Senior Regulatory Affairs Specialist
- Bachelor’s Degree and a minimum 4 years of medical device experience, with work experience in regulatory affairs, OR advanced degree and a minimum of 2 years of medical device experience, with work experience in regulatory affairs.
- History of successful 510(k)/IDE/PMA device submissions and other worldwide submissions and clearances.
- Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
- Excellent analytical thinking skills
- Ability to effectively manage multiple projects and priorities
- Proven ability to lead and work effectively in cross-functional teams
- Excellent written and verbal communications skills
- Ability to work in matrix teams
- Strong organization and time management skills
- Demonstrated ability to influence based on experience, facts and data
- Highly motivated and results-oriented leader
- Project-management skills and experience
- Presentation skills for small to mid-sized groups
- 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 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)