Regulatory Affairs Specialist
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- 190008YG Stellenausschreibung Nr.
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- Wed 05 Jun 11:19 Posting-Datum
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• Bachelor’s degree preferably in engineering or a technical discipline with 2+ years of regulatory experience in the medical device industry.
• Master’s degree with 0+ years of medical device industry experience in regulatory affairs.
RTG (Restorative Therapies Group) Overview
The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
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.
Must Have: Minimum Requirements
• Bachelor’s degree preferably in engineering or a technical discipline with 2+ years of regulatory experience in the medical device industry.
• Master’s degree with 0+ years of medical device industry experience in regulatory affairs.
Preferred experience:
• Experience with medical device regulatory submissions.
• Experience with FDA, ISO, QSR, or EU regulations for handling complaints, reporting incidents, and implementing corrective and preventive actions.
• Experience in marketing materials review and the maintenance of compliant commercialization strategies.
• Experience in electro-mechanical medical devices.
• Experience with biocompatibility testing and sterilization validation preferred.
• Experience with international medical device consensus standards preferred.
• Good presentation skills.
• Excellent oral and written communication skills.
• Must be able to handle multiple tasks/projects and manage priorities accordingly.
• Ability to work in a team environment and exert influence without alienating others.
• Ability to work independently when required with minimal management oversight.
• Able to work within established guidelines and have flexibility as to method, priority and timing of job duties.
• This position requires a significant amount of initiative and judgment.
• Experience with FDA, ISO, QSR, or EU regulations for handling complaints, reporting incidents, and implementing corrective and preventive actions.
• Experience in marketing materials review and the maintenance of compliant commercialization strategies.
• Experience in electro-mechanical medical devices.
• Experience with biocompatibility testing and sterilization validation preferred.
• Experience with international medical device consensus standards preferred.
• Good presentation skills.
• Excellent oral and written communication skills.
• Must be able to handle multiple tasks/projects and manage priorities accordingly.
• Ability to work in a team environment and exert influence without alienating others.
• Ability to work independently when required with minimal management oversight.
• Able to work within established guidelines and have flexibility as to method, priority and timing of job duties.
• This position requires a significant amount of initiative and judgment.
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 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%)
RTG (Restorative Therapies Group) Overview
The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
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.
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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