Principal Regulatory Affairs Specialist - Robotics Platform
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- 20000ILB Количество требований
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- Fri 04 Jun 18:30 Дата публикации
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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 Have: Minimum Requirements
- Bachelor’s Degree in science, math or engineering discipline.
- Minimum 7 years medical device industry experience with 5 years regulatory experience.
- Or advanced degree with
Nice to Have
- Advanced degree.
- R.A.C certification(s).
- Experience with US De novo and Class III device submissions, including IDE and software-containing devices and medical device capital equipment and IEC 60601-1:2005
- Minimum US Class II and EU Class IIb device experience and in-depth knowledge of US FDA regulations (Title 21) and EU medical device directive (93/42/EEC) and EU medical device regulations MDR 2017/745.
- History of successful US 510(k) device submissions, Q-submissions, EU technical files, and experience with regulatory support of clinical trials.
- Knowledge of GLP/GCP requirements.
- Excellent negotiation skills.
- Excellent written/oral communication skills.
- Thorough knowledge of other regulations pertaining to the legal commercialization of medical devices.
- Thorough/Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), EU Medical Device Regulation (MDR 2017/745) and ISO 13485:2016
- Regulatory compliance competency (Inspections, Audits, Field Actions, Quality Systems)
- International regulatory competency.
- Clinical trial experience.
- Proficiency in FDA compliance.
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)
