Jobs
>
San Diego

    Senior Regulatory Affairs Specialist - San Diego, United States - Genalyte

    Genalyte
    Genalyte San Diego, United States

    2 weeks ago

    Default job background
    Description

    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 regulatory landscapes, ensuring our groundbreaking products meet all regulatory requirements and reach the market efficiently. If you are passionate about advancing healthcare through cutting-edge technology and thrive in a collaborative environment, we invite you to be a part of our mission to transform diagnostic testing and improve patient outcomes.

    ABOUT THE ROLE
    Senior 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. Responsible for maintaining regulatory related documents.

    WHAT YOU'LL DO

    • Craft, review, and refine technical documents for regulatory submissions, ensuring alignment with applicable guidance.
    • Coordinate and manage Q-submissions for prompt FDA responses.
    • Lead the preparation and submission process for 510(k), PMA, and CE applications.
    • Oversee the e-STAR regulatory submission requirements to meet standards.
    • Maintain comprehensive regulatory files, including 510(k)s, PMAs, Q-Submissions, and CE dossiers for the EU.
    • Develop and manage labels and labeling documents for regulatory submissions.
    • Collaborate with various departments to communicate regulatory requirements and track submission deliverables according to project timelines.
    • Provide strategic regulatory guidance and analysis to support the team.
    • Monitor and ensure the accuracy and currency of regulatory registrations, certifications, and licenses.
    • Stay updated on regulations and guidance documents to ensure ongoing compliance.
    • Support external regulatory agency audits, offering regulatory insights to prevent non-compliance issues.
    • Organize and maintain all regulatory-related documentation meticulously.
    • Adhere to the company's Quality Management System (QMS).
    • Perform additional duties as assigned, contributing to the team's success
    WHAT YOU'LL NEED
    • A minimum of a Bachelor's degree in Science or related discipline of 5-7 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.


    WHY JOIN US
    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: $100,000 - $120,000
    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

    yjgiW5yPYv

  • Cypress HCM

    Regulatory Affairs Specialist

    2 weeks ago

    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 ...

  • Integrated Resources, Inc ( IRI )

    Regulatory Affairs Specialist

    20 hours ago

    Integrated Resources, Inc ( IRI ) San Diego, United States

    Job Title: Regulatory Affairs Specialist · Work Location: San Diego OR San Clemente · Duration: 6 Months · Shift- M-F (8am to 5pm) · Note: · Submission Authoring Experience (510(k) preferred). · EU MDR experience. · Medical Device (MD) Experience (Software as MD or Software in MD ...

  • Cypress Hcm

    Regulatory Affairs Specialist

    1 week ago

    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 ...

  • Astrix Technology

    Regulatory Affairs Specialist

    19 hours ago

    Astrix Technology San Diego, United States

    Regulatory Affairs Specialist - Software · Regulatory Affairs · San Diego, CA, US · Pay Rate Low: 38 | Pay Rate High: 39 · + Added - 21/06/2024 · Apply for Job · Our Client specializes in IV therapy, offering a complete range of systems, software, solutions, and consumables ...

  • JobsRUs

    Regulatory Affairs Specialist

    2 days ago

    JobsRUs San Diego, United States

    Job Description · Job is seeking to hire a Regulatory Affairs Specialist for our client in San Diego, CA · Benefits Available · Weekly Pay · $37.46/Hour · Shift:8a-5p · Description: · Position Summary · Provides regulatory support and expertise by developing global regulatory ...

  • Cypress Human Capital Management, LLC

    Regulatory Affairs Specialist

    1 week ago

    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 ...

  • Aequor Technologies

    Regulatory Affairs Specialist

    8 hours ago

    Aequor Technologies San Diego, United States

    US Regulatory Affairs Lead · SCOPE OF RESPONSIBILITIES: · • He/She will be responsible for representing regulatory function to approve promotional material · • He/She will be at ease working in a matrix environment and be able to navigate ambiguity to drive decision making worki ...

  • Conflux Systems

    Regulatory Affairs Specialist

    2 days ago

    Conflux Systems San Diego, United States

    Job Description · Job DescriptionDescription: · Position Summary · Provides regulatory support and expertise by developing global regulatory strategies, identifying needed registration data, obtaining this data and ensuring that it is effectively presented for the registration of ...

  • Tandem Diabetes

    Regulatory Affairs Specialist II

    1 week ago

    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 ...

  • Invivoscribe

    Senior Regulatory Affairs Specialist

    19 hours ago

    Invivoscribe San Diego, United States

    Job Description · Job Description · Invivoscribe 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 c ...

  • Genalyte

    Senior Regulatory Affairs Specialist

    1 week ago

    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 ...

  • INVIVOSCRIBE INC

    Senior Regulatory Affairs Specialist

    2 weeks ago

    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

    Sr Regulatory Affairs Specialist

    2 weeks ago

    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 ...

  • Tandem

    Regulatory Affairs Specialist II

    5 days ago

    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 ...

  • Philips

    Principal Regulatory Affairs Specialist, Software

    1 week ago

    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 ...

  • Customs And Border Protection

    Public Affairs Specialist

    1 month ago

    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 ...

  • BD

    Staff Regulatory Affairs Specialist, Infusion

    2 weeks ago

    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)

    Staff Regulatory Affairs Specialist, Infusion

    3 weeks ago

    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

    Marketing & Communications Specialist (Public Affairs/Communications Specialist III)

    3 weeks ago

    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 ...

  • BD (Becton, Dickinson and Company)

    Staff Regulatory Affairs Specialist, Infusion

    2 weeks ago

    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 ...