Regulatory Affairs Specialist

Job description

Main Purpose of the Job

Ensuring Medtronic’s premarket and post market activities are followed in accordance to Israeli regulations and Medtronic standards in a proactive, timely, coherent, high quality way.  

·  Premarket activities such as local product registrations in  timely, organized, high quality methods.
·  Post market surveillance activities: execution & follow up on Field Actions, vigilance reporting, adverse events handling.
·  Strategic thinking from planning to execution and follow up for regulatory and quality Job Duties / Responsibilities:
·  Files / maintains medical device technical files and regulatory clearance submissions for various governmental offices- mostly MOH (AMAR).
·  Ensures compliance with pre- and post-market product approval requirements.
·  Responsibility in coordination between BU needs and regulators.
·  Maintain and update database of all Regulatory Registration for all Medtronic products in Israel.
·  Reviews advertising and promotion material ensuring it is consistent with approved claims for regulated products. 
·  Understands and applies regulatory requirements and their impacts for submissions.
·  Communicates changes in existing products to applicable RA representatives for determination of the need for new /revised licenses or registrations.
·  Work in close collaboration with BU and colleagues to gather needed information
·  Translation of regulatory requirements into practical plan.
·  Active involvement as required to meet schedules or resolve problems.
·  Follow up and lead for decisions to achieve results for meeting schedules and market introduction of new therapies.
·  Maintain and develop SOP for effectively Quality process implementation.

Desired profile

Qualifications & Requirements:

 

·  Bachelor's degree in a scientific discipline or equivalent, (preferred M.Sc)