Current jobs related to Lead Regulatory Affairs Expert - Irvine, California - NeuroVasc Technologies, Inc.

  • Regulatory Affairs Director

    4 weeks ago

    Irvine, California, United States DIALITY INC Full time

    Job DescriptionDiality Inc, a pioneering medical device company based in Irvine, CA, is dedicated to revolutionizing the treatment of kidney disease. Our cutting-edge, portable hemodialysis machine will empower patients to self-treat at home or on-the-go, breaking free from the constraints of traditional dialysis methods. As a key member of our team, you...

  • Regulatory Affairs Director

    2 weeks ago

    Irvine, California, United States Diality Full time

    Job Title: Director of Regulatory AffairsCompany Overview:Diality Inc, a privately held medical device company, 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.Job Summary:The Director of...

  • Regulatory Affairs Specialist

    1 month 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

    1 week ago

    Irvine, California, United States Orion Group Full time

    Job SummaryOrion Group is seeking a highly skilled Regulatory Affairs Specialist to support the development and implementation of the global regulatory strategy for company cosmetic and OTC products.The ideal candidate will have a strong understanding of personal care product industry regulatory affairs discipline throughout the product lifecycle, including...

  • Regulatory Affairs Specialist

    2 weeks ago

    Irvine, California, United States Spectraforce Technologies Full time

    Job Title: Regulatory Affairs SpecialistSpectraforce Technologies is seeking a highly skilled Regulatory Affairs Specialist to support the development and implementation of the global regulatory strategy for SkinMedica products.Key Responsibilities:Review and prepare regulatory documents and labeling for cosmetic or OTC product registrations/updates.Research...

  • Regulatory Affairs Director

    2 weeks ago

    Irvine, California, United States Diality Full time

    Job Title: Director of Regulatory AffairsDiality Inc, a privately held medical device company, is seeking a highly skilled Director of Regulatory Affairs to oversee the development and implementation of regulatory strategies for our innovative hemodialysis machine. As a key member of our team, you will be responsible for ensuring compliance with global...

  • Regulatory Affairs Specialist

    1 month 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 Director

    3 days ago

    Irvine, California, United States Diality Full time

    Job Title: Regulatory Affairs DirectorCompany: Diality IncLocation: Irvine, CAJob Type: Full-timeAbout Us: Diality Inc is a privately held medical device company committed to improving the quality of life for patients with kidney disease.Job Description:We are seeking a highly experienced Regulatory Affairs Director to oversee, develop, and influence...

  • Regulatory Affairs Specialist

    3 weeks ago

    Irvine, California, United States Roth Staffing Companies Full time

    Regulatory Affairs SpecialistJob Summary:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Roth Staffing Companies. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements for medical device products.Key Responsibilities:Represent the regulatory function on manufacturing...

  • Regulatory Affairs Specialist

    2 weeks ago

    Irvine, California, United States Ledgent Technology Full time

    Job Title: Sr Regulatory Affairs SpecialistRoth Staffing is seeking a highly skilled Sr Regulatory Affairs Specialist to join our team in Irvine, CA. This is an exciting opportunity to work for a global leader in life-saving medical devices with a strong corporate culture and competitive pay.Job Summary:The Sr Regulatory Affairs Specialist will be...

  • Regulatory Affairs Specialist

    2 weeks ago

    Irvine, California, United States Ledgent Technology Full time

    Job Title: Sr Regulatory Affairs SpecialistRoth Staffing is seeking a highly skilled Sr Regulatory Affairs Specialist to join our team in Irvine, CA. This is an exciting opportunity to work for a global leader in life-saving medical devices with a strong corporate culture and competitive pay.Job Summary:The Sr Regulatory Affairs Specialist will be...

  • Regulatory Affairs Specialist

    4 days ago

    Irvine, California, United States Tucker Parker Smith Group (TPS Group) Full time

    Regulatory Affairs SpecialistTucker Parker Smith Group (TPS Group) is seeking a skilled Regulatory Affairs Specialist to support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities for a medical device client. The ideal candidate will have a strong background in regulatory affairs and experience with CE marking requirements for IVD...

  • Regulatory Affairs Specialist

    2 weeks ago

    Irvine, California, United States TalentBurst, an Inc 5000 company Full time

    Regulatory Affairs Specialist Job DescriptionTalentBurst, an Inc 5000 company, is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for medical devices.Key Responsibilities:Compile and maintain regulatory...

  • Regulatory Affairs Specialist

    2 weeks ago

    Irvine, California, United States Trinus Corporation Full time

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Trinus Corporation. As a key member of our team, you will be responsible for ensuring the compliance of our medical devices with regulatory requirements.Key Responsibilities:Represent regulatory interests on product development teams, providing...

