Regulatory Affairs Specialist - Spine
- 📅
- 190003S4 Numéro de demande de personnel
- 📅
- Mar 19, 2019 Date de publication
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Spine & Orthopedic Therapies Group:
Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.
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 in Engineering, Life Sciences, or related medical/ scientific field
• 2+ years of medical device experience with experience in regulatory affairs with a Bachelor's degree/ 6+ months of medical device experience with experience in regulatory affairs with a Master's degree
• Experience with 510(k) submissions
• 2+ years of medical device experience with experience in regulatory affairs with a Bachelor's degree/ 6+ months of medical device experience with experience in regulatory affairs with a Master's degree
• Experience with 510(k) submissions
Preferred Experience:
• Experience with US / International medical device regulatory submissions (including 510(k) submissions)
• Understanding of engineering concepts and scientific terminology
• Ability to understand, evaluate, and provide guidance on scientific literature, reports, and rationales
• Experience reviewing technical and design specifications
• Experience in medical device industry
• Superior interpersonal skills
• Excellent communication skills, both oral and written
• Proven ability to prioritize, conduct, and manage time to meet project deadlines
• Documented evidence of writing skills
• Basic understanding of computer applications
• Familiarity with medical terminology a plus
• Some overnight travel required
• Understanding of engineering concepts and scientific terminology
• Ability to understand, evaluate, and provide guidance on scientific literature, reports, and rationales
• Experience reviewing technical and design specifications
• Experience in medical device industry
• Superior interpersonal skills
• Excellent communication skills, both oral and written
• Proven ability to prioritize, conduct, and manage time to meet project deadlines
• Documented evidence of writing skills
• Basic understanding of computer applications
• Familiarity with medical terminology a plus
• Some overnight travel required
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 regularly required to be independently mobile.
• The employee is 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.
• The employee is regularly required to be independently mobile.
• The employee is 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.
Spine & Orthopedic Therapies Group:
Medtronic is a world leader in spinal and musculoskeletal therapies. The Spine & Orthopedic Therapies Group provides spinal fusion and artificial disc products from Medtronic, including bone graft options and minimally invasive spinal surgery options for patients.
Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.
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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