Current jobs related to Clinical Affairs Specialist - Irvine, California - AVITA Medical

  • Clinical Affairs Specialist

    3 weeks ago

    Irvine, California, United States Fluxergy Europe gmbh 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 committed to decentralizing...

  • Clinical Affairs Manager

    1 week 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...

  • 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 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

    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

    3 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

    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

    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

    4 weeks 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

    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

    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 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...

  • 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...

  • 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...

  • 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...

  • 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 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...

  • Scientific Affairs Liaison

    4 weeks ago

    Irvine, California, United States Provident Research Inc Full time

    Job Title: Scientific Affairs Liaison - Ophthalmology DevicesAs a key member of our team, you will play a critical role in ensuring the effective communication of our cutting-edge ophthalmology research to both internal and external stakeholders. Your work will directly support the development of new products and technologies that deliver significant...

  • 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...

Clinical Affairs Specialist

2 months ago

Irvine, California, United States AVITA Medical Full time

Position Title: Medical Affairs Associate

Location: Irvine, CA

Reports to: Medical Affairs Manager

Compensation: Base salary plus bonus

Travel: Up to 15% as required.

Company Overview: Avita Medical is at the forefront of regenerative medicine, focusing on the innovation and commercialization of devices and autologous cellular therapies aimed at skin restoration. Our FDA-approved RECELL System technology platform is designed to treat patients suffering from thermal burn injuries and full-thickness skin defects, as well as facilitating the re-pigmentation of stable depigmented vitiligo lesions by utilizing the regenerative capabilities of the patient's own skin to produce Spray-on Skin cells.

POSITION SUMMARY:

The Medical Affairs Associate plays a vital role within the Medical Affairs Department, contributing to the creation and upkeep of medical information and communications. This position involves developing scientifically sound materials for healthcare professionals, regulatory authorities, internal teams, and investors.

KEY RESPONSIBILITIES:

  • Conduct data analysis and provide medical writing support to both internal and external stakeholders.
  • Collaborate closely with the Medical Science Liaison (MSL) team to assist in the creation and submission of abstracts.
  • Support the development of clinical studies, abstracts, and training presentations.
  • Oversee medical affairs initiatives related to post-market surveillance.
  • Maintain internal documentation, including bibliographies and medical communication strategies.
  • Assist in responding to inquiries from healthcare professionals, consumers, and investors regarding products and medical information.

KEY REQUIREMENTS:

  • Advanced degree in a medical field, life sciences, or public health is preferred.
  • Exceptional written and verbal communication skills.
  • Proficient in Microsoft Word, PowerPoint, and Excel.
  • Understanding of medical communication strategies.
  • Able to work independently as well as collaboratively within a team.
  • Capable of managing multiple projects concurrently.
  • Strong attention to detail and excellent organizational skills.
  • Experience in medical writing, including study protocols, data analysis, abstracts, posters, manuscripts, and presentations.
  • Familiarity with post-market surveillance programs for regulatory compliance.
  • Knowledge of handling unsolicited requests for information and off-label inquiries.

EEOC: Avita Medical is an Equal Opportunity Employer. We value diversity and are dedicated to fostering an inclusive environment for all employees. All employment decisions are based on qualifications, merit, and business needs.

Work Environment: The physical demands outlined here are representative of those that must be met by an individual to successfully perform the essential functions of this role. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

While performing the duties of this position, the employee is regularly required to sit, talk, and hear, as well as stand, walk, and/or balance. The individual must be able to use hands and fingers to type, handle, feel, grasp, push, and pull. Hand-eye coordination is necessary for operating computers and various office equipment. Specific vision abilities required for this role include close vision and the ability to adjust focus. The individual may frequently need to reach with hands and arms and may occasionally be required to stoop, kneel, or crouch. The individual may occasionally lift and/or move up to 25 pounds.

Information Security Compliance: Avita Medical recognizes the importance of information security in ensuring that users have secure access to the information necessary for their work. Avita Medical is committed to safeguarding the security of its information and information systems. Each role within Avita Medical must demonstrate a commitment to information security.