Regulatory Senior Manager, Global Standards & Regulations

LivaNova

Munich, Germany

Position Summary

This position coordinates and manages standards and regulations surveillance process supporting of all LivaNova regulatory operations. This position reports to the Regulatory Affairs, Innovation department, to supervisor Senior Director, International Regulatory Affairs.

Resposibility and Authority

Support of processes related to global regulatory operations
External Documents: administration of global processes for the monitoring, control, and communication of external documents applicable to LivaNova medical devices (e.g. international standards, medical device laws and regulations, regulatory guidance)
Maintain electronic libraries and other resources to ensure LivaNova global access to current standards
Influence and contribute to the development of standards through active participation in external standards organizations and other affiliated industry organizations

Primary Activities/Duties

Responsible for execution of global external documents process, including periodic screening meetings and associated tasks
Establish, update, and maintain policies to ensure compliance with regulatory requirements regarding standards
Responsible for generating/updating data and metrics used to update senior management on a periodic basis
Identifies procedures and best practices for control of external documents
Identifies and drives efforts for continuous improvement of external document processes
Complies with US FDA regulations, other regulatory requirements, Company policies, operating procedures, processes and task assignments
Maintains positive and cooperative communication and collaboration with all levels of employees, customers, contractors and vendors

Additional Activities

Performs other related duties and responsibilities, on occasion, as assigned
This position may require business travel (less than 10 %)

Skills, Requirements and Qualifications

BS degree in an Engineering or technical discipline (Electrical, Mechanical, Biomedical, or Computer preferred) or science
Knowledge and understanding of medical device/quality system related standards, and in the design, development, and distribution of medical devices
Experience working in a broader enterprise/cross functional business preferred
Experience in standards development
Strong research and organizational skills
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
Proficient in MS Office tools (Outlook, PowerPoint, Word, and Excel)
Fluent English language skills, written and spoken; German language would be a plus