Current jobs related to Regulatory Affairs Consultant - Irvine - ALKU

  • Regulatory Affairs Senior Consultant, Critical Care

    4 weeks ago

    Irvine, California, United States Orange County Regulatory Affairs Discussion Group (OCRA) Full time

    Regulatory Affairs Senior Consultant, Critical CareCompany: Orange County Regulatory Affairs Discussion Group (OCRA)Position: Senior Regulatory Affairs SpecialistLocation: Remote/HybridOverview: Join a team dedicated to enhancing patient outcomes through innovative regulatory strategies. As a Senior Consultant in Regulatory Affairs, you will play a pivotal...

  • Lead Specialist in Regulatory Affairs for Critical Care

    4 weeks ago

    Irvine, California, United States Regulatory Affairs Professionals Society Full time

    Join Our Team:At Regulatory Affairs Professionals Society, we are dedicated to advancing the field of regulatory affairs, particularly within the Critical Care sector. Our mission is to ensure that every patient receives the highest standard of care through innovative medical technologies.Your Role:As a Senior Regulatory Affairs Specialist, you will play a...

  • Senior Regulatory Affairs Specialist, Critical Care

    4 weeks ago

    Irvine, California, United States Regulatory Affairs Professionals Society Full time

    Join Our Team as a Senior Regulatory Affairs Specialist in Critical CareFor over five decades, the Critical Care division at Regulatory Affairs Professionals Society has been at the forefront of pioneering medical advancements and enhancing patient care. Our mission is clear: we strive to ensure that every patient requiring monitoring has access to...

  • Regulatory Affairs Consultant

    4 weeks ago

    Irvine, California, United States Inari Medical Full time

    The Regulatory Affairs Specialist operates with a degree of autonomy, providing support to interdisciplinary teams in the formulation and implementation of regulatory strategies for innovative devices and modifications.Key Responsibilities Act as the regulatory liaison for cross-functional project teams.Develop and implement regulatory strategies for new...

  • Regulatory Affairs Consultant

    4 weeks ago

    Irvine, California, United States Jobot Full time

    Join a reputable medical device organization as a Regulatory Affairs SpecialistThis opportunity is hosted by Jobot.Compensation: $80,000 - $95,000 annuallyAbout Us:We are a leading manufacturer in the medical device sector, seeking a Regulatory Affairs Specialist to enhance our team. Candidates with experience in Class II/III medical devices are encouraged...

  • Lead Regulatory Affairs Consultant

    4 weeks ago

    Irvine, California, United States myTOD, LLC Full time

    Senior Compliance Specialist in Regulatory AffairsAbout myTOD, LLC:myTOD, LLC is at the forefront of Smart Technology, committed to revolutionizing the medical device sector with pioneering solutions that improve patient outcomes. Our advanced products are crafted to adhere to the highest standards of quality and regulatory adherence. As an expanding...

  • Lead Regulatory Affairs Consultant

    4 weeks ago

    Irvine, California, United States NeuroVasc Technologies, Inc. Full time

    Company Overview:NeuroVasc Technologies, Inc. is committed to delivering excellence through innovation and integrity in the medical device sector.Position Summary:The Senior Regulatory Affairs Specialist will report directly to the CEO and will be tasked with orchestrating global product registrations and spearheading regulatory submission strategies. This...

  • Regulatory Affairs Specialist

    2 days ago

    Irvine, California, United States Actalent Full time

    Job Title:Sr Regulatory Affairs SpecJob Description:As a Sr Regulatory Affairs Spec at Actalent, you will play a critical role in ensuring the company's products meet regulatory requirements. Your responsibilities will include coordinating and preparing document packages for regulatory submissions, leading the compilation of materials required for...

  • Director of Regulatory Affairs

    3 days ago

    Irvine, United States Diality Full time

    Company & Job Overview:Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis...

  • Director of Regulatory Affairs

    4 days ago

    Irvine, United States Diality Full time

    Company & Job Overview:Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis...

  • Regulatory Affairs Specialist

    7 days ago

    Irvine, California, United States Cypress HCM Full time

    Regulatory Affairs SpecialistThis is an exciting opportunity to contribute to the success of Cypress HCM, a leading biotech company. As a Regulatory Affairs Specialist, you will play a crucial role in supporting the transition to the In Vitro Diagnostic Regulation (IVDR) for our products.Key Responsibilities:Prioritize and monitor cases throughout the day,...

  • Regulatory Affairs Specialist

    2 weeks ago

    Irvine, California, United States Brett Fisher Group Full time

    Job DescriptionAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Brett Fisher Group. As a key member of our organization, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.Key ResponsibilitiesDevelop and implement regulatory strategies to support the...

  • Regulatory Affairs Specialist

    4 weeks ago

    Irvine, United States Elevate Search Full time

    Elevate Search is partnering with an Irvine-based medical device company developing an implantable breakthrough device for the US population to find a Regulatory Affairs Project Manager. This person will report to the Director of Regulatory Affairs.This is an extremely exciting opportunity to assist with the FDA approval of a groundbreaking device (patients...

  • Regulatory Affairs Specialist

    4 weeks ago

    Irvine, United States Elevate Search Full time

    Elevate Search is partnering with an Irvine-based medical device company developing an implantable breakthrough device for the US population to find a Regulatory Affairs Project Manager. This person will report to the Director of Regulatory Affairs.This is an extremely exciting opportunity to assist with the FDA approval of a groundbreaking device (patients...

