Jobs
>
San Francisco

    Vice President Regulatory Affairs - San Francisco, United States - Barrington James

    Barrington James
    Barrington James San Francisco, United States

    1 week ago

    Default job background
    Description
    Direct message the job poster from Barrington James
    Regulatory Affairs and Quality Assurance (Medical Devices)

    Vice President Regulatory Affairs (Medical Device) - ONSITE in Bay Area
    Our esteemed client, a inovative and growing medical device company specializing in the manufacturing of implantable medical devices.

    They are looking for a Vice President Regulatory Affairs to spearhead regulatory strategies that will shape the future of healthcare and continue building out their Regulatory Department.


    Key Responsibilities:


    Develop and implement global regulatory strategies for the successful approval and commercialization of implantable devices in the US and international markets.

    Oversee the preparation and submission of regulatory dossiers for FDA and OUS regulatory approvals, including IDE, 510(k), PMA, and CE Mark applications.

    Act as the primary point of contact with regulatory authorities, ensuring open communication and successful interactions during the review process.

    Collaborate cross-functionally with R&D, Quality Assurance, Clinical Affairs, and other departments to align regulatory objectives with business goals.

    Stay abreast of evolving regulatory requirements and industry trends, providing guidance to the executive team and ensuring the company's ongoing compliance with global regulations.

    Experience with implantable devices and Software experience/Cybersecurity would be a plus.
    Build and develop a proactive, versatile and cross functional regulatory team.

    Qualifications:
    A minimum of 12 years of experience in regulatory affairs within the medical device industry.

    Proven track record of successful regulatory submissions and approvals in both the US (510k, De Novo, PMA) and international markets (CE Mark and OUS submissions).

    Strong leadership and management skills, with experience leading regulatory teams and driving results in a fast-paced environment.
    Deep knowledge of the full product lifecycle for Medical Devices.
    In-depth knowledge of global medical device regulations, standards, and guidelines, and the ability to interpret and apply them effectively.
    Excellent communication and interpersonal skills, with the ability to build relationships with regulatory authorities and cross-functional teams.
    A bachelor's degree in a related field (Engineering); an advanced degree is preferred.
    If you would like to learn more about this Vice President Regulatory Affairs opportunity and have the desire to build and develop a regulatory team, apply today or contact me directly on the following:
    Seniority level

    Seniority level

    Executive
    Employment type

    Employment type

    Full-time
    Job function

    Job function

    Science and Strategy/Planning
    Industries

    Medical Equipment Manufacturing
    Referrals increase your chances of interviewing at Barrington James by 2x
    Get notified about new

    Vice President Regulatory Affairs

    jobs in

    San Francisco Bay Area .
    San Francisco Bay Area

    $200,000 - $300,000

    3 weeks ago
    Daly City, CA

    $230,000 - $250,000

    3 weeks ago
    San Francisco, CA

    $252,000 - $350,000

    2 months ago
    Mountain View, CA

    $150,000 - $235,000

    3 days ago
    VP, Associate General Counsel, Corporate Legal

    San Jose, CA

    $229,400 - $471,500

    1 month ago
    Vice President, Head of Regulatory Affairs

    Emeryville, CA

    $305,000 - $365,000

    2 months ago
    San Francisco Bay Area

    $300,000 - $350,000

    2 weeks ago
    Senior Corporate Counsel / Director of Legal

    San Jose, CA

    $161,000 - $200,000

    1 month ago
    Menlo Park, CA

    $252,000 - $300,000

    1 month ago
    Legal Managing Director - Stealth Start Up Technology Company

    We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

    #J-18808-Ljbffr
  • Synergy Solutions

    Regulatory Affairs Specialist

    2 weeks ago

    Synergy Solutions Hercules, United States

    Essential Onsite · - no hybrid. M-F 8:00 to 4:30 however we are flexible. · *Less than 1 year experience in IVD medical device industry is acceptable* · - Provide regulatory support for IVD products with multiple product groups within clinical diagnostics. · - Work with regulator ...

  • BioLink 360

    Regulatory Affairs Director

    1 week ago

    BioLink 360 San Francisco, United States

    Company Location: · Bay Area · Comp: · 150K-220K · Position Reports to: · VP of Regulatory and Quality · Director of Regulatory Affairs -San Francisco · We are seeking a highly motivated and experienced Senior Director of Regulatory Affairs for a Medical Device Orthopedic Port ...

  • Cytokinetics

    Associate Director, Regulatory Affairs

    1 week ago

    Cytokinetics South San Francisco, United States

    Reporting to the Senior Director, Regulatory Affairs, the Associate Director of Regulatory Affairs leads regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international development strategies. · **Responsibilities** ...

  • Knewin

    Specialist, Regulatory Affairs

    1 week ago

    Knewin San Francisco, United States

    About Pendulum · Pendulum is on a mission to help people improve physical and mental health by creating a new category of products that target the microbiome. We are researching, developing and commercializing a novel class of rationally-designed Live Synbiotics (probiotics + pr ...

  • Katalyst Healthcares and Life Sciences

    Regulatory Affairs Specialist

    3 weeks ago

    Katalyst Healthcares and Life Sciences San Francisco, United States Full time

    Responsibilities: · Develop global regulatory strategies for medical device products to meet business objectives and collaborates across a matrixed organization to ensure global success of products\' registration. · Participate on product development teams, providing regulatory s ...

