Regulatory Affairs Specialist - EU
• 2+ years of work experience in Regulatory Affairs/Quality Assurance with Bachelor’s degree.
• 1+ years of work experience in the Medical Device industry.
• 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
• The employee is required to be independently mobile
• The employee is required to interact with a computer, and communicate with co-workers
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
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