  • Director, Regulatory Affairs

    4 weeks ago

    Irvine, United States DIALITY INC Full time $199,000 - $230,000

    Job DescriptionJob DescriptionDiality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile...

  • Regulatory Affairs Specialist

    2 weeks ago

    Irvine, California, United States Gable Search Group Full time

    {"Job Title": "Regulatory Affairs Specialist", "Job Responsibilities": "As a key member of our team, you will provide guidance on regulatory requirements and assist in regulatory-related projects and tasks to ensure compliance with FDA regulations, ISO standards, and other regulatory agencies.Key Responsibilities:Develop and implement regulatory strategic...

  • Regulatory Affairs Specialist

    6 days ago

    Irvine, California, United States Planet Pharma Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Planet Pharma. As a key member of our regulatory team, you will be responsible for ensuring compliance with global regulatory requirements for medical devices.Key ResponsibilitiesDevelop and implement regulatory strategies to ensure compliance with global...

  • Regulatory Affairs Specialist

    6 days ago

    Irvine, California, United States Cypress HCM Full time

    Job OverviewCypress HCM is seeking a highly skilled Regulatory Affairs Specialist to support our In Vitro Diagnostic Regulation (IVDR) transition activities. This is an exciting opportunity to join a leading biotech company and contribute to the success of our products.Key ResponsibilitiesPrioritize and monitor cases throughout the day, providing status...

  • Regulatory Affairs Specialist

    1 week ago

    Irvine, California, United States University Of California Irvine Full time

    About the RoleThe University of California, Irvine is seeking a highly skilled Regulatory Affairs Coordinator to join our team at the Center for Clinical Research. As a key member of our team, you will play a critical role in ensuring the successful management of the regulatory aspects of each study conducted through our center.Key ResponsibilitiesManage...

  • Regulatory Affairs Specialist

    6 days ago

    Irvine, California, United States University Of California Irvine Full time

    OverviewThe University of California, Irvine is seeking a highly skilled Regulatory Affairs Coordinator to join our team at the Center for Clinical Research. As a key member of our team, you will play a critical role in ensuring the successful management of the regulatory aspects of each study conducted through our center.ResponsibilitiesEnsure compliance...

Regulatory Affairs Consultant

3 months ago

Irvine, United States ALKU Full time

Japanese Regulatory Affairs SME

Job Summary:

We are seeking an experienced and highly knowledgeable Medical Device Regulatory Affairs Consultant with expertise in Japanese medical device regulations. The ideal candidate must be fluent in Japanese and possess in-depth knowledge of Japanese regulatory requirements (PMDA) as well as having direct experience writing authorized rep submissions. This role is critical in ensuring compliance with Japanese regulations for critical care cardiac monitoring devices, particularly those incorporating software and AI elements. The consultant will be responsible for gathering reports, reviewing protocols, and updating submissions to meet Japanese standards, while also working directly with international notified bodies and licensed representatives in the region.

Key Responsibilities:

  1. Japanese Regulatory Compliance: Serve as the subject matter expert on Japanese medical device regulations and ensure that all products and submissions comply with Japanese standards.
  2. Fluent Japanese Communication: Effectively communicate in Japanese with regulatory authorities, notified bodies, and licensed representatives to facilitate compliance and approval processes.
  3. Product Assessment: Assess critical care cardiac monitoring devices, with a strong focus on software and AI components, to ensure compliance with Japanese regulatory requirements.
  4. Documentation and Submission: Prepare, review, and update regulatory documents and submissions specific to the Japanese market, ensuring alignment with local standards.
  5. Notified Body Coordination: Collaborate with international notified bodies to address regulatory inquiries and ensure that products meet both Japanese and international standards.
  6. Licensed Representative Collaboration: Work closely with licensed representatives in Japan to navigate the local regulatory landscape and maintain compliance.
  7. Regulatory Strategy: Develop and execute regulatory strategies specific to the Japanese market, aiming for timely approvals and compliance maintenance.
  8. Regulatory Intelligence: Stay abreast of changes and updates to Japanese medical device regulations, providing proactive guidance to internal teams.
  9. Risk Management: Identify and mitigate regulatory risks associated with product development and changes, proactively addressing potential issues.
  10. Cross-Functional Collaboration: Collaborate with internal teams, including R&D, Quality Assurance, and Legal, to ensure regulatory requirements are integrated into the product development process.

Qualifications:

  • A minimum of 5 years of experience in medical device regulatory affairs, with a specific focus on Japanese regulations.
  • Fluent in Japanese, with the ability to effectively communicate and negotiate with Japanese regulatory authorities.
  • In-depth knowledge of Japanese regulatory requirements and standards for medical devices.
  • Strong familiarity with software and AI medical device regulations.
  • Proven experience in preparing and updating regulatory submissions for the Japanese market.
  • Excellent communication skills and the ability to work seamlessly within cross-functional teams.
  • Strong analytical and problem-solving abilities, with keen attention to detail.
  • Regularly updated knowledge of current trends and developments in Japanese medical device regulations.
  • Regulatory affairs certifications and memberships in relevant professional organizations (e.g., RAPS) are a plus