Jobs
>
San Diego

    Regulatory Affairs Specialist - San Diego, United States - Genalyte

    Genalyte
    Genalyte San Diego, United States

    4 weeks ago

    Show more Collapse job
    Default job background
    Description

    Here at Genalyte, you will find yourself working with talented individuals inspired by our vision, eager to make an impact on the patient experience, and who share a common goal of getting our technology into every physician's office. We have a great opportunity for a Regulatory Affairs Specialist to join our team

    ABOUT THE ROLE

    The Regulatory Affairs Specialist will assist in regulatory submissions, interpret regulations, and provide regulatory guidance. This role will be responsible for preparing submission documents and work cross-functionally with other departments to ensure timely completion of deliverables related to regulatory submissions. This role will also be responsible for maintaining regulatory related documents.

    ESSENTIAL FUNCTIONS & RESPONSIBILITIES

    These may include but are not limited to:

    • Write, review, and edit technical documents for regulatory submissions in a format consistent with applicable guidance documents
    • Prepare and manage Q-submissions for timely responses from the FDA
    • Assist in regulatory submissions (510(k), PMA, and CE)
    • Prepare and manage e-STAR regulatory submission requirements
    • Maintain regulatory files such as 510(k)s, PMAs, Q-Submissions, and CE dossiers for EU
    • Support preparation of labels and labeling documents for submissions
    • Work with other departments and communicate regulatory submission requirements and track submission deliverables for completion as per the project timelines
    • Provide support to the team with regulatory strategy analyses and options
    • Monitor and maintain regulatory registrations, certifications and licenses, ensuring they are accurate and up-to-date
    • Keep abreast of regulations / guidances to ensure compliance
    • Support external regulatory agency audits, providing regulatory input to minimize or prevent potential findings of non-compliance
    • Organize and maintain all regulatory related documents
    • Comply with company's QMS
    • Other duties as assigned

    EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

    • A minimum of a Bachelor's degree in Science or related discipline of 4 - 5 years experience in IVD regulatory or similar
    • Certification in regulatory affairs is a bonus
    • Excellent understanding of regulations and strong analytical and problem-solving skills
    • Excellent written and Verbal communication skills with the ability to listen, articulate and advocate
    • Strong prioritization skills, flexibility and ability to handle multiple projects simultaneously while meeting deadlines
    • Ability to communicate effectively with employees across multiple departments
    • Proficient in Microsoft Office applications - MS Word, Excel, and Powerpoint
    • Strong organizational skills and attention to detail, along with the ability to work on a number of projects with tight timelines

    BENEFITS & STOCK OPTIONS

    At Genalyte, we believe in investing in our employees' well-being and success. As a valued member of our team, you'll have access to a comprehensive benefits package, including competitive salary, health, dental, and vision insurance, and flexible paid time off. Additionally, we offer stock ownership and equity participation, providing you with the opportunity to directly share in the success and growth of the company. Join us in shaping the future of healthcare while building a rewarding career.

    SALARY RANGE: $75,000 - $100,000

    Offer decisions and base salary depend on a variety of factors including, but not limited to, an individual's skills, qualifications, business need and experience.

    Powered by JazzHR


    We have other current jobs related to this field that you can find below


  • Cypress HCM San Diego, United States

    Regulatory Affairs Specialist · The Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clini ...


  • Cypress Hcm San Diego, United States

    Regulatory Affairs Specialist · The Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clinic ...


  • Cypress Human Capital Management, LLC San Diego, United States

    Regulatory Affairs Specialist · The Regulatory Affairs Specialist IV will coordinate the accumulation of technical information and prepare submissions for in vitro diagnostic and medical device licenses to various governmental regulatory agencies. They will also coordinate clinic ...


  • Tandem Diabetes San Diego, United States

    Supports Regulatory post-market sustaining and operations management for medical device hardware, software, and accessories. Responsible for ensuring medical device compliance with all global applicable regulations for regulatory projects to meet cor Regulatory Affairs, Regulator ...


