LivaNova · 1 month ago
Manager, AGM Regulatory Affairs
Houston, Texas, United States
Full-time
Hybrid
Mid, Senior Level
$120K/yr - $140K/yrLivaNova is a global medtech company committed to changing lives through innovative healthcare solutions. The Manager, AGM Regulatory Affairs will coordinate and manage regulatory activities for medical devices in the international area, ensuring compliance and effective communication of regulatory strategies.
Health CareMedical DeviceNeuroscience
Responsibilities
Participate on project development teams to ensure that appropriate regulatory strategies are communicated, and regulatory requirements are met
Take care of the preparation and editing of the technical and formal documentation necessary to get registrations and keep them in compliance with product changes with a particular focus on the international Area
Manage premarketing, maintenance and renewal regulatory activities for the manufacturing site in the international Region, in collaboration with the regional regulatory team
Cooperate in the relationships with Vigilance Authorities, Competent Authorities and the National Government Agencies in Europe and in the International Area
Distribute appropriate notifications for product approvals and report on the status of approvals to appropriate company functions
Monitor, verify and review product documentation (Instructions for use, brochures, Company website, etc.) to ensure compliance with relevant law requirements
Interface/correspond with government agencies, industry organizations, distributors, and international personnel to keep abreast of regulatory requirements
Provide necessary/requested information and materials to government agencies, distributors, and international personnel to meet regulatory requirements
Assist if required during facility audits/assessments by government agencies
Keep up to a high level of knowledge and comprehension of laws and regulations impacting on Company products
Qualification
Required
Technical Scientific University master's degree (e.g. Chemistry, Biology, Biotechnology, Pharmacy, etc.)
Several years' experience in the field of Sanitary Regulation; product conformity obtained, at least in part, in Companies in the Pharmaceutical or Medical Device sectors
Knowledge of standards and regulations related to medical devices in EU and US (EUMDR, ISO 13485, 21CFR820) as well as in the international area
Knowledge of the fundamentals of SAMD, digital health or AI regulations
Knowledge of the Windows Office package
Fluent in English (spoken and written)
Ability and experience in preparation of technical and formal documentation necessary for submission and assessment at Notified Bodies and / or Competent Authorities
Preparation of organizational procedures
Attitude to interpersonal relationships, to efficient communication, written and oral; projects management
Preferred
RAPS Society RAC designation is a plus
Knowledge of other languages would be a plus
Benefits
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
Company
LivaNova
LivaNova is a medical technology company that specializes in advanced cardiac surgery, neuromodulation, and circulatory support solutions.
Founded in 1987
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$300M2024-03-05Post Ipo Debt· $300M
2015-10-19IPO
Leadership Team
Vladimir Makatsaria
Chief Executive Officer
Alex Shvartsburg
Chief Financial Officer
Recent News
News-Medical.Net
2026-01-16
2025-12-24
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