Principal Regulatory Affairs Specialist (Remote)
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- 21000POW Numéro de demande de personnel
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- Mar 16, 2022 Date de publication
Must Have: Minimum Requirements:
- Bachelor’s degree
- Minimum 7 years of medical device regulatory affairs experience with Bachelor’s degree
- Minimum 5 years of medical devcie regulatory affairs experience with an advanced degree
Nice to Have:
- Demonstrated history of successful regulatory submissions in the US and EU
- Advanced degree in a scientific discipline
- Experience with regulatory support of clinical trials for medical devices
- Working knowledge of IEC 60601-series standards
- Previous experience with software-driven devices
- Experience in Pre-Sub, IDE, 510(k), De Novo, PMA, Technical File/Design Dossier
- Prior direct involvement with product development teams
- Strong interpersonal, analytical, writing, and organizational skills, including the ability to “navigate the grey”
- Ability to analyze and resolve non-routine regulatory issues using independent judgment
- Working knowledge of FDA requirements, guidance documents, Medical Device Directive (93/42/EEC), Medical Device Regulation (EU 2017/745), ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
- Good understanding of product development process and design control through knowledge of US FDA and international medical device regulations
- RAC credential preferred
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)
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Learn more about our benefits: benefits.medtronic.com
This position is eligible for a short-term incentive plan. Learn more about Annual Salary and Medtronic Incentive Plan (MIP) on Page 6 here
Salary Min: $109,600 Salary Max: $164,400