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Regulatory Operations Specialist

2 months ago

Houston, Texas, United States LivaNova, PLC Full time
Job Summary

We are seeking a highly skilled Regulatory Operations Specialist to join our team at LivaNova, PLC. This role will be responsible for supporting global regulatory operations and fast impact projects.

Key Responsibilities
  • Administer global processes for monitoring, controlling, and communicating external documents applicable to LivaNova medical devices.
  • Manage and provide leadership to cross-functional teams to develop and execute sustaining, continuous improvement regulatory compliance projects.
  • Responsible for generating and updating data and metrics used to update senior management on a periodic basis.
  • Identify procedures and best practices for control of external documents and drive efforts for continuous improvement.
  • Develop detailed plans in alignment with strategic objectives of the program, including master schedules, budgets, program milestones, and key program tasks and deliverables.
  • Provide guidance and direction to core team as necessary to define clear goals and evaluate progress.
  • Resolve program resource issues and facilitate reallocation of activities and efforts to ensure schedules are achieved.
  • Comply with US FDA regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Requirements
  • Bachelor's degree in engineering or science.
  • Resourceful, creative, well-organized with an ability to prioritize and proactively offer solutions.
  • Ability to work effectively within a team in a fast-paced changing environment.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Excellent verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Prioritizes and meets deadlines in a timely manner.
  • Proficient in MS Office tools (Outlook, PowerPoint, Word, and Excel).
Preferred Qualifications
  • BS degree in related Engineering discipline.
  • Knowledge and understanding of medical device related standards used medical device quality systems, and in the design, development, and distribution of medical devices.
  • Significant experience working in a broader enterprise/cross functional business preferred.
  • Experience with project management tools such as MS Project.
  • Experience in regulatory affairs.
  • Experience in standards development.
  • Strong research and organizational skills.
What We Offer
  • Target Compensation Range: $100,000 - $130,000 per year plus annual bonus.
  • Health benefits - Medical, Dental, Vision.
  • Personal and Vacation Time.
  • Retirement & Savings Plan (401K).
  • Employee Stock Purchase Plan.
  • Training & Education Assistance.
  • Bonus Referral Program.
  • Service Awards.
  • Employee Recognition Program.
  • Flexible Work Schedules.
Our Commitment to Diversity & Inclusion

LivaNova values equality and celebrates diversity. We are committed to ensuring that our recruitment process is fair, transparent, and free from unlawful discrimination.