Regulatory Affairs Manager - Ventilation
• Bachelor’s degree with 5+ years of experience in regulatory affairs in the medical device industry OR Advanced degree with 3+ years of experience in regulatory affairs in medical device industry.
• Experience interacting with FDA and/or other regulatory agencies
• Proven ability to prioritize, conduct, and manage time to meet project deadlines
• Must work well in dynamic and cross functional team environments
• Must demonstrate collaboration and leadership skills in team setting
• Proven analytical abilities
• Solid understanding of manufacturing and change control, and an awareness of regulatory trends
• Understanding of engineering concepts and scientific terminology
• Ability to understand, evaluate, and provide guidance on scientific literature, reports, and rationales
• Experience reviewing design specifications and other technical documents
• Superior interpersonal skills
• Excellent communication skills, both oral and written
• Documented evidence of writing skills
• Basic understanding of computer applications; proficient in Microsoft Office Applications
• Familiarity with medical terminology
• Some overnight travel required
• The employee is required to be independently mobile
• The employee must be able to travel independently to various Medtronic buildings/sites.
• The employee is required to interact with a computer, and communicate with co-workers
• The employee is required to travel by car and by airplane (<20%), including possible International travel
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.
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.
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