Senior Regulatory Affairs Specialist

1 month ago

Irvine, United States NeuroVasc Technologies, Inc. Full time

We are NeuroVasc Technologies We are committed to being the most dynamic creator of neurovascular devices in the world. We deliver excellence through innovation with integrity.


Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and execution; collaborate with Product Regulatory and Regional Regulatory Affairs colleagues to drive timely and accurate submission development and applications.


Duties and Responsibilities include...

  • Manages and coordinates international product registration submissions, oversees status of internal regional regulatory activities; ensures compliance with relevant regulations and standards.*
  • Leads Regulatory on Global product registrations in a timely manner to meet the needs of the business for product growth and geographical expansion.*
  • Actively engages with cross-functional teams (as required) to plan for and provide regulatory guidance, services, and capabilities to support planned product launch and market expansion.*
  • Coordinates (pre) submissions and approval of all applications, ensuring they are accurate and appropriate to the requirements of the regions.*
  • Plans and tracks specified product registration and renewal activity, ensuring alignment with portfolio priorities throughout the registration and renewal processes; manages expirations / renewals and planning for new applications.*
  • Manages and oversees relationships and interactions with Health Authorities (HAs) to ensure the company’s knowledge of requirements and expectations is current and robust; shares this regulatory intelligence with colleagues to ensure the company is informed of opportunities and risks.*
  • Participates in any relevant regulatory improvement projects.


Education and Experience:

  • Bachelor’s degree or higher in Life Sciences, Engineering, or related disciplines.
  • Minimum of 5 years’ plus experience in Regulatory Affairs.
  • Experience working with Class I, II and III medical devices.
  • Deep understanding of relevant laws, regulations, and guidelines governing the development, approval, and marketing of medical devices.
  • Proven knowledge of regulatory requirements and experience preparing international documents, such as STEDs, Design Dossier, and Technical Files and new products registration for Non-EU, Canada, LATAM, APAC (Australia, New Zealand, Korea, Taiwan, and Singapore), and EMEA.
  • Strong working knowledge of EU (MDD / MDR) medical device regulations and submissions.
  • Experience and proven ability in preparing US regulatory submissions e.g., IDE, 510(k), PMA, and technical documentation.
  • Knowledge of Quality Systems requirements such as QSR, ISO 13485, GxP.
  • Strong leadership and project management skills and ability to manage complex projects and timelines within a team environment.
  • Ability to identify compliance risks and escalate when necessary.
  • Demonstrated ability to stay abreast of changing regulations and standards.
  • Excellent computer aptitude and document formatting and publishing skills.
  • Strong problem-solving skills and ability to deal with changing priorities.


NeuroVasc is an equal opportunity employer.

Salary range is $100-$137K

  • Senior Specialist, Regulatory Affairs

    2 weeks ago

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

    Senior Specialist, Regulatory Affairs, Sustaining Products, THV The Regulatory Affairs Senior Specialist role is an outstanding opportunity to be a part of the Edwards Lifesciences Transcatheter Heart Valve (THV) program, one of the medical device industry’s most groundbreaking technological innovations. Edwards has a strong pipeline in this space and the...

  • Senior Specialist, Regulatory Affairs, Critical Care

    20 hours ago

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

    Senior Specialist, Regulatory Affairs, Critical Care Company: Edwards Lifesciences LLC Position: Req-33420 Location: Irvine, CA Posted: May 13, 2024 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 regulatory...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Irvine, United States Infosoft, Inc. Full time

    Job Title: Senior Regulatory Affairs SpecialistDuration: 9 monthsLocation: Irvine, CA (Onsite)Shift: 8 am to 5 pm.Our Client is a Global medical device Manufacturer.We are looking for a Senior Regulatory Affairs Specialist to complete and maintain regulatory approvals and clearances of assigned products.Create regulatory submissions (exercising judgment to...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Irvine, United States Infosoft, Inc. Full time

    Job Title: Senior Regulatory Affairs SpecialistDuration: 9 monthsLocation: Irvine, CA (Onsite)Shift: 8 am to 5 pm.Our Client is a Global medical device Manufacturer.We are looking for a Senior Regulatory Affairs Specialist to complete and maintain regulatory approvals and clearances of assigned products.Create regulatory submissions (exercising judgment to...

  • Senior Regulatory Affairs Specialist

    7 days ago

    Irvine, United States NeuroVasc Technologies, Inc. Full time

    We are NeuroVasc Technologies! We are committed to being the most dynamic creator of neurovascular devices in the world. We deliver excellence through innovation with integrity. Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning...

  • Senior Regulatory Affairs Specialist

    4 weeks ago

    Irvine, United States NeuroVasc Technologies, Inc. Full time

    We are NeuroVasc Technologies! We are committed to being the most dynamic creator of neurovascular devices in the world. We deliver excellence through innovation with integrity.Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and...

  • Regulatory Affairs Consultant

    6 days ago

    Irvine, United States Redbock - an NES Fircroft company Full time

    Regulatory Affairs Consultant Irvine, CA A fast-growing orthopedic Medical Device company in Irvine, CA is in immediate need of a Regulatory Affairs Consultant to support them for approximately 3 months . The consultant will need to work onsite at least 3 days/week . The Regulatory Affairs Consultant will be focused on the hands-on development of a Special...

