Assoc Regulatory Affairs Spec
Must Have:
- Bachelor’s Degree in health profession, science and/or engineering field, RAC
- One year Medical Device industry experience
Nice To Have:
- Master's Degree in Regulatory Affairs
- Demonstrated experience in preparing 510(k) submissions for FDA
- Experience with multiple device classes are a plus
- Demonstrated experience with submission to the European Union
- Excellent written and oral communication skills
- Computer literacy, proficiency in MS Word, Excel, PowerPoint, etc.
- Excellent organizational skills and attention to detail
- Working knowledge of MS Access, MS Project, and Adobe Acrobat Pro.
- High learning aptitude and adaptability with software systems
- Demonstrated technical writing skills.
- Other Skills Multi-tasks and prioritizes effectively in fast-paced environment
- Highly organized, detail oriented, and efficient.
- Highly self-motivated
- Team player who seeks to help and learn from colleagues seeing the department success as their own
- A problem solver and critical thinker that relies on own judgment for appropriate level of decision making
- Ability to manage small scale projects to completion within and outside
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.