  • Genalyte San Diego, United States

    Job Description · Job Description Genalyte, Inc., a leader in innovative diagnostic solutions, is seeking a highly skilled and motivated Senior Regulatory Affairs Specialist to join our dynamic team. In this pivotal role, you will leverage your expertise to navigate complex regul ...


  • INVIVOSCRIBE INC San Diego, United States

    Job Description · Job DescriptionInvivoscribe is an industry pioneer, dedicated to Improving Lives with Precision Diagnostics. Invivoscribe has been the global leader in driving international standardization of testing and accelerating patient access to the newest and best cancer ...


  • Dexcom San Diego, United States

    About Dexcom · Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transformi ...


  • Genalyte San Diego, United States

    Genalyte, Inc., a leader in innovative diagnostic solutions, is seeking a highly skilled and motivated Senior Regulatory Affairs Specialist to join our dynamic team. In this pivotal role, you will leverage your expertise to navigate complex regulatory landscapes, ensuring our gro ...


  • Tandem San Diego, United States

    GROW WITH US: · Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We'd love for you to team up with us to "innovate every day," put "people first," and take ...


  • Customs And Border Protection San Diego, United States Full time

    You will participate in policy-making meetings and conferences, serving as an advisor on issues related to identifying information that will further the Agency's mission and goals. You will also maintain working relationships with representatives of the media; Federal, state, and ...


  • Philips San Diego, United States

    Principal Regulatory Affairs Specialist, Software (U.S. Hub based) · Clinical Integration and Insight (CII) is changing the way healthcare is delivered at the point of care. Our Capsule Surveillance product is a clinical decision support software medical device (SaMD) that uses p ...


  • BD San Diego, United States

    Job Description Summary · As Staff Regulatory Affairs Specialist, Infusion, you will be responsible for Regulatory Affairs projects within the Medication Management Systems Infusion portfolio. Regulatory Affairs activities, will include: development, execution and management of ...


  • BD (Becton, Dickinson and Company) San Diego, United States

    **Job Description Summary** · As Staff Regulatory Affairs Specialist, Infusion, you will be responsible for Regulatory Affairs projects within the Medication Management Systems Infusion portfolio. Regulatory Affairs activities, will include: development, execution and management ...


  • BD (Becton, Dickinson and Company) San Diego, United States

    **Job Description Summary** · As Staff Regulatory Affairs Specialist, Infusion, you will be responsible for Regulatory Affairs projects within the Medication Management Systems Infusion portfolio. Regulatory Affairs activities, will include: development, execution and management ...


  • San Diego State University San Diego, United States

    Position Summary · Under the direction of the Associate Director for Communications and Strategic Initiatives, the Marketing and Communications (MarCom) Specialist manages all marketing and communications activities for the Office of Housing Administration (OHA), including graph ...


  • Philips San Diego, United States Full time

    Job Title · Regulatory Affairs SpecialistJob Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and faire ...


  • Philips San Diego, United States

    Job Title · Principal Regulatory Affairs Specialist-Coronary Vascular · Job Description · The Principal Regulatory Affairs Specialist will play a critical role in ensuring Philips Image-Guided Therapy Devices (IGTD) Coronary Vascular (CV) products are safe, effective, and comp ...


  • Philips North America San Diego, United States

    Job TitlePrincipal Regulatory Affairs Specialist-Coronary Vascular · Job Description The Principal Regulatory Affairs Specialist will play a critical role in ensuring Philips Image-Guided Therapy Devices (IGTD) Coronary Vascular (CV) products are safe, effective, and compliant w ...


  • Philips San Diego, United States Full time

    Job Title · Principal Regulatory Affairs Specialist-Coronary VascularJob Description · The Principal Regulatory Affairs Specialist will play a critical role in ensuring Philips Image-Guided Therapy Devices (IGTD) Coronary Vascular (CV) products are safe, effective, and compliant ...


  • Philips San Diego, United States

    The Senior RA Specialist will play a critical role in ensuring Philips Computed Tomography (CT) and Advanced Molecular Imaging (AMI) solutions are safe, reliable, and compliant through driving global regulatory strategy and regulatory roadmaps—understanding competitive claim land ...