Regulatory Affairs Specialist

4 weeks ago


Aliso Viejo, California, United States MicroVention Full time

Job Title: Regulatory Affairs Specialist

Job Summary:

This position is responsible for assisting in obtaining regulatory approvals and ensuring compliance to FDA and international regulatory agency requirements, including ISO, local, state, and/or federal requirements.

Key Responsibilities:

  • Serves as a member on project teams completing tasks as assigned by the team.
  • Aides in the execution of the regulatory plan for the assigned market(s) based on the approved regulatory strategy.
  • Assists in preparing regulatory submissions to ensure MicroVention devices are commercially available in the assigned market(s) based on the approved regulatory strategy.
  • Documents, consolidates, and maintains verbal and written communication with regulatory agencies.
  • Maintains regulatory files and records.
  • Assists in reviewing change order documents and ascertains impact on current regulatory approvals.
  • Assists with technical publishing of submissions.
  • Supports and contributes to editing/revising Standard Operating Procedures.
  • Builds team cohesiveness by supporting team members.

Requirements:

  • Minimum BA/BS degree in a scientific or technical discipline or relevant field of study.
  • Advanced degree may offset medical device industry experience.
  • Minimum of three (3) years of Medical device industry experience.
  • Desired Qualifications:
    • Minimum one (1) year Regulatory Affairs Experience.
    • Leadership skills.
    • Ability to work well in a team environment.
    • Detail oriented.
    • Proven analytical abilities and organization skills.
    • Ability to comprehend technical documents and concepts.
    • Proficient computer skills (e.g., MS Office).

Equal Opportunity Employer: MicroVention is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.



  • Aliso Viejo, California, United States RxSight, Inc. Full time

    Job SummaryRxSight, Inc. is seeking a highly skilled Customer Experience Specialist to join our team. As a key member of our customer support team, you will be responsible for delivering exceptional customer service and ensuring the highest level of customer satisfaction.Key ResponsibilitiesTrain on QAD ERP System and RxSight technology, including products...


  • Aliso Viejo, California, United States RxSight, Inc. Full time

    RxSight, Inc. is a leading ophthalmic medical technology corporation that has commercialized the world's first and only adjustable intraocular lens (IOL) that is customized after cataract surgery.The company's mission is to revolutionize the premium cataract surgery experience by allowing surgeons to partner with their patients to achieve optimized results...


  • Aliso Viejo, California, United States RxSight, Inc. Full time

    Job Summary:RxSight, Inc. is seeking a Quality Assurance Specialist to support the company's mission to revolutionize the premium cataract surgery experience. The successful candidate will perform quality functions to ensure compliance with regulatory requirements, manage quality systems, and provide support to the manufacturing team.Key...


  • Aliso Viejo, California, United States Vertex Ventures HC Full time

    About Vertex Ventures HC:At Vertex Ventures HC, we are dedicated to advancing innovative solutions in ophthalmic care. Our team of experts is committed to developing cutting-edge technologies that address unmet needs in glaucoma and cataract surgery/intraocular lens replacement.Our Mission:We strive to create a paradigm shift in global eye care by fostering...


  • Mission Viejo, California, United States South Orange County Community College District Full time

    Job SummaryThe South Orange County Community College District is seeking a highly qualified individual to fill the position of Director of Nursing and Assistant Dean of Health and Wellness. This role will provide leadership and direction to the nursing program, as well as serve as a key member of the Health and Wellness team.Key ResponsibilitiesProvide...


  • Mission Viejo, California, United States BMS CAT Full time

    At BMS CAT, we're committed to providing top-notch disaster restoration services. As an Environmental Technician, you'll play a crucial role in ensuring our processes meet the highest standards of compliance and safety.Key Responsibilities:Engage in practices to maintain regulatory requirements and safety standards. Assist on asbestos abatement jobs.What We...


  • Mission Viejo, California, United States Providence Health & Service Full time

    Job DescriptionThe Patient Relations Specialist collaborates with caregivers and hospital departments to provide a service-centered experience for patients and families. This role serves within the department of Patient Experience, Human Resources, and is accountable for the operational implementation of the ministry-wide Patient Experience goals,...


  • Mission Viejo, California, United States Prime Healthcare Full time

    OverviewMission Regional Medical Center is a leading healthcare provider in the Rio Grande Valley, offering a range of medical and surgical services, including a 24/7 emergency room. As a Radiology Tech, you will play a critical role in delivering high-quality patient care and contributing to the hospital's mission to provide exceptional healthcare...


