Regulatory Affairs Manager
To be considered for this role, please ensure the minimum requirements are evident on your resume.
5-7 years of regulatory or engineering experience with Bachelors
3-5 years of regulatory or engineering experience with Masters or other Advanced Degree
3+ years of experience providing work direction and/or leadership to people and teams
• Experience at formulating and implementing successful regulatory strategies
• Leadership capability (demonstrated)
• Highly motivated and results-oriented leader
• Proven expertise in all aspects of Regulatory Affairs; Strategy Planning, Submission Prep, All Phases of FDA Device Law/Regulations, Global Regulatory Requirements/Procedures, Project Management, Negotiations, Medtronic Product/Design/ Development Systems
• Proficiency in FDA compliance
• Excellent written and verbal communication, technical writing, and editing skills.
• Demonstrated advanced software skills including Microsoft Word, excel, database (i.e. RAD/Documentum) and Adobe software skills.
• Excellent Project-management skills and experience.
• Detail-oriented
• Ability to be flexible with changing priorities.
• Submission-related word processing skills
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Day in the Life section of this job description 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.