  • Regulatory Affairs Consultant

    1 week ago

    Irvine, United States Redbock - an NES Fircroft company Full time

    Regulatory Affairs Consultant Irvine, CA A fast-growing orthopedic Medical Device company in Irvine, CA is in immediate need of a Regulatory Affairs Consultant to support them for approximately 3 months. The consultant will need to work onsite at least 3 days/week. The Regulatory Affairs Consultant will be focused on the hands-on development of a Special...

  • Regulatory Affairs Consultant

    2 weeks ago

    Irvine, United States Redbock - an NES Fircroft company Full time

    Regulatory Affairs ConsultantIrvine, CAA fast-growing orthopedic Medical Device company in Irvine, CA is in immediate need of a Regulatory Affairs Consultant to support them for approximately 3 months. The consultant will need to work onsite at least 3 days/week. The Regulatory Affairs Consultant will be focused on the hands-on development of a Special 510k...

  • Regulatory Affairs Specialist

    2 weeks ago

    Irvine, United States Cypress HCM Full time

    · 0-2 years of experience in regulatory affairs, and/or experience in QA, R&D, Manufacturing or Project Management within the IVD industry· Working knowledge of FDA, and CE marking requirements for IVD products is a plus· Able to work independently and with others· Able to work with minimal supervision· Excellent computer applications skills· Strong...

  • Regulatory Affairs Specialist

    2 weeks ago

    Irvine, United States Cypress HCM Full time

    · 0-2 years of experience in regulatory affairs, and/or experience in QA, R&D, Manufacturing or Project Management within the IVD industry· Working knowledge of FDA, and CE marking requirements for IVD products is a plus· Able to work independently and with others· Able to work with minimal supervision· Excellent computer applications skills· Strong...

  • Regulatory Affairs Specialist

    2 weeks ago

    Irvine, United States Cypress HCM Full time

    · 0-2 years of experience in regulatory affairs, and/or experience in QA, R&D, Manufacturing or Project Management within the IVD industry· Working knowledge of FDA, and CE marking requirements for IVD products is a plus· Able to work independently and with others· Able to work with minimal supervision· Excellent computer applications skills· Strong...

  • Regulatory Affairs Specialist- Irvine

    2 weeks ago

    Irvine, United States Hydrogen Group Full time

    Are you passionate about navigating global regulatory landscapes and ensuring the compliance of life-saving medical devices? We're looking for a skilled Regulatory Affairs Specialist to join a vibrant team in Irvine, CA! This medical device company are pioneering innovative medical solutions that enhance patient care worldwide. Their International...

  • Regulatory Affairs Specialist

    2 weeks ago

    Irvine, United States Trinus Full time

    Job DescriptionJob DescriptionSummary: The main function of a regulatory affairs specialist is to complete and maintain regulatory approvals and clearances of assigned products.Key Responsibilities: Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and...

  • Director, Safety. Regulatory Affairs and Medical Affairs Quality Standards

    5 days ago

    Irvine, California, United States AbbVie Full time

    Job Description Purpose: AbbVie is dedicated to delivering a consistent stream of innovative, safe, and effective quality medicines and products that solve serious health issues and have a remarkable impact on people’s lives. As a quality organization in research & development, R&D Quality Assurance (RDQA) is committed to driving quality excellence...

  • Senior Regulatory Affairs Specialist

    1 week ago

    Irvine, United States Cynet Systems Full time

    Job Description:Pay Range $44.60hr - $49.60hrResponsibilities:Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy.Participate in providing guidance on strategies and...

  • Senior Regulatory Affairs Specialist

    1 week ago

    Irvine, United States Cynet Systems Full time

    Job Description: Pay Range $44.60hr - $49.60hr Responsibilities: Create regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, participate in developing regulatory strategy. Participate in providing guidance on strategies and...

  • Senior Regulatory Labeling Specialist

    1 week ago

    Irvine, United States Medtronic, plc Full time

    Help with development of US and International regulatory strategies for product submissions. Assist in keeping company informed of regulatory requirements in the US and International Regions Participate on Product Development teams, providing regulat Regulatory, Neuro, Senior, Specialist, International, Technical, Manufacturing, Technology

  • Sr. RA Specialist

    7 days ago

    Irvine, United States Tandym Group Full time

    A recognized services company in California is currently seeking an experienced Regulatory Affairs Specialist to join their staff in the Greater Los Angeles area in a Senior-level position. Responsibilities: The Senior Regulatory Affairs Specialist will: Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory...

  • Manager, Regulatory Affairs

    4 weeks ago

    Irvine, California, United States Allergan Aesthetics Full time

    Job Description   Description     The Manager Regulatory Affairs represents US regulatory affairs for device development projects. Executes US regulatory strategic plans and provides guidance to Global Regulatory Lead (GRL) and project team. Plans and prepares complex regulatory submission documents primarily for US regulatory filings. Utilizing...