Principal Regulatory Affairs Specialist
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Must Have: Minimum Requirements
Nice to Have
- Bachelors degree in Science or Engineering (or related field) from an accredited college or university required
- Minimum of 7 years of medical device regulatory affairs experience or advanced degree with a minimum of 5 years experience
Nice to Have
- Excellent technical knowledge of medical products and understanding of relevant procedures, practices, and associated medical terminology.
- RAPS Professional Certification (RAC)
- 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
- Detail-oriented
- Ability to be flexible with changing priorities
- Excellent interpersonal skills to interface with project team members and able to contribute to the overall success of the team.
- Excellent written and oral communication, technical writing, and editing skills.
- Excellent leadership, interpersonal, and influencing skills.
- Ability to manage multiple projects and proficiency with Microsoft Office and software tools.
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 an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform 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.
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 an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform 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.
A commitment to our employees' lives is at the core of our values. We recognize their contributions. They share in the success they help to create. We offer many benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here.
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here.
The provided base salary range is used nationally in the United States (except in Puerto Rico and certain CA locations). The rate offered complies with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.
