Senior Regulatory Affairs Specialist - Sterilization
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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 REQUIRED QUALIFICATIONS (MUST BE EVIDENT ON YOUR RESUME):
- Bachelor's Degree in chemistry, scientific or engineering discipline
- 4+ years of work experience in engineering or regulatory affairs within the medical device industry with Bachelor’s Degree
- 2+ years of work experience in engineering or regulatory affairs within the medical device industry with an advanced degree
NICE TO HAVE
- History of successful 510(k)/IDE/PMA device/supplement submissions and other worldwide submissions and clearances.
- 2+ years of experience in healthcare industry (i.e. medical device,IVD pharma/drugs, biologics, biotech)
- Expertise in 30-Day Notices and RTRs, Design Dossiers, and Technical Files
- Experience in assembling facts from various areas, analyzing data, and providing informed recommendations
- Product experience with sterilization for Radio Frequency (RF), Electromagnetic Compatibility (EMC), Software and Implantable devices and thorough knowledge of regulatory requirements
- Knowledge of US and international regulatory requirements including clinical regulations, design control, medical device submissions requirements, labeling and promotion regulations, quality control, auditing principles, and adverse event reports.
- Regulatory Affairs Certification (RAC)
- Must be able to write clear, understandable technical documents, i.e. regulatory documentation or scientific presentations.
- Ability to compile data and summarize results
- Organized, efficient, process-oriented; high attention to detail
- Effective interpersonal/communication skills
- Works well under pressure in a dynamic timeline-driven environment
- Ability to effectively manage multiple projects and priorities
- Demonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software skills
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)
