Regulatory Affairs Specialist - EU
Thanks for your interest in the Regulatory Affairs Specialist - EU position.
Unfortunately this position has been closed but you can search our 1,336 open jobs by clicking here.
• Knowledge & experience with US FDA, EU Medical Device Directive (MDD) 93/42/EEC, CE mark process, and industry standards and policies.
• Exposure to EU Medical Device Regulation (EU MDR) 2017/245.
• Familiarity and implementation of international and domestic standards.
• Working effectively with diverse cultural groups in a fast-paced environment.
• Strong technical writing and verbal communication skills.
• Computer literacy, proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat Pro, etc.
• High learning aptitude and adaptability with software systems.
• Excellent organizational and multi-project management skills, with specific attention to detail.
• Medical device product remediation experience (i.e DHF, Technical Doc) preferred
• Regulatory Affairs Certification
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:
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:
• Knowledge & experience with US FDA, EU Medical Device Directive (MDD) 93/42/EEC, CE mark process, and industry standards and policies.
• Exposure to EU Medical Device Regulation (EU MDR) 2017/245.
• Familiarity and implementation of international and domestic standards.
• Working effectively with diverse cultural groups in a fast-paced environment.
• Strong technical writing and verbal communication skills.
• Computer literacy, proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat Pro, etc.
• High learning aptitude and adaptability with software systems.
• Excellent organizational and multi-project management skills, with specific attention to detail.
• Medical device product remediation experience (i.e DHF, Technical Doc) preferred
• 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.
Come for a job. Stay for a career.
