Quality Assurance Regulatory Affairs Manager

3 hours ago

Tel Aviv, Tel Aviv, Israel MedHub-AI Full time ₪90,000 - ₪120,000 per year

QA/RA Manager – MedHub-AI

Location:
Tel Aviv, Israel

MedHub-AI is transforming cardiology through cutting-edge AI technology. We are looking for an experienced
QA/RA Manager
to lead regulatory and quality processes, ensuring compliance and successful approvals across multiple global markets.

Responsibilities:

  • Manage regulatory submissions and approvals for
    FDA (510(k) & De Novo), CE, AMAR (Israel), China, Canada, and Singapore
    .
  • Oversee the transition from
    MDD to MDR
    , working with
    notified bodies
    and
    external regulatory affairs agencies
    .
  • Maintain
    ISO 13485 certification
    and ensure QMS compliance.
  • Develop, review, and execute
    clinical study protocols
    , working with
    external CRAs
    and
    site study coordinators
    .
  • Lead interactions with
    regulatory bodies
    , including
    FDA pre-sub meetings and IRB processes
    .
  • Ensure regulatory compliance for
    Software as a Medical Device (SaMD)
    products.
  • Drive regulatory timelines, ensuring approvals are met within deadlines.

Requirements:

  • At least
    7 years
    of experience in regulatory affairs for medical devices, securing approvals in multiple regions.
  • Hands-on experience in
    clinical studies
    , working with
    external CRAs
    , and conducting CRA activities directly.
  • Direct experience with
    FDA pre-sub meetings, IRB approvals, and clinical protocol development
    .
  • Strong background in
    ISO 13485, QMS maintenance, and certification processes
    .
  • Experience working with
    notified bodies
    and regulatory agencies.
  • Ability to push regulatory projects forward and meet strict deadlines.
  • Relevant academic background
    in
    biomedical engineering, regulatory affairs, life sciences, or a related field
    .
  • Professional-level English proficiency
    (native or equivalent).

Preferred Experience:

  • Regulatory experience in
    cardiology
    and
    high-risk medical devices
    .
  • Strong understanding of
    Software as a Medical Device (SaMD)
    compliance.

MedHub-AI offers an opportunity to work on innovative healthcare solutions, ensuring they meet the highest regulatory standards. If you have the expertise and drive to lead our QA/RA efforts, we encourage you to apply.

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