Jobs

    Sr. Specialist, Regulatory Affairs - Carlsbad, United States - Alphatec Spine

    Alphatec Spine
    Alphatec Spine Carlsbad, United States

    3 weeks ago

    Default job background
    Technology / Internet
    Description
    The Senior Regulatory Affairs Specialist will be responsible for the development of submissions for domestic and international clearances; as well as the support of daily activities related to new product development, change control, and regulatory product submissions.

    Essential Duties And Responsibilities

    • Collaborates as a core team member on new product development teams. Independently determines and documents appropriate regulatory strategy for proposed new products. Supports design control activities. Provides regulatory input to project timeline planning
    • Prepares regulatory submissions including 510(k) premarket notifications for US FDA
    • Prepares regulatory submissions including technical files/design dossiers for registration of products in MDSAP countries and interfaces as needed with Notified Bodies regarding significant changes to products
    • Responsible for internal process improvements, data/metric evaluation, maintenance of databases, and public-facing information
    • Critically reviews verification and validation reports, and other documents for scientific merit and to ensure adherence to regulatory requirements
    • Assists with post market surveillance evaluation, trending, and reporting including updates to risk management (e.g., FMEA) process
    • Reviews product labeling and promotional materials to ensure consistency with regulatory approvals/clearances
    • Reviews nonconformances and deviations and provides regulatory guidance and expertise.
    • Provides mentorship to less senior regulatory team members.
    • Researches sources of regulatory information (e.g., regulatory agency websites, standards organization websites, literature, trade sheets, competitor information, etc.)
    • Provides department support during internal and external audits
    • Assists in developing, maintaining, assigning, and tracking company Standard Operating Procedures (SOPs) to ensure compliance with applicable global regulatory requirements
    • Maintains FDA establishment listings and registration
    • Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including FDA regulations, 510(k)s, labeling and promotional materials, 21 CFR 820, 21 CFR 1271, global medical device registration, technical writing, and external standards
    • Other duties as assigned

    Requirements

    The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
    • Typically requires a bachelor's degree in a STEM field and five years of experience in regulatory affairs in the medical device industry
    • Strong knowledge of FDA Quality System Requirements (QSR), ISO 13485, ISO 14971
    • Orthopedic or spine experience preferred
    • RAC certification preferred
    • Must have 510(k) submission experience
    • Must be detail oriented and possess strong technical writing skills
    • Must have the ability to think critically and strategically
    • Must possess strong interpersonal communication, teamwork and organizational skills

    Education And Experience

    • Minimum 4 Year / Bachelor's Degree in a STEM Field
    • 5+ Years in an FDA-regulated environment

    For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).

    ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.

    Salary Range

    Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate's qualifications, education, skill set, years of experience, and internal equity. $110,000 to $145,000 Full-Time Annual Salary
  • Internetwork Expert Inc

    Regulatory Affairs Specialist

    3 weeks ago

    Internetwork Expert Inc Carlsbad, United States

    ATEC Spine has an exciting opportunity for a Regulatory Affairs Specialist to work on-site at our location in San Diego, California. The Regulatory Affairs Specialist will support the development of submissions for domestic and international clearances for spine surgery products; ...

  • Alphatec Spine

    Sr. Specialist, Regulatory Affairs

    3 weeks ago

    Alphatec Spine Carlsbad, United States

    The Regulatory Affairs Senior Specialist will be responsible for providing regulatory support of spinal implant and instrument product launches for domestic and international countries; as well as the support of daily activities related to product design teams, design control, an ...

  • Atec Spine

    Sr. Specialist, Regulatory Affairs

    11 hours ago

    Atec Spine Carlsbad, United States

    The Senior Regulatory Affairs Specialist will be responsible for the development of submissions for domestic and international clearances; as well as the support of daily activities related to new product development, change control, and regulatory product submissions.Essential D ...

  • Atec Spine

    Sr. Specialist, Regulatory Affairs

    3 weeks ago

    Atec Spine Carlsbad, United States

    The Regulatory Affairs Senior Specialist will be responsible for providing regulatory support of spinal implant and instrument product launches for domestic and international countries; as well as the support of daily activities related to product design teams, design control, an ...

  • Alphatec Spine

    Regulatory Affairs Specialist

    3 weeks ago

    Alphatec Spine Carlsbad, United States

    ATEC Spine has an exciting opportunity for a Regulatory Affairs Specialist to work on-site at our location in San Diego, California. The Regulatory Affairs Specialist will support the development of submissions for domestic and international clearances for spine surgery products; ...

  • Internetwork Expert Inc

    Regulatory Affairs Specialist

    2 weeks ago

    Internetwork Expert Inc Carlsbad, United States

    ATEC Spine has an exciting opportunity for a Regulatory Affairs Specialist to work on-site at our location in San Diego, California. The Regulatory Affairs Specialist will support the development of submissions for domestic and international clearances for spine surgery products; ...

