Current jobs related to Regulatory Operations Specialist - Irvine, California - Entegee

  • Regulatory Affairs Specialist

    1 month 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 weeks 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...

  • Director of Regulatory Operations

    1 month ago

    Irvine, California, United States CG ONCOLOGY INC Full time

    Join Our Team as a Director of Regulatory OperationsAt CG Oncology, we are seeking a highly skilled and experienced Director of Regulatory Operations to join our team. As a key member of our regulatory operations team, you will be responsible for providing strategic leadership and direction in the planning, preparation, and publishing of electronic...

  • Regulatory Banking Specialist

    4 weeks ago

    Irvine, California, United States HSBC Full time

    We're committed to creating a better world for our customers, people, investors, communities, and the planet. As a Regulatory Banking Specialist, you'll play a pivotal role in supporting our relationship management team.This role is part of our overall relationship team, providing key support to our valuable banking and wealth clients. You'll work closely...

  • Regulatory Affairs Specialist II

    2 weeks ago

    Irvine, California, United States Yoh, A Day & Zimmermann Company Full time

    Job OverviewYoh, A Day & Zimmermann Company, is seeking a highly skilled Regulatory Affairs Specialist II to join our team. As a Regulatory Affairs Specialist II, you will be responsible for supporting the EU's In Vitro Diagnostic Regulation (IVDR) transition activities, preparing revision of technical files, updating labeling to comply with IVDR...

  • Regulatory Affairs Professional

    3 weeks ago

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

    Regulatory Affairs SpecialistJob DescriptionAt Tucker Parker Smith Group (TPS Group), we are seeking a highly skilled Regulatory Affairs Specialist to support our client's EU's In Vitro Diagnostic Regulation (IVDR) transition activities. The successful candidate will work on revising technical files, attending meetings, and supporting labeling conversion...

  • Financial Operations Specialist

    3 weeks ago

    Irvine, California, United States Supernal Full time

    At Supernal, we are committed to creating a sustainable, integrated, and human-centered ecosystem for Advanced Air Mobility (AAM). As a key member of our team, the Financial Operations Specialist - Medical Field will play a crucial role in supporting the day-to-day financial operations of the company.This role is responsible for ensuring accurate and timely...

  • Senior Regulatory Compliance Program Specialist

    4 weeks ago

    Irvine, California, United States Xe Full time

    Job OverviewXe is seeking a highly skilled Senior Regulatory Compliance Program Analyst to join our team. As a key member of our Compliance function, you will play a critical role in ensuring the company's compliance with regulatory requirements and internal policies.The ideal candidate will have a strong background in regulatory compliance, with a minimum...

  • Director of Regulatory Affairs and Strategic Labeling

    4 weeks 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,...

  • Operations Director

    4 weeks ago

    Irvine, California, United States Pacific Neuropsychiatric Specialists Full time

    Job SummaryPacific Neuropsychiatric Specialists is seeking a highly skilled Director of Operations to oversee the daily operations of its clinical locations. The ideal candidate will have a proven track record of managing multi-functional teams and a strong understanding of medical compliance requirements.Key ResponsibilitiesProvide day-to-day leadership and...

  • Director, Quality Assurance and Regulatory Affairs

    4 weeks ago

    Irvine, California, United States AbbVie Full time

    About the Role:Absorb the challenge of leading a global team of quality assurance professionals in AbbVie's Research and Development organization. As Director, Quality Assurance and Regulatory Affairs, you will be responsible for ensuring the highest standards of quality in our products and processes.Key Responsibilities:Lead the development and...

  • Vehicle Operations Specialist

    4 weeks ago

    Irvine, California, United States Kett Engineering Full time

    Job DetailsJob SummaryKett Engineering is seeking a skilled Vehicle Operations Specialist to join our Test and Development team. As a Vehicle Operations Specialist, you will be responsible for operating, driving, troubleshooting, and evaluating our prototype test vehicles.Key ResponsibilitiesSafely operate test vehicles in a wide range of testing conditions...

  • Operations Specialist

    4 weeks ago

    Irvine, California, United States SCal Mobile Full time

    Job OverviewWe are seeking a detail-oriented Operations Specialist to collaborate with our production, quality assurance, and warehouse operations teams.The ideal candidate will be a self-motivated problem-solver who can thrive in a fast-paced, team-oriented setting.Key Responsibilities:Process, test, and categorize mobile devices.Work closely with...

