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Lead Regulatory Affairs Specialist
2 months ago
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.