Medical Device Regulatory Affairs Strategist

Oracle

Remote Actively hiring
Remote (US) Posted 11 days ago $87,000–$178,100 / year
View original post Log in to save

At a glance

AI generated

TL;DR

As a Principal/Lead/Senior Regulatory Affairs Strategist 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 with evolving regulations across global markets. This role requires expertise in medical device regulations, experience with ISO 13485 and other relevant standards, and the ability to navigate complex legal landscapes while fostering strong partnerships within Oracle’s diverse business units.

Skills

ISO13485 ISO14971 21CFR CEMarking EU_MDR HealthCanadaRegulations 510k TechnicalFiles QualitySystemRegulations RiskManagement ContinualImprovement PostMarketSurveillance InternalAudits ExternalAudits LabelingCompliance MarketingCommunications ClinicalProtocols DesignProcesses ManufacturingProcedures

What you'll do

  • Develop regulatory strategies for AI-enabled software applications used in medical devices and clinical systems.
  • Prepare pre-market submissions such as 510(k), CE Marking under EU MDR, Technical Files, and Health Canada applications.
  • Maintain ongoing documentation and post-market surveillance reports to ensure continuous market authorization compliance.
  • Support internal and external audits to identify and remediate risks and deficiencies in regulatory compliance.
  • Review and recommend changes to labeling, marketing communications, clinical protocols, 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 premarket submissions such as 510(k) and EU Technical Files.
  • Proven ability to interact with notified bodies and regulators effectively.
  • Certification in RAC, CQE, CPPS, or CQA preferred.
  • Experience working within ISO 13485, ISO 14971, 21 CFR parts 1000/1001 quality management systems.
  • Strong understanding of continual improvement and risk management principles.
  • Excellent written and verbal communication skills for dynamic business environments.

Employer

About Oracle

Oracle Corporation is a leading multinational technology company specializing in database software, cloud computing, and enterprise software.

Oracle currently has 343 open roles on FindRole.

Listed pay typically runs $97,500–$199,500 across 253 roles with salary data.

Most-posted roles

View all roles at Oracle