Sr Regulatory Affairs Specialist - Transcatheter Mitral Valve Repair
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- 18000HUH N° de la demande de poste
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- Thu 08 Nov 11:53 Date de publication
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CVG (Cardiac and Vascular Group) Overview
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
DISCLAIMER:
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.
Must Have: Minimum Requirements
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Bachelor’s degree
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4+ years of experience in regulatory affairs or the medical device industry with Bachelor’s degree OR
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3+ years of experience in regulatory affairs, or the medical device industry with a Master's degree
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Experience working with medical device or pharmaceutical regulatory submissions
Preferred experience:
• 4+ years medical device industry experience
• Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
• Effective interpersonal skills
• Effective team member
• 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 Class II/III medical devices (510(k), PMA, IDE)
• Experience performing advertising and promotion reviews for medical devices
• Medtronic product development experience
• Clinical or statistical experience
• Experience with FDA and international regulatory agency requirements, ISOIGHTF standards
• Project management skills
• Advanced degree in a scientific discipline (engineering, physical/biological or health sciences).
• Effective interpersonal skills
• Effective team member
• 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 Class II/III medical devices (510(k), PMA, IDE)
• Experience performing advertising and promotion reviews for medical devices
• Medtronic product development experience
• Clinical or statistical experience
• Experience with FDA and international regulatory agency requirements, ISOIGHTF standards
• Project management 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.
• 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 by phone and in-person with peers and co-workers.
• Must be able to travel independently to various Medtronic buildings/sites or FDA locations.
• Must be able to travel by plane and by car.(<10%)
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.
• 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 by phone and in-person with peers and co-workers.
• Must be able to travel independently to various Medtronic buildings/sites or FDA locations.
• Must be able to travel by plane and by car.(<10%)
CVG (Cardiac and Vascular Group) Overview
The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. This group includes Aortic and Peripheral Vascular, Cardiac Rhythm and Heart Failure, and Coronary and Structural Heart products.
Within the Coronary & Structural Heart Group within CVG, this position will support our innovative Transcatheter Mitral Valve Therapy to treat mitral valve disease.
ABOUT MEDTRONIC:
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.
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.
EEO STATEMENT:
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.
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
DISCLAIMER:
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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