Senior Associate, Regulatory Affairs

Responsibilities Provides regulatory advice and support to assigned products/teams. Identifies and communicates registration needs and strategies. Maintains awareness of applicable regulations. Plans and organizes registration packages for device products. Prepares registration packages in line with local regulatory requirements and guidelines. With oversight, serves as a liaison with regulatory agencies pertaining to assigned products. Assists in the preparation of agency meeting packages and strategies for agency meetings. Evaluates manufacturing and labeling changes for regulatory impact. Accurately describes these changes for ease of regulatory agency review. Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review. Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions. May serve as a lead regulatory representative to an assigned product or project team. Requirements Must be at least 18 years of age High School Diploma required Bachelor’s degree from an accredited college in pharmacy, biology, chemistry, pharmacology, engineering or related subject or university is required Master’s Degree or P.H.D preferred RAC Certification preferred Seven plus years of experience in Medical Products Industry in Regulatory Affairs. Able to lead scientific arguments and apply analytical and logical reasonings. Ability to effectively prioritize workload and multitask with minimal supervision. Good interpersonal skills. Good oral and written communications skills. Demonstrated project management skills. Demonstrated critical thinking, contingency planning and negotiating skills. Understanding of regulatory and business needs with ability to establish direction and influence cross functional team members. #J-18808-Ljbffr