  • Senior Regulatory Affairs Specialist

    4 weeks ago

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

    Senior Regulatory Affairs SpecialistWe are NeuroVasc Technologies, a company that delivers excellence through innovation with integrity.This role is on-site and reports directly to the CEO. The Senior Regulatory Specialist is responsible for planning, directing, and coordinating global product registrations and leading regulatory submissions planning and...

  • Regulatory Affairs Specialist

    2 weeks ago

    Irvine, California, United States Cynet Systems Full time

    Job Title: Regulatory Affairs SpecialistCynet Systems is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory function, you will provide input on regulatory requirements and ensure compliance with global regulations.Key Responsibilities:Represent the regulatory function on manufacturing and product...

  • Regulatory Affairs Specialist

    2 weeks ago

    Irvine, California, United States Planet Pharma Full time

    Job Title: Sr. Regulatory Affairs SpecialistPlanet Pharma is seeking a highly skilled Sr. Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring the compliance of our medical device products with global regulatory requirements.Key Responsibilities:Represent the regulatory function on...

  • Director of Regulatory Affairs and Strategic Labeling

    1 week ago

    Irvine, California, United States AbbVie Full time

    About AbbVieAbbVie is a leading global biopharmaceutical company that discovers and delivers innovative medicines and solutions to address serious health issues.Job DescriptionThe Director of Regulatory Affairs and Strategic Labeling will play a critical role in setting strategy and leading cross-functional teams to execute labeling activities for drugs,...

  • Regulatory Affairs Specialist

    1 month ago

    Irvine, California, United States Fluxergy Full time

    About UsFluxergy is a rapidly growing in vitro diagnostics company that is revolutionizing laboratory testing with its innovative multi-modal point-of-care platform. Our platform enables molecular, clinical chemistry, immunoassay, and hematology testing on the same system, making it a game-changer in the industry.Our MissionWe are seeking a highly motivated...

  • Regulatory Affairs Specialist

    1 month ago

    Irvine, California, United States Tucker Parker Smith Group (TPS Group) Full time

    Regulatory Affairs Specialist IILocation: Irvine, CA (Hybrid 3 days on site)12 month AssignmentPay Rate: $45-$49/hr.We are seeking a Regulatory Affairs Specialist to support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities for a medical device client. The successful candidate will be responsible for revising technical files, attending...

Lead Regulatory Affairs Expert

2 months ago

Irvine, California, United States NeuroVasc Technologies, Inc. Full time
Company Overview:
NeuroVasc Technologies, Inc. is committed to delivering excellence through innovation and integrity.


Position Summary:
The Senior Regulatory Affairs Specialist will report directly to the CEO and will be tasked with planning, directing, and coordinating global product registrations. This role will also lead the planning and execution of regulatory submissions, collaborating with Product Regulatory and Regional Regulatory Affairs teams to ensure timely and accurate submission development.

Key Responsibilities:
  • Oversee and manage international product registration submissions, ensuring compliance with applicable regulations and standards.
  • Lead global product registrations to support business growth and geographical expansion.
  • Engage with cross-functional teams to provide regulatory guidance and support for product launches and market expansion.
  • Coordinate the preparation and approval of all applications, ensuring accuracy and compliance with regional requirements.
  • Plan and monitor product registration and renewal activities, aligning with portfolio priorities and managing expirations and new applications.
  • Maintain relationships with Health Authorities to ensure current knowledge of regulatory requirements and share insights with colleagues.
  • Participate in relevant regulatory improvement initiatives.
Qualifications:
  • Bachelor's degree or higher in Life Sciences, Engineering, or related fields.
  • Over 5 years of experience in Regulatory Affairs.
  • Experience with Class I, II, and III medical devices.
  • In-depth understanding of laws, regulations, and guidelines for medical device development, approval, and marketing.
  • Proven experience in preparing international regulatory documents, including STEDs, Design Dossier, and Technical Files.
  • Strong knowledge of EU medical device regulations (MDD/MDR) and US regulatory submissions (IDE, 510(k), PMA).
  • Familiarity with Quality Systems requirements such as QSR, ISO 13485, and GxP.
  • Excellent leadership and project management skills, with the ability to manage complex projects within a team.
  • Ability to identify compliance risks and escalate as necessary.
  • Demonstrated capacity to stay updated on changing regulations and standards.
  • Strong computer skills and proficiency in document formatting and publishing.
  • Effective problem-solving skills and adaptability to changing priorities.

NeuroVasc is an equal opportunity employer.
Salary range is $100-$150K