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 Regulatory Affairs Manager - Medical Devices

Details
Country: USA
Location: Illinois-Chicago US-IL-Chicago
Total applied: 29
Regulatory Affairs Manager - Medical Devices

~ Looking for an experienced Regulatory Affairs professional to join a leading medical device company ~  Our client is looking to add a Regulatory Affairs Manager to their team. As the Manager of Regulatory Affairs your duties will include but are not limited to:   Identify potential risk areas and create alternative courses of action using scenario planning. Evaluate labels and promotional materials to ensure conformity with local and global regulations. Maintain corporate and departmental principles. Institute leadership role on project development teams and guarantee communication with Regulatory Affairs and with other functional areas. Document all decisions and justifications developed. Maintain existing authorizations and develop regulatory plans for new products. Participate in Corporate operational efficiency. Monitor regulatory environment and guarantee compliance with company standards.  Requirements: Bachelor's degree in Science or Engineering (higher degree would be a plus) Minimum of 3 years experience in US regulatory submissions for hardware/software medical device regulatory submissions. Also, experience with development, industry practices, and regulations; international regulatory experience a plus. Communication, leadership, presentation and time management skills are a MUST. Ability to work with hardware and software engineers in design regulation and compliance standards. Identify compliance risks. Ability to identify and manage risks and problem solve independently and with others.  If you believe that you are qualified and you are interested in this position, please submit your resume and apply.  **** Only qualified candidates will be considered and contacted ****Click here to apply online MRINetwork is the largest and most successful search organization in the world. Each MRINetwork office is a single point of contact to over 1,100 offices in more than 37 countries, our candidates have access to the right jobs virtually anywhere in the world. LOCATION: US-IL-Chicago JOB CATEGORY: Biotech/R&D/Science TYPE: Full Time, Employee JOB REFCODE: 833

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