specialist This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including... 
    Suggested
    Work at office

    Katalyst HealthCares & Life Sciences

    Irvine, CA
    1 day ago
  •  ...Immediate hire for a Jr. Regulatory Affairs Specialist that will support product development teams to deliver regulatory inputs, strategies, reports and other design control deliverables. Prepare Quality Assurance/Regulatory reports and present status in review meetings... 
    Suggested
    Immediate start

    ConsultNet Technology Services and Solutions

    Irvine, CA
    3 days ago
  • $85k - $130k

    Job SummarySr Regulatory Affairs Specialist is an accomplished regulatory professional with a successful work history with leading regulatory initiatives and partnering with Sales and Marketing teams in obtaining domestic and internal regulatory clearances for Masimo products... 
    Suggested
    Work experience placement
    Local area
    Worldwide
    Flexible hours

    Masimo

    Irvine, CA
    2 days ago
  • $92k - $138k

     ...and other neurovascular conditions. The team partners across regulatory, quality, engineering, clinical, and commercial functions to...  .... Travel is expected to be minimal.The Senior Regulatory Affairs Specialist supports regulatory compliance and product lifecycle management... 
    Full time
    H1b
    Work at office
    Local area
    Immediate start
    Flexible hours

    Medtronic

    Irvine, CA
    5 days ago
  • Job-ID31853494Reference26-00237 Responsibilities: Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices. Assess... 

    Katalyst Healthcares & Life Sciences

    Irvine, CA
    2 days ago
  • Regulatory Affairs Specialist Responsibilities Regulatory Affairs is responsible for planning, coordinating and implementing regulatory submissions for products that require government approval. Demonstrates working knowledge of healthcare-related regulations. Demonstrates... 
    Contract work

    Indotronix Avani Group

    Irvine, CA
    5 days ago
  • Prismatik Dentalcraft is a division of Glidewell Dental. We are seeking an experienced Regulatory Affairs Specialist to support global regulatory compliance and drive high‑impact submissions. In this role, you’ll lead FDA 510(k)/PMA filings, maintain international registrations... 

    PRISMATIK DENTALCRAFT, INC.

    Irvine, CA
    3 days ago
  •  ...Regulatory Affairs Specialist (FDA, DEA) The Regulatory Affairs Specialist (FDA, DEA) will ensure BaRupOn's pharmacy, manufacturing, and healthcare operations meet all applicable regulatory requirements. This position is responsible for preparing submissions, maintaining... 

    Barupon LLC

    Irvine, CA
    3 days ago
  • $95.8k - $159.6k

     ...Senior International Regulatory Affairs Specialist Irvine, CA Join a team focused on bringing medical technologies to market while ensuring compliance with global regulatory requirements. In this role, you will support regulatory strategy, submissions, and product lifecycle... 
    Temporary work
    Local area
    Flexible hours

    Stryker

    Irvine, CA
    2 days ago
  •  ...Job Title: Senior Specialist, Regulatory Affairs Role Level: Individual Contributor Supervisor/Manager Title: Senior Manager, Regulatory Affairs Job Location & Environment: Irvine, CA – Corporate Office Environment Job Description Summary: Responsible for global regulatory... 
    Work at office

    JenaValve Technology, Inc.

    Irvine, CA
    2 days ago
  •  ...Senior Regulatory Affairs Specialist Work mode: Hybrid Onsite Location(s): Marlborough, MA, US, 01752 Additional Location(s): US-CA-Irvine; US-MN-Arden Hills; US-MN-Maple Grove Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance... 
    Work at office
    Local area
    Relocation
    3 days per week

    Boston Scientific

    Irvine, CA
    2 days ago
  • Jenavalve Technology is hiring a Senior Specialist for Regulatory Affairs in Irvine, CA with a strong focus on managing regulatory communication and submissions. The role requires substantial experience in medical device regulations, ensuring compliance with quality standards... 

    Jenavalve Technology

    Irvine, CA
    3 days ago
  •  ...registrations and submissions (510(k), PMA) to FDA and other regulatory bodies. Maintains company registrations and device listings in...  ...preferred Minimum five (5) years of experience in Regulatory Affairs. Experience in preparing (writing) domestic and international... 

    PRISMATIK DENTALCRAFT, INC.

    Irvine, CA
    1 day ago
  •  ...cardiovascular and interventional space. As the company continues to expand its global footprint, they are seeking a Senior Regulatory Affairs Specialist to support regulatory strategy, submissions, and global compliance activities across the product lifecycle. This is an... 

    EPM Scientific

    Irvine, CA
    5 days ago
  • Company DescriptionAt the dawn of the new millennium, a unique information technology company was born: HCL Technologies. As narrated in the video below, HCL Technologies has demonstrated remarkable growth through the recent economic downturn, emerging as one of only eight...

