Medical Device Regulatory Affairs Strategist

Oracle

Remote Actively hiring
Remote (US) Posted 10 days ago $87,000–$178,100 / year
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At a glance

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TL;DR

As a Principal/Lead/Senior Regulatory Affairs Specialist at Oracle’s Health & Life Sciences Legal and Compliance Group, you will collaborate with product engineering teams to develop regulatory strategies for AI-enabled software applications used in clinical operations and decision support systems. Your responsibilities include preparing documentation for global market registration, managing pre-market submissions such as 510(k) and CE Marking under EU MDR, and ensuring ongoing compliance through post-market surveillance reports. You will also serve as a subject matter expert on regulatory standards and quality management systems, supporting internal audits and recommending changes to maintain compliance across various markets. This role requires expertise in medical device regulations, experience with ISO 13485 and other relevant standards, and the ability to navigate complex global regulatory landscapes efficiently.

Skills

ISO 13485 14971 21 CFR CE Marking EU MDR Health Canada Submissions 510(k) Quality Management System Risk Management Regulatory Affairs Post-Market Surveillance Internal Audits Labeling Compliance Marketing Communications Clinical Protocols Manufacturing Procedures SA MD

What you'll do

  • Develop regulatory strategies for AI-enabled software applications used in medical devices and clinical systems.
  • Create and manage pre-market submissions to ensure compliance with global regulatory authorities.
  • Maintain documentation and post-market surveillance reports to uphold market authorization.
  • Support internal audits and address risks and deficiencies related to regulatory compliance.
  • Review and recommend changes to labeling, marketing communications, and manufacturing procedures for regulatory adherence.

What we're looking for

  • 10+ years of experience in medical device Regulatory Affairs, Quality Compliance, or Product Development
  • Extensive experience authoring regulatory submissions (510(k), EU Tech Files)
  • Experience working with notified bodies and regulators
  • Knowledge of ISO 13485, ISO 14971, 60601, and FDA Quality System Regulations
  • Strong understanding of continual improvement and risk management principles
  • Excellent written and verbal communication skills for dynamic environments

Employer

About Oracle

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