  • Alphatec Spine

    Regulatory Affairs Specialist

    3 weeks ago

    Alphatec Spine Carlsbad, United States

    Primary responsibilities include the development of submissions for domestic and international clearances. Additionally, will assist to support daily activities such as new product development, change control, and post market surveillance. · Essential Duties And Responsibilities ...

  • Alphatec Spine

    Regulatory Affairs Specialist

    1 week ago

    Alphatec Spine Carlsbad, United States

    Primary responsibilities include the development of submissions for domestic and international clearances. Additionally, will assist to support daily activities such as new product development, change control, and post market surveillance. · Essential Duties And Responsibilities ...

  • Alphatec Spine

    Regulatory Affairs Specialist

    2 weeks ago

    Alphatec Spine Carlsbad, United States

    Job Description · Job DescriptionPrimary responsibilities include the development of submissions for domestic and international clearances. Additionally, will assist to support daily activities such as new product development, change control, and post market surveillance. · Essen ...

  • Atec Spine

    Sr. Specialist, Regulatory Affairs

    3 weeks ago

    Atec Spine Carlsbad, United States

    The Regulatory Affairs Senior Specialist will be responsible for providing regulatory support of spinal implant and instrument product launches for domestic and international countries; as well as the support of daily activities related to product design teams, design control, an ...

  • Internetwork Expert Inc

    Sr. Specialist, Regulatory Affairs

    3 weeks ago

    Internetwork Expert Inc Carlsbad, United States

    The Regulatory Affairs Senior Specialist will be responsible for providing regulatory support of spinal implant and instrument product launches for domestic and international countries; as well as the support of daily activities related to product design teams, design control, an ...

  • Alphatec Spine

    Sr. Specialist, Regulatory Affairs

    2 weeks ago

    Alphatec Spine Carlsbad, United States

    Job Description · Job DescriptionThe Senior Regulatory Affairs Specialist will be responsible for the development of submissions for domestic and international clearances; as well as the support of daily activities related to new product development, change control, and regulator ...

  • Internetwork Expert Inc

    Sr. Specialist, Regulatory Affairs

    3 weeks ago

    Internetwork Expert Inc Carlsbad, United States

    The Regulatory Affairs Senior Specialist will be responsible for providing regulatory support of spinal implant and instrument product launches for domestic and international countries; as well as the support of daily activities related to product design teams, design control, an ...

  • Atec Spine

    Sr. Specialist, Regulatory Affairs

    2 weeks ago

    Atec Spine Carlsbad, United States

    The Senior Regulatory Affairs Specialist will be responsible for the development of submissions for domestic and international clearances; as well as the support of daily activities related to new product development, change control, and regulatory product submissions. · Essenti ...

  • Clearway Energy Group

    Manager, Regulatory and Market Policy West

    1 week ago

    Clearway Energy Group Carlsbad, United States

    **What The Role Is**: · The Manager, Regulatory and Market Policy will represent Clearway's interests in the dynamic, complex, and rapidly evolving landscape of regional markets and state regulatory policy in the Western United States. This role will support the ongoing growth an ...

  • Clearway Energy

    Manager, Regulatory and Market Policy West

    1 week ago

    Clearway Energy Carlsbad, United States

    **What The Role Is**: · The Manager, Regulatory and Market Policy will represent Clearway's interests in the dynamic, complex, and rapidly evolving landscape of regional markets and state regulatory policy in the Western United States. This role will support the ongoing growth an ...

  • Orthofix

    Vice President, Deputy General Counsel

    2 days ago

    Orthofix Carlsbad, United States

    Why Orthofix? · We are a leading global spine and orthopedics company with a premier portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. Our combined company is over 1,600 strong, wi ...

  • Jazz Pharmaceuticals

    Manager, Medical Affairs, GIME Grants

    2 weeks ago

    Jazz Pharmaceuticals Carlsbad, United States Full time

    Brief Description: · The Manager of Global Medical Affairs, Independent Medical Education (IME) Grants will be responsible for the successful development and management of the global medical education grant program for assigned therapeutic areas (Tas). The position will support ...

  • Jazz Pharmaceuticals

    Senior Principal Statistician, Biostatistics

    3 weeks ago

    Jazz Pharmaceuticals Carlsbad, United States Full time

    Brief Description: · The Senior Principal Statistician, Biostatistics will be a lead statistician on individual studies, across related studies, and for integrated summaries and will design and report Phase I to IV clinical studies and regulatory filings under the supervision of ...

  • Alphatec Spine

    Director of Clinical Research

    4 weeks ago

    Alphatec Spine Carlsbad, United States

    ATEC Spine has an exciting opportunity for a Director of Clinical Research & Strategy as a member of the Scientific Affairs team located in Carlsbad, California. ATEC's Scientific Affairs team is responsible for regulatory, testing, and research activities in support of the compa ...