Regulatory Affairs Specialist - Renal Access - International
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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.
• 2+ years of work experience in Regulatory Affairs/Quality Assurance with Bachelor’s degree.
• 1+ years of work experience in the Medical Device industry.
• 2+ years of work experience in Regulatory Affairs/Quality Assurance with Bachelor’s degree.
• 1+ years of work experience in the Medical Device industry.
Preferred experience:
• Working knowledge of global medical device regulations, including submissions.
• Demonstrated Microsoft Word, Excel and Adobe software skills.
• Experience working with cross-functional teams.
• Experience working with technical documentation/STED.
• Effective verbal and written communication skills.
• Experience with solving problems and concerns.
• Experience with project management and adherence to time schedules.
• Work well under pressure in a dynamic environment.
• Ability to multi-task effectively in fast-paced environment
• Highly organized, detail oriented, and efficient.
• Team player who seeks to help and learn from colleagues seeing the department success as their own
• Ability to manage small scale projects to completion within and outside of the direct department.
• Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
• Proactively seeks to develop and become well-versed within in the regulatory landscape.
• Regulatory Affairs Certification
• Demonstrated Microsoft Word, Excel and Adobe software skills.
• Experience working with cross-functional teams.
• Experience working with technical documentation/STED.
• Effective verbal and written communication skills.
• Experience with solving problems and concerns.
• Experience with project management and adherence to time schedules.
• Work well under pressure in a dynamic environment.
• Ability to multi-task effectively in fast-paced environment
• Highly organized, detail oriented, and efficient.
• Team player who seeks to help and learn from colleagues seeing the department success as their own
• Ability to manage small scale projects to completion within and outside of the direct department.
• Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
• Proactively seeks to develop and become well-versed within in the regulatory landscape.
• Regulatory Affairs Certification
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
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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