Regulatory Affairs Specialist

New

United StatesFull-TimeMiddle

Salary not disclosed

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Job Details

Bachelor’s degree in Computer Science, Life Sciences, or a related field.
Minimum of 3 years of regulatory affairs experience within a regulated life sciences or healthcare environment in the United States.
Strong knowledge of medical device regulations.
Strong knowledge of Software as a Medical Device (SaMD) regulations.
Experience with histopathology laboratory accreditation standards such as CAP, CLIA, and ISO 15189:2022.
Familiarity with digital pathology systems and imaging technologies is highly advantageous.
Exposure to AI technologies, emerging regulatory frameworks, and data privacy/security standards is a plus.
Understanding of healthcare compliance topics such as billing practices and regulatory risk frameworks is an advantage.
Strong analytical, communication, and stakeholder management skills.
Ability to work in cross-functional global teams.

Develop and execute regulatory strategies for digital pathology products and AI-enabled healthcare solutions across North America and other regions.
Prepare, compile, and submit regulatory filings and accreditation applications to agencies such as FDA, CMS-CLIA-LDT, CAP, SCC, and other global authorities.
Maintain ongoing compliance through post-market surveillance activities, regulatory reporting, and monitoring of evolving requirements.
Lead engagement with regulatory bodies, notified entities, and competent authorities to support approvals, audits, inspections, and ongoing regulatory communications.
Establish and maintain global regulatory databases, policies, and procedures.
Support quality systems integration by embedding regulatory requirements into change control, complaint handling, training, document management, and internal audits.

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