Medtronic is an Equal Opportunity/Affirmative Action Employer
Coordinates and prepares document packages for regulatory submissions from all areas of company, internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Monitors and improves tracking / control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications.
Knowledge: Applies advanced in-depth knowledge in one job family or broad knowledge across a job function.
Problem Solving: Provides solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practical, and consistent with organization objectives.
Discretion / Latitude: Works under only general direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.
Impact: Exerts some influence on the overall objectives and long range goals of the organization and contributes to the completion of work group objectives. Failure to obtain results or erroneous decisions or recommendations would typically result in moderate impact on customers and/or results and considerable expenditure of resources.
Liaison: Internal interactions extend beyond the immediate work group and include frequent interaction with management. External interactions are primarily to solve problems or improve processes.
Adhere to the Medtronic Core Behaviors of Customer Focus, Candor, Trust and Respect, Courage, Accountability, and Passion to Win.
Bachelors degree with a minimum of 4 years of related experience, Or
Masters degree with a minimum of 2 years of related experience
?Knowledge of FDA medical device regulations and guidance
?Knowledge of product development processes
?Experience with 510(k) submissions and FDA interactions from time of submission through clearance
?Experience writing technical files for CE mark and exposure to other international regulatory requirements and systems
?Understanding of change control and promotional requirements for medical devices
Demonstrated management of regulatory submissions activities
Proficient in timely review of technical and clinical data
Ability to work independently and with minimal supervision
Ability to mentor junior associates
Strong analytical skills, with the ability to analyze technical requirements and regulations which apply to the corporation
Computer skills; MS Office, Adobe Acrobat, document processing/publishing tools
Physical Job Requirements
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to stand; walk; and use hands to finger, handle, or feel objects, tools, or controls. The employee is occasionally required to reach with hands and arms. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job involve normal vision.
Medtronic, Inc. is engaged in medical technology. The Company functions in seven operating segments that manufacture and sell device-based...