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Years of Experience
Date Last Verified
ProfileDirector Quality and Regulatory Affairs Duties: Manage all quality and regulatory aspects of products throughout their lifecycle. Responsible for the overarching global quality and regulatory strategy, and managing interactions with various regulatory authorities. Provides directional guidance to the business on how to prepare products for approval and keeps abreast of evolving global regulatory requirements. Leads Quality and Regulatory Affairs personnel associated with the product lifecycle (which includes Quality Assurance, Regulatory Product Development, Advertising and Promotion, Labeling), and evaluation of changes to product, process, facilities, etc. Leads and develops personnel to promote compliance with all laws, regulations, and guidance. Serve as a leadership team member for Quality and Regulatory Affairs function. Oversee the development of global product quality and regulatory strategies for all products. Oversee the regulatory functions in relation to device design and development and product approvals, consistent with agreed upon timelines. Manage interactions with Regulatory Authorities for products. Provide regulatory support to other functions (e.g., Development) during Regulatory Authority inspections. Provide regulatory guidance/input to internal product review boards. Select, develop, and motivate a quality and regulatory team that supports personal growth and a culture of compliance. Play a significant role in the performance management process and career development programs for supervised quality and regulatory personnel.
Qualification and Experience
Requirements: Bachelor’s degree in science or health related field. Advanced degree highly preferred (PhD, MD, E/JD Degree , MJ, MS, or equivalent). 10+ years medical device industry with regulatory experience, medical software a plus. Knowledge of regulatory affairs discipline throughout the product lifecycle, including Design, Development, Promotion and Advertising, Labeling, Change Control, Commercialization, and Operations. Knowledge of domestic and international laws, regulations, and guidance. Knowledge of clinical development, including responsibilities for successful management of development milestones and global market authorization. Ability to influence and partner with cross-functional teams. Ability to take innovative ideas and design a successful product regulatory strategy and, in so doing, increase probability of regulatory approval. Ability to support the product development team to assess whether technical arguments are presented clearly and conclusions are adequately supported by data. Strong capability to lead and support a collaborative team environment. Ability to manage in a highly matrix organization. Demonstrated ability to lead a multidisciplinary team. Strong business acumen and ability to see the business drivers outside of Quality Assurance and Regulatory Affairs. Excellent communication skills; both oral and written. Strong interpersonal skills with the ability to influence others in a positive and effective manner. Ability to contribute to a continuous learning and process improvement environment. Capacity to react quickly and decisively in unexpected situations. Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies. Focused ability to influence operational excellence and performance metrics. Risk adverse where needed with the ability to identify potential solutions to complex problems.