Medtronic

Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.

Bachelors degree in medical, Mechanical, Electric Life Science or other healthcare related majors. Set up new process for entering new data - Regulatory Information Management System.

Advanced degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related field. Demonstrated experience supporting regulatory submissions, registrations, compliance activities, and regulatory lifecycle management. Medtronic

Collaborates with various departments on the design, documentation, testing, and implementation of clinical data collection studies, and clinical database review.

Requires broad practical knowledge of operational systems and practices typically gained through extensive experience and / or education. Medtronic

Collaborates with various departments on the design, documentation, testing, and implementation of clinical data collection studies, and clinical database review.

Bachelors degree in Medical, Mechanical, Life Science or other healthcare related major. Works independently with general supervision on larger, moderately complex projects / assignments.

He, she participates in all activities relating to preparation, submission and follow up to obtain approvals, renewals for products and its variations and line extension indications and labeling approvals of medical devices of various business units of Medtronic. He, she will be responsible for providing technical support by interpreting federal and local regulations as they apply to products, processes, practices and procedures