Sr Regulatory Affairs Specialist - Patient Monitoring
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- 20000BT4 Количество требований
- 📅
- Fri 02 Oct 19:54 Дата публикации
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Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelor’s Degree with 4+ years or Regulatory Affairs experience in the medical device industry OR Advanced Degree with 2+ years of Regulatory Affairs experience in medical device industry.
Nice to Have (Preferred Qualifications)
- 4+ year regulatory submission experience
- Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
- Experience working with medical device or pharmaceutical regulatory submissions
- Working knowledge of IEC 60601-series standards
- Product experience with Radio Equipment Directive (RE-D)
- Prior experience with software-driven devices or Software as Medical devices (SaMD).
- Familiarity with regulatory requirements in major international markets
- Experience with EU- MDR
- Ability to comprehend principles of engineering, physiology and medical device use.
- Good analytical thinking skills.
- Ability to effectively manage multiple projects and priorities.
- Proficient computer skills.
- Experience with 510(k)/IDE/PMA device product submissions and other worldwide submissions and clearances.
- Experience performing advertising and promotion reviews for medical devices.
- Experience with FDA and international regulatory agency requirements
- Project management skills.
- Excellent oral and written skills.
- Excellent analytical thinking skills.
- RAPS certification (RAC)
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)
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)
