Regulatory Affairs Specialist - US Peripheral Vascular
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Preferred experience:
Cardiac and Vascular Group (CVG):
The Cardiac and Vascular Group brings all of Medtronic’s 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
The CVG group includes Aortic and Peripheral Vascular, Cardiac Rhythm and Heart Failure, and Coronary and Structural Heart products. Aortic Vascular Products include Chronic Total Occlusion Devices, Directional Atherectomy Systems, Drug-Coated Balloons, Embolic Protection Devices, Guidewires, Infusion Therapy Products, Peripheral and Biliary Stents, PTA Balloons, Snares, Support Catheters
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.
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.
Must Have: Minimum Requirements
• Bachelor’s degree.
• 2+ years of medical device experience, with work experience in regulatory affairs with Bachelor’s degree.
• 6+ months of medical device experience, with work experience in regulatory affairs with Master’s degree.
• Experience in the preparation of 510(k) or PMA submissions for FDA and Technical Files for EU.
• 2+ years of medical device experience, with work experience in regulatory affairs with Bachelor’s degree.
• 6+ months of medical device experience, with work experience in regulatory affairs with Master’s degree.
• Experience in the preparation of 510(k) or PMA submissions for FDA and Technical Files for EU.
Preferred experience:
• Excellent analytical thinking skills
• Ability to effectively manage multiple projects and priorities
• Proven ability to lead and work effectively in cross-functional teams
• Excellent written and verbal communications skills
• Ability to work in matrix teams
• Strong organization and time management skills
• Demonstrated ability to influence based on experience, facts and data
• Highly motivated and results-oriented leader
• Project-management skills and experience
• Presentation skills for small to mid-sized groups
• Detail-oriented
• Ability to be flexible with changing priorities
• Submission-related word processing skills
• Knowledge of Quality System requirements and FDA and/or International product approval process.
• Ability to effectively manage multiple projects and priorities
• Proven ability to lead and work effectively in cross-functional teams
• Excellent written and verbal communications skills
• Ability to work in matrix teams
• Strong organization and time management skills
• Demonstrated ability to influence based on experience, facts and data
• Highly motivated and results-oriented leader
• Project-management skills and experience
• Presentation skills for small to mid-sized groups
• Detail-oriented
• Ability to be flexible with changing priorities
• Submission-related word processing skills
• Knowledge of Quality System requirements and FDA and/or International product approval process.
The Cardiac and Vascular Group brings all of Medtronic’s 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
The CVG group includes Aortic and Peripheral Vascular, Cardiac Rhythm and Heart Failure, and Coronary and Structural Heart products. Aortic Vascular Products include Chronic Total Occlusion Devices, Directional Atherectomy Systems, Drug-Coated Balloons, Embolic Protection Devices, Guidewires, Infusion Therapy Products, Peripheral and Biliary Stents, PTA Balloons, Snares, Support Catheters
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.
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.
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
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, and communicate with co-workers
• The employee is required to be independently mobile
• The employee is required to interact with a computer, and communicate with co-workers
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.
