Principal Regulatory Affairs Specialist
To be considered for this role, please ensure the minimum requirements are evident on your resume.
- Bachelor’s degree with 7 years of work experience or Master’s degree with 5 years of work experience
- Experience in a Regulatory function/role
- Experience in developing and preparing regulatory submissions (i.e. Premarket Approval (PMA) for Class II and/or Class III medical devices.
Master’s Degree or Doctorate in Regulatory Affairs and Regulatory Affairs Certification (RAC) would be ideal.
Experience in IDEs, PMAs, 510(k)s, Amendments, Supplements, Annual Reports, 30 day Notices, Real Time Reviews, 180 Days, Design Dossiers, Technical Files and Notification to Notified Bodies.
Experience assessing changes to design, process, labeling, packaging, sterilization and software to products in the market and under development for Regulatory reporting.
Product experience with Radio Frequency (RF), Electromagnetic Compatibility (EMC), Software and Implantable devices
Knowledge of FDA and international regulatory agency requirements, ISO/GHTF standards and international medical device regulatory requirements.
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.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Day in the Life 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.
Ability to travel up to 10%
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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