Senior Regulatory Affairs Specialist - Surgical
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- 1900004G Stellenausschreibung Nr.
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- Tue 15 Jan 18:19 Posting-Datum
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MINIMUM REQUIRED QUALIFICATIONS (MUST BE EVIDENT ON YOUR RESUME):
• Bachelor's Degree in scientific or engineering discipline
• 4+ years of medical device experience, with work experience in regulatory affairs with Bachelor’s Degree.
• 2+ years of medical device experience, with work experience in regulatory affairs with Master’s Degree.
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
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.
MINIMUM REQUIRED QUALIFICATIONS (MUST BE EVIDENT ON YOUR RESUME):
• Bachelor's Degree in scientific or engineering discipline
• 4+ years of medical device experience, with work experience in regulatory affairs with Bachelor’s Degree.
• 2+ years of medical device experience, with work experience in regulatory affairs with Master’s Degree.
DESIRED/PREFERRED QUALIFICATIONS:
• Advanced degree and/or Regulatory Affairs Certification from RAPS
• Demonstrated successful history of submissions to FDA and notified bodies
• Working knowledge of IEC 60601-series standards
• Prior experience with software-driven devices
• Familiarity with regulatory requirements in major international markets
• Good understanding of design control requirements
• Experience with risk management
• Demonstrated successful history of submissions to FDA and notified bodies
• Working knowledge of IEC 60601-series standards
• Prior experience with software-driven devices
• Familiarity with regulatory requirements in major international markets
• Good understanding of design control requirements
• Experience with risk management
PHYSICAL 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 with peers and co-workers.
• Must be able to travel independently to various Medtronic buildings/sites.
• Must be able to travel by plane and by car.(<10%)
• 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.
• Must be able to travel independently to various Medtronic buildings/sites.
• Must be able to travel by plane and by car.(<10%)
MITG Surgical Innovations Group Overview
The Surgical Innovations Group, within the Minimally Invasive Therapies Group (MITG), brings together Medtronic and Covidien’s experience creating energy based surgical devices. Our trusted technologies deliver performance and inspire confidence through a comprehensive approach that takes every element of a patient’s health into careful consideration.
This is a 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 is a 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
Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.
Medtronic is a $29.7b company with 90,000+ employees in more than 160 countries.
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.
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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