  • Operations Director

    4 weeks ago

    Irvine, California, United States Pacific Neuropsychiatric Specialists Full time

    Job Summary:Pacific Neuropsychiatric Specialists is seeking a highly skilled Director of Clinical Operations to oversee the daily operations of its clinical locations. The ideal candidate will have a proven track record of managing multi-functional teams and ensuring high-quality patient care.Key Responsibilities:Provide day-to-day leadership and guidance to...

  • Property Management Specialist

    4 weeks ago

    Irvine, California, United States Indotronix International Corporation Full time

    Job SummaryWe are seeking a highly skilled Property Management Specialist to join our team at Indotronix International Corporation. As a key member of our property management team, you will be responsible for supporting our wireless real estate operations in the Southern California market.Your primary duties will include interacting with landlords,...

  • Quality Assurance Specialist

    4 weeks ago

    Irvine, California, United States Cypress HCM Full time

    Job DescriptionCypress HCM is seeking a skilled Quality Assurance Specialist to join our team. In this role, you will be responsible for operating, maintaining, calibrating, and troubleshooting clinical diagnostic laboratory instruments.Key Responsibilities:Operate and maintain clinical diagnostic laboratory instruments to ensure accurate and reliable test...

  • Facilities Operations Specialist

    4 weeks ago

    Irvine, California, United States Kia America Full time

    Job Title: Facilities SpecialistAt Kia America, we're committed to creating a culture of innovation and collaboration. As a Facilities Specialist, you'll play a critical role in supporting our facilities operations, ensuring seamless day-to-day operations, and driving business growth.Key Responsibilities:Manage facilities-related budgets, invoices, and...

  • Mission Operations Specialist

    4 weeks ago

    Irvine, California, United States Turion Space Full time

    Job Title: Mission Operations SpecialistJob Summary:We are seeking a highly skilled Mission Operations Specialist to join our team at Turion Space. As a key member of our operations team, you will be responsible for the collection of critical telemetry data from our satellite operations, ensuring mission success.Key Responsibilities:Perform real-time ground...

  • Facilities Operations Specialist

    4 weeks ago

    Irvine, California, United States iParametrics LLC Full time

    Job Title: Facilities Operations SpecialistJob Summary:iParametrics LLC is seeking a skilled Facilities Operations Specialist to join our team. The ideal candidate will possess expertise in warranty management, post-project close-out, and pre-functional resting. This role will play a critical role in ensuring the smooth operation of facilities and...

  • Facilities Management Specialist

    4 weeks ago

    Irvine, California, United States Hydration Room, Inc. Full time

    We are seeking a highly skilled Facilities Management Specialist to oversee the facilities management, maintenance, safety, and risk mitigation of Hydration Room's 30+ locations. This role will be responsible for managing all facility-related needs, from routine maintenance to emergency responses, and will work closely with operational teams to ensure a safe...

Regulatory Operations Specialist

1 month ago

Irvine, California, United States Entegee Full time
Job Summary

Entegee is seeking a highly skilled Regulatory Operations Specialist to manage submission publishing, device listings, and UDI data collection for medical devices in the US and EU markets.

Key Responsibilities:

  • Lead submission content management and submission publishing for US and EU markets
  • Manage regulated master data, including UDI data collection and submission
  • Assess new and changing regulations to ensure compliance
  • Update regulatory processes and QMS procedures as needed
  • Maintain device listings, product licensing, and facility registrations
  • Provide audit support for FDA, NB, and international regulatory agency audits
  • Collaborate with cross-functional teams to prepare submission content and maintain overall regulatory compliance

Requirements:

  • 3-4 years of experience in Regulatory Operations within the medical device industry
  • Bachelor's Degree
  • Experience with submission publishing, device listings, and UDI data collection and reporting
  • Familiarity with QMS updates and providing audit support for FDA, NB, and international agencies
  • Experience with RIM systems, Power BI, and Business Objects
  • Understanding of US and EU medical device regulations, including submissions, change notifications, and regulatory assessments

Benefits:

  • Medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits, and 401K plan
  • Equal Opportunity Employer/Veterans/Disabled