Manager, AGM Regulatory Affairs
About The Position
As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow—because at LivaNova, we don’t just treat conditions — we aspire to alter the course of lives. As the Manager, AGM Regulatory Affairs you coordinate and manage regulatory activities to commercialize the Medical Devices manufactured and distributed by the Company in the International Area.
Requirements
- 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.
Nice To Haves
- RAPS Society RAC designation is a plus
- Knowledge of other languages would be a plus
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
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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
1,001-5,000 employees
