Senior Regulatory Affairs Specialist
- Bachelor’s degree.
- Minimum 4 years of experience in medical device regulatory affairs, quality, or engineering with Bachelor’s degree
- Or minimum 2 years of experience in medical device regulatory affairs, quality, or engineering with Master's degree.
- 4+ years medical device industry experience
- Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
- Experience with Class II/III medical devices (510(k), PMA, IDE)
- Experience performing advertising and promotion reviews for medical devices
- Medtronic product development experience
- Clinical or statistical experience
- Experience with FDA and international regulatory agency requirements, ISOIGHTF standards
- Project management skills
- Effective interpersonal skills
- Effective team member
- Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.
- Ability to effectively manage multiple projects and priorities.
- Proficient computer 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.