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Lead Regulatory Affairs Specialist

2 months ago


Honolulu, Hawaii, United States Oracle Full time
Job Summary

We are seeking an experienced Regulatory Compliance Specialist to join our team at Oracle.

Key Responsibilities:

  • Assist in ensuring compliance with government regulations and/or regulatory agencies.
  • Support the organization in complying with regulatory requirements.
  • Develop regulatory strategies and roadmaps for Medical Device programs.
  • Train stakeholders on current and new regulatory requirements.
  • Serve as an intermediary between the organization and regulatory authorities.
  • Identify regulatory risks and propose mitigations.
  • Support and engage with team members to ensure regulatory compliance.

Day-to-Day Responsibilities:

  • Collaborate with Development organizations to create and manage pre-market submissions.
  • Evaluate the regulatory environment and provide internal advice.
  • Maintain documentation and post-market surveillance reporting.
  • Collaborate with fellow members of the Regulatory Affairs team.

Requirements:

  • 8-10+ years of relevant experience.
  • BA/BS or advanced degree.
  • Regulatory Affairs Certification or CQE preferred.
  • Excellent written and verbal communication and presentation skills.
  • Experience in working within a quality management system.
  • Understanding of continual improvement and risk management.
  • Ability to balance multiple projects/deliverables.
  • Project Management Skills.

Benefits:

  • Comprehensive benefits package.
  • Medical, dental, and vision insurance.
  • Short term disability and long term disability.
  • Life insurance and AD&D.
  • Health care and dependent care Flexible Spending Accounts.
  • Pre-tax commuter and parking benefits.
  • 401(k) Savings and Investment Plan with company match.
  • Paid time off.
  • 11 paid holidays.
  • Paid sick leave.
  • Paid parental leave.
  • Adoption assistance.
  • Employee Stock Purchase Plan.
  • Financial planning and group legal.
  • Voluntary benefits.