Sr Regulatory Affairs Specialist
Nice To Have
- Engineering or Advanced degree desired.
- Excellent knowledge of U.S. and European/International regulations and standards
- Experience interacting with FDA and/or other regulatory agencies
- Previous experience in EU MDR
- Proven ability to prioritize, conduct, and manage time to meet project deadlines
- Must work well in dynamic and cross functional team environments
- Must demonstrate collaboration and leadership skills in team setting
- Proven analytical abilities
- Solid understanding of manufacturing and change control, and an awareness of regulatory trends
- Understanding of engineering concepts and scientific terminology
- Ability to understand, evaluate, and provide guidance on scientific literature, reports, and rationales
- Experience reviewing design specifications and other technical documents
- Superior interpersonal skills
- Excellent communication skills, both oral and written
- Documented evidence of writing skills
- Basic understanding of computer applications; proficient in Microsoft Office Applications
- Familiarity with medical terminology
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 physical demands described within the Responsibilities 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
Must be able to travel by plane and by car (10 - 20%), including International travel.
