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Regulatory Affairs and MDR Specialist - Medtronic Care Managment Services

Regulatory Affairs
18000GHF Requisition #
Thanks for your interest in the Regulatory Affairs and MDR Specialist - Medtronic Care Managment Services position. Unfortunately this position has been closed but you can search our 2,001 open jobs by clicking here.
Must Have: Minimum Requirements
• Bachelor’s degree.
• Experience in regulatory submissions, post-market regulatory affairs, and medical device reporting, including 510(k) Regulatory Submissions, Class I, II medical devices
• 2+ years of regulatory, product performance or returned product analysis experience in a regulated environment.
Preferred experience:
• Knowledge of Global regulatory requirements
• Experience in regulatory submissions for products requiring IEC 60601, FCC and EMC testing compliance
• 21CFR Part 820, Quality System Regulation
• 21 CFR Part 803, Medical Device Reporting
• 45 CFR Parts160 and 164, Patient Privacy Rule- HIPPA Regulations
• ISO 13485, Quality Systems, Quality Management Systems
• AIMD Directive: 90/385/EEC
• MDD Directive (Council Directive 93/42/EEC for Medical Devices)
• PC 1998-783 - Canadian Medical Device Regulation (CMDR)
• TGA : Therapeutic Goods Administration regulation for medical devices
• Master of Science Degree
• Quality systems experience
• Project management skills
• Experience with PMAs
• Excellent oral and written skills
• Effective team member
• Ability to comprehend principles of engineering, physiology and medical device use
• Excellent analytical thinking skills
• Ability to effectively manage multiple projects and priorities
• Strong communication skills required to interact with internal cross-functional partners and Medtronic field personnel
• Strong analytical skills
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.
• The employee is required to be independently mobile
• The employee is required to interact with a computer for 8 hours per day
• Must be able to communicate with colleagues, external customers, and healthcare professionals (nurses, doctors, etc.) in a clear, concise, professional, knowledgeable, and friendly manner

Medtronic Care Management Services (MCMS):
MCMS provides world-class remote monitoring for value-based healthcare at home.
What if you could monitor your patients at home, and avoid unnecessary healthcare utilization through the use of technology, connected data, and personalized care coordination? Helping clinicians deliver the right care, to the right patients, at the right time, Medtronic Care Management Services (MCMS) is committed to enabling value-based care at home.
Since 1998, MCMS has recorded over 5 million telehealth patient months, and currently services over 95,000 patients with its innovative remote monitoring solutions. As a trusted provider to hospitals, post-acute providers, and payers, we are committed to improving patient health — and delivering economic benefits — to the healthcare system every day.
Patient Management Programs include: Remote Patient Monitoring Systems, Software & Analytics, and Patient Advocacy & Support Services.
Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can 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.

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.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.


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