Regulatory Affairs Manager

LivaNova

Munich, Germany

Summary

In this position you coordinate and manage regulatory activities to commercialize the Medical Devices manufactured and distributed by the Company in the International Area.

Essential Functions

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.

Knowledge, Skills and Abilities

Technical Scientific University master’s degree (e.g. Chemistry, Biology, Biotechnology, Pharmacy, etc.);
RAPS Society RAC designation is a plus;
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 international regulations (for example Asia, Middle East, Latin America etc.);
Knowledge of standards and regulations related to medical devices (EUMDR, ISO 13485, 21CFR820);
Knowledge of the fundamentals of SAMD, digital health or AI regulations;
Knowledge of the Windows Office package;
Fluent in English (spoken and written);
Knowledge of other languages would be a plus;
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.