  • Hinge Health

    Regulatory Affairs Manager

    1 day ago

    Hinge Health San Francisco, United States Regular Full time

    Hinge Health is moving people beyond pain by transforming the way it is treated and prevented. Connecting people digitally and in-person with expert clinical care, we combine advanced technology, AI and a care team of experts to guide people through personalized care directly fro ...

  • Infosoft

    Regulatory Affairs Specialist-4694

    6 days ago

    Infosoft Palo Alto, United States

    One of our clients is looking for a talented and highly motivated **Sr. Regulatory Affairs Specialist**. Please **send your resume** if you would like to pursue this opportunity and you authorize Infosoft to represent you for this position. · Here are the job position details for ...

  • Meet Recruitment

    AD/Director Regulatory Affairs

    1 week ago

    Meet Recruitment San Francisco, United States

    Meets clinical-stage biopharmaceutical client based in the Bay Area is seeking a highly motivated individual to join their growing regulatory affairs group. The Associate Director / Director, Regulatory Affairs will work closely with the Regulatory Affairs team and other departme ...

  • Ascendis Pharma

    Head of Regulatory Affairs, Oncology

    1 week ago

    Ascendis Pharma Palo Alto, United States

    HybridPalo Alto, California, United StatesOncology, Regulatory, OncologyFull time1404 · Description · We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we're advancing programs in Endocrinology Rare Disease, and Oncol ...

  • Meet Recruitment

    Senior Director Regulatory Affairs

    6 days ago

    Meet Recruitment San Francisco, United States

    This range is provided by Meet. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. · Job Title: · Senior Director of Regulatory Affairs (Oncology Focus) · About Us: · We are parntered with a dynamic and innovative biotechnology ...

  • Meet

    Senior Director Regulatory Affairs

    1 week ago

    Meet San Francisco, United States

    This range is provided by Meet. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. · Job Title: · Senior Director of Regulatory Affairs (Oncology Focus) · About Us: · We are parntered with a dynamic and innovative biotechnology ...

  • SciPro

    Senior Director Regulatory Affairs

    1 week ago

    SciPro San Francisco, United States

    Senior Director, Regulatory Affairs · San Francisco, CA (Hybrid) · Join this Bioscience company on the forefront of groundbreaking therapeutics I'm supporting a company seeking a dynamic individual for the role of Sr. Director, Regulatory Affairs. This pivotal position offers the ...

  • Dennis Partners

    Vice President of Regulatory Affairs

    1 week ago

    Dennis Partners San Francisco, United States

    This clinical-stage biotech company is revolutionizing the treatment of cancer. They are seeking a Vice President of Regulatory Affairs to oversee all regulatory activities including serving as the primary contact with FDA and other regulatory agencies. You will develop and imple ...

  • Dennis Partners

    Regulatory Affairs Vice President

    2 weeks ago

    Dennis Partners San Francisco, CA, United States

    This clinical-stage biotech company is revolutionizing the treatment of cancer. They are seeking a Vice President of Regulatory Affairs to oversee all regulatory activities including serving as the primary contact with FDA and other regulatory agencies. You will develop and imple ...

  • Alga Biosciences

    Governmental and Regulatory Affairs Lead

    1 week ago

    Alga Biosciences San Francisco, United States

    [Full Time] Governmental and Regulatory Affairs Lead at Alga Biosciences (United States) | BEAMSTART Jobs · Governmental and Regulatory Affairs Lead · Alga Biosciences United States · Date Posted · 31 Oct, 2022 · Work Location · San Francisco, United States · Salary Offered · $ ...

  • Nusano

    Vice President of Regulatory Affairs

    2 weeks ago

    Nusano West Valley City, United States

    Overview · Position Summary: · Nusano is seeking a dynamic and highly skilled Vice President of Regulatory Affairs & Quality Assurance to lead and oversee the regulatory and quality assurance functions at Nusano's state of-the-art facility in West Valley City, Utah. This role re ...

  • Scipro

    Senior Director Regulatory Affairs

    3 weeks ago

    Scipro San Francisco, CA, United States

    Senior Director, Regulatory Affairs · San Francisco, CA (Hybrid) · Join this Bioscience company on the forefront of groundbreaking therapeutics I'm supporting a company seeking a dynamic individual for the role of Sr. Director, Regulatory Affairs. This pivotal position offers th ...

  • Life Science People

    Senior Director Regulatory Affairs

    1 week ago

    Life Science People San Francisco, United States

    This range is provided by Life Science People. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. · Base pay range · $250,000.00/yr - $300,000.00/yr · Direct message the job poster from Life Science People · Provide regulatory g ...

  • Alga Biosciences

    Remote Regulatory Affairs Lead

    3 weeks ago

    Alga Biosciences San Francisco, CA, United States

    Full Time] Governmental and Regulatory Affairs Lead at Alga Biosciences (United States) | BEAMSTART Jobs Governmental and Regulatory Affairs Lead · Full Time · Remote Work · Stock Options · Alga Biosciences is a fast-moving startup on a mission to transform the agricultural i ...

  • Abdera Therapeutics

    Senior Regulatory Affairs Director

    2 weeks ago

    Abdera Therapeutics San Francisco, CA, United States

    Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the deliv ...