Regulatory Affairs Specialist

1 month ago

Irvine, California, United States Ledgent Technology Full time
Job Title: Sr Regulatory Affairs Specialist

Roth 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 responsible for completing and maintaining regulatory approvals and clearances of medical device products. This includes representing the regulatory function on manufacturing and product development teams, reviewing and approving protocols, reports, and documentation to ensure regulatory requirements compliance, and providing guidance on regulatory requirements necessary for strategic and contingency planning.

Key Responsibilities:
  • Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements and present alternatives for meeting regulatory requirements.
  • Review and approve protocols, reports, and documentation to ensure regulatory requirements compliance, consistency, and accuracy.
  • Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing preliminary regulatory strategic plans and preparing documentation packages for submission to global regulatory agencies.
  • Interact with regulatory agencies as part of submission review and on-site audit support.
  • Monitor proposed and current global regulations and guidance, assess their impact on assigned projects, and propose suggestions on utilizing regulatory updates to expedite the approval process.
  • Review labeling content, product and process changes, and product documentation to ensure regulatory requirements compliance, consistency, and accuracy.
Requirements:
  • Bachelor's Degree or equivalent in a scientific discipline (e.g., Biology, Microbiology, Chemistry).
  • 5-7 years of experience required, with experience with EU MDR strongly preferred.
  • Coursework, seminars, and/or other formal government and/or trade association training required.
  • Proven expertise in Microsoft Office, Adobe, and experience in product lifecycle management systems (Agile, Teamcenter, etc.) preferred.
  • Excellent written and verbal communication skills, interpersonal relationship skills, problem-solving, organizational, analytical, and critical thinking skills.

Roth Staffing is an equal opportunity employer and welcomes applications from all qualified candidates. We consider all qualified applicants without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status.

  • Regulatory Affairs Specialist

    4 weeks 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

    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...

  • 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

    2 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...

  • Regulatory Affairs Director

    3 weeks 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...

  • 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,...

  • Director, Quality Assurance and Regulatory Affairs

    3 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...

  • Clinical Affairs Manager

    4 weeks ago

    Irvine, California, United States Edwards Lifesciences Full time

    We're seeking a highly skilled Clinical Affairs Manager to join our team at Edwards Lifesciences. As a key member of our Clinical Affairs team, you'll play a critical role in driving the evidence needed to optimize patient outcomes.In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory...

  • Scientific Medical Affairs Director

    4 weeks ago

    Irvine, California, United States AbbVie Full time

    Job OverviewAbbVie is seeking a highly skilled Associate Director, Scientific Medical Affairs to join our team. As a key member of our Medical Affairs department, you will play a critical role in developing and executing medical strategies for our migraine portfolio, including onabotulinumtoxinA (onabotA).Key ResponsibilitiesContribute to the development of...

  • Senior Director, Scientific Affairs for Aesthetics and Reconstruction Expert

    3 weeks ago

    Irvine, California, United States J&J Family of Companies Full time

    Job DescriptionWe are seeking a highly skilled Senior Director, Scientific Affairs for Aesthetics and Reconstruction to join our team at J&J Family of Companies.Key ResponsibilitiesProvide strategic direction to members of the medical affairs department.Oversee large and complex clinical trials, ensuring consistency across program studies.Provide counsel on...

  • Regulatory Banking Specialist

    3 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...

  • Network Director, Medical Staff Services

    3 weeks ago

    Irvine, California, United States AbbVie Full time

    Job SummaryAmbitious and results-driven professional sought for the role of Network Director, Medical Staff Services at AbbVie. The ideal candidate will possess a strong background in quality assurance and regulatory affairs, with a proven track record of driving quality excellence across all stages of discovery and development.Key ResponsibilitiesOversee...

  • 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...

  • Anesthesiology Specialist

    4 weeks ago

    Irvine, California, United States Kaiser Permanente Full time

    Job Summary:Anesthesiology Specialist at Kaiser Permanente provides anesthesia services to patients undergoing various surgical, obstetrical, and other procedures. The specialist administers general and regional anesthesia, monitors patients' vital signs, and responds to emergencies. They work under the medical supervision of an anesthesiologist and adhere...

  • Scientific Communications Director

    3 weeks ago

    Irvine, California, United States Allergan Aesthetics Full time

    Job OverviewAt Allergan Aesthetics, we are seeking a highly skilled Associate Director, Scientific Communications and Training to lead the development and implementation of industry-leading training and scientific education for our Medical Affairs organization.This role will be responsible for planning and developing key scientific training resources and...

  • Wetlands Permitting Specialist

    3 weeks ago

    Irvine, California, United States Aztec Engineering Group, Inc, Full time

    Job Title: Wetlands Permitting SpecialistWe are seeking a highly skilled Wetlands Permitting Specialist to join our team at Aztec Engineering Group, Inc. in Irvine, California. As a key member of our environmental team, you will be responsible for ensuring compliance with federal, state, and local regulations related to wetlands and water resources.Key...

  • Technical Content Specialist

    1 month ago

    Irvine, California, United States Volt Full time

    Job Summary:Volt is seeking a skilled Technical Content Specialist to join our team in Irvine, CA. As a Technical Content Specialist, you will be responsible for creating high-quality technical documents, including procedures, manuals, and work instructions, for our engineering and medical device teams. You will work closely with engineers to ensure that our...

  • PCI Compliance Specialist

    4 weeks ago

    Irvine, California, United States ESPO Full time

    Job Title: PCI Compliance SpecialistAt ESPO Corporation, we are seeking a highly skilled PCI Compliance Specialist to join our team. As a PCI Compliance Specialist, you will be responsible for managing and building a PCI DSS program, ensuring compliance with industry standards and regulations. Key Responsibilities:Develop and implement PCI DSS compliance...

  • Quality Assurance Specialist

    4 weeks ago

    Irvine, California, United States Innova Solutions Full time

    Quality Assurance SpecialistInnova Solutions is seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services. This includes conducting inspections, testing, and audits to ensure compliance with regulatory requirements and company standards.Key...

  • 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,...