The Director serves as the head of the Quality Management and Regulatory Affairs team and leads, manages, and supports all medical device Quality System and Regulatory activities. Serves as Management Representative and Person Responsible for Regulatory Compliance (PRRC).
Responsibilities:
Qualifications and Educational Requirements
Education: BS Chemistry, Biology, Biomedical Engineering, or similar scientific/technical field. Working knowledge of cGMP, ISO 13485, and EU Medical Device Directive (MDD)/Regulations (MDR). Fluent in English. Spanish is a plus.
Communication skills: Position involves contacts with individuals inside and/or outside the Organization where the nature of the information provided usually follows an established pattern. Excellent verbal and written communication and skills.
Technical Proficiencies: Organizational Skills, Excel, Minitab, Presentation Skills, Project Management, Results Driven, Mathematical Skills, Technical Capacity, Thoroughness, Time Management.
Judgment and Decision Making: Collect, interpret, and/or analyze complex data and information. Demonstrated proficiency in supervising and motivating subordinates. Proven ability to handle multiple projects and meet deadlines.
Experience: Minimum of 5-10 years regulatory/quality assurance or quality engineering supervisory experience in an FDA registered facility for medical device manufacturing. Requires thorough knowledge of FDA Quality System Regulation (QSR) experience for medical device manufacturing. Knowledge of the Medical Device regulations and their appropriate application is needed to assure compliance with regards to manufacturing.
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