  • Mission Viejo, California, United States Prime Healthcare Full time

    OverviewMission Regional Medical Center is a leading healthcare provider in the Rio Grande Valley, offering a range of medical and surgical services, including a 24/7 emergency room. We are committed to providing high-quality patient care and a positive work environment for our employees.ResponsibilitiesThe Radiology Technician/CT Technologist performs...


  • Mission Viejo, California, United States Lifepoint Rehabilitation Full time

    Job Summary:As an Occupational Therapist at Lifepoint Rehabilitation, you will play a vital role in helping patients regain their independence and well-being through exercise and the use of prosthetic and orthotic devices. You will develop specialized treatment plans, communicate patient progress, and document care in accordance with regulatory...


  • Mission Viejo, California, United States South Orange County Community College District Full time

    Job SummaryThe South Orange County Community College District is seeking a highly qualified and experienced individual to fill the position of Nursing Program Director and Assistant Dean of Health and Wellness. This is a unique opportunity to lead and manage the nursing program, providing leadership and direction to develop, organize, and implement program...


  • Aliso Viejo, United States MicroVention Full time

    Job DescriptionResponsible for supporting and leading the management of Professional Affairs and Clinical Education initiatives and programs to maintain and expand the worldwide adoption of MicroVention products. Provide leadership with MVI programs including but not limited to; Proctoring Programs, Clinical Immersion Programs (CIPs), and Mentorship Programs...


  • Aliso Viejo, United States MicroVention Full time

    Job DescriptionResponsible for supporting and leading the management of Professional Affairs and Clinical Education initiatives and programs to maintain and expand the worldwide adoption of MicroVention products. Provide leadership with MVI programs including but not limited to; Proctoring Programs, Clinical Immersion Programs (CIPs), and Mentorship Programs...

  • Corridor Specialist

    3 months ago


    Aliso Viejo, United States Cherokee Nation Businesses Full time

    Job Description This position requires an active Public Trust clearance or the ability to obtain a Public Trust clearance to be considered. The Corridor Specialist will assist with CBP's acquisition; building operations, maintenance and repair (BOMR); and funding management and budget tasks Compensation & Benefits: Estimated Starting Salary Range for...


  • Aliso Viejo, United States MicroVention Full time

    Job Description Manage individuals from entry-level to mid-level experience, develop and launch products, research new ideas, and manage overall design history. Focus is on both theoretical and practical solution development through the application of the scientific process and project management. Job duties: Manage a group of individuals of varying...


  • Aliso Viejo, United States MicroVention Full time

    Job Description Manage individuals from entry-level to mid-level experience, develop and launch products, research new ideas, and manage overall design history. Focus is on both theoretical and practical solution development through the application of the scientific process and project management. Job duties: Manage a group of individuals of varying...


  • Aliso Viejo, United States RxSight, Inc. Full time

    Job Type Full-time Description RxSight® is an ophthalmic medical technology corporation headquartered in Aliso Viejo, California that has commercialized the world's first and only adjustable intraocular lens (IOL) that is customized after cataract surgery. The company's mission is to revolutionize the premium cataract surgery experience by allowing surgeons...


  • Aliso Viejo, United States Vaco Full time

    Needs to be local Contract to hire Pay: $47-66/hrPosition Overview Serve as the owner for managing and maintaining database platforms, as well as a technical contributor to the implementation and/or enhancement of various software applications and business reports utilized across the organization. Ensure the smooth operation and integrity of databases while...


  • Aliso Viejo, United States Vaco Remote Work Freelance Full time

    Needs to be localContract to hirePay: $47-66/hrPosition OverviewServe as the owner for managing and maintaining database platforms, as well as a technical contributor to the implementation and/or enhancement of various software applications and business reports utilized across the organization. Ensure the smooth operation and integrity of databases while...


  • Mission Viejo, United States Providence Health & Service Full time

    Job DescriptionThe Patient Relations Specialist collaborates with caregivers and hospital departments to provide a service-centered experience for patients and families. The Patient Relations Specialist serves within the department of Patient Experience, Human Resources. The representative role provides support and is accountable for the operational...


  • Mission Viejo, United States Providence Health & Service Full time

    Job Description The Patient Relations Specialist collaborates with caregivers and hospital departments to provide a service-centered experience for patients and families. The Patient Relations Specialist serves within the department of Patient Experience, Human Resources. The representative role provides support and is accountable for the operational...