    Artech

    Irvine, CA
    2 days ago
  • $110.1k - $183.4k

    Irvine, CA In this International Regulatory Affairs role, you will ensure global product registrations move efficiently and compliantly through diverse regulatory pathways. This is a meaningful opportunity to drive operational excellence, collaborate across global teams... 
    Temporary work
    Local area
    Flexible hours

    Stryker

    Irvine, CA
    2 days ago
  •  ...Embla Medical, a part of Össur, seeks a Compliance Specialist to support the Director of Compliance in managing the Americas compliance program across state and federal regulations and company code of conduct. Responsibilities include auditing, monitoring, training coordination... 

    Össur

    Irvine, CA
    2 days ago
  •  ...Westcliff University is seeking a Regulatory Specialist to manage regulatory compliance, accreditation, licensure, and related reporting across the university and affiliated institutions. You will coordinate documentation, ensure timely submissions, and work with academic... 

    Westcliff University

    Irvine, CA
    2 days ago
  • $90k - $140k

     ...Regulatory Strategy Lead Execute on regulatory strategy of De Novo submissions for AI/ML-based Software as a Medical Device (SaMD) product, including AidaBreast. Serve as regulatory lead for novel oncology diagnostic technologies integrating genomic and proteomic... 

    PreludeDx

    Laguna Hills, CA
    1 day ago
  • $80k - $95k

     ...Regulatory Affairs SpecialistThe Regulatory Affairs Specialist is responsible for coordinating and executing routine regulatory activities that support the company's worldwide medical device business. This position supports product registrations, regulatory submissions... 
    Work at office
    Worldwide
    Weekend work
    Afternoon shift

    NIHON KOHDEN OrangeMed

    Santa Ana, CA
    3 days ago
  • $99.4k - $124.3k

     ...Compliance Specialist (Regulatory Change & Governance)Shaping the Future of LendingWith 30 years of fintech leadership, Origence empowers credit...  ..., risk management, project management, regulatory affairs, operations, financial services, fintech, SaaS, lending, or... 
    Full time
    Local area

    Origence

    Irvine, CA
    3 days ago
  •  ...Kura Sushi USA in Irvine, CA is seeking a GRC Senior Regulatory Compliance Analyst to join our hybrid team. You will assist the Integrated GRC Senior Manager to ensure Kura meets legal, regulatory and internal standards across operations, contracts and vendor engagements... 

    Kura Sushi Corporate Support Center

    Irvine, CA
    4 days ago
  • $84k - $85k

     ...and attend affordable and LIHTC audits performed by state and regulatory agencies. Review applications and determine eligibility for the...  ...of Affordable Multi‑Housing experience. Certified Occupancy Specialist or similar certifications are required. 2 years’ experience in... 
    Contract work
    Local area
    Immediate start

    Avanath Realty

    Irvine, CA
    3 days ago
  •  ...assist in the implementation and maintenance of the bank's compliance program. You will be responsible for monitoring and analyzing regulatory requirements, internal policies, and industry standards to ensure the bank operates in adherence to applicable laws and... 
    Work at office

    CommerceWest Bank

    Irvine, CA
    5 days ago
  •  ...support Prepare on demand reports and SKU lists for Compliance Specialists and Management Review and upload approved classification data...  ...determined by Supervisor Administrative support for required regulatory reporting requirements in a timely manner. Export Control... 
    Immediate start
    Flexible hours

    Ingram Micro

    Irvine, CA
    3 days ago
  • $61.12k - $95.39k

     ...& Supports solutions. Helping people live a Life Without Limitations is why we exist as a company. About the Role The Compliance Specialist is responsible for assisting the Director of Compliance in the management of the compliance program for Embla Medical’s Americas... 
    Full time
    Work experience placement
    Local area
    Worldwide

    Össur

    Irvine, CA
    2 days ago
  • $25 per hour

     ...opportunities.We are seeking an experienced Labor Compliance Specialist to join our team. The ideal candidate will have 3–5 years of California...  ...and maintain labor compliance documentation, reports, and regulatory filings.Ensure compliance with contractual obligations,... 
    Hourly pay
    Contract work
    Apprenticeship
    For subcontractor
    Work at office
    Local area

    Ohla

    Irvine, CA
    3 days ago
  • $70k - $90k

     ...Compliance Specialist CopperPoint has an exciting opportunity for a Compliance Specialist. In this role, you'll help develop and administer an effective regulatory compliance program that ensures adherence to state regulatory and statutory requirements. You'll research... 
    Hourly pay
    Temporary work
    Flexible hours

    CopperPoint Insurance Companies

    Irvine, CA
    2 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Regulatory Affairs Specialist. Be the first to apply!