Quality and Regulatory Director

Major responsibilities include:
· Fully implement the quality management system and ensure that the company is in compliance with standards and regulations (e.g., QSR, CMDR and MDD).
· Responsible for implementing most aspects of the quality system including document and data control, management responsibility (including management review), quality planning, training, vendor approval / monitoring, process validations, corrective and preventive action system, internal quality audits, non-conforming materials and incoming inspection.
· Responsible for promoting awareness of regulatory and customer requirements.
· Responsible for ensuring that all regulatory requirements are met including regulatory filings, technical files, external audits and change notices, etc.
· Participate as applicable in design control and risk management as quality assurance representative.
· Development and execution of regulatory strategies to support timely approval of regulatory applications in support of the company's corporate objectives.
· Ensuring regulatory compliance within all markets in which company’s products are marketed.
· Directs and executes regulatory activities for investigational and marketed products ensuring regulatory compliance is maintained and regulatory clearances are obtained in an efficient and effective manner.
· Prepares and submits worldwide regulatory market applications in support of the Company's corporate goals.
· Interfaces directly with regulatory agencies (FDA and notified bodies)
· Manages regulatory budgets
· Risk management
· Handle the MDR, Vigilance and customer complaint reporting of company’s products
Qualification/Education:
· B.Sc or M.Sc degree in the life sciences
· Must be knowledgeable in quality affairs
· Must be knowledgeable in FDA regulations and international regulatory requirements
Experience Requirements:
· Extensive experience in quality affairs
· Minimum of 3 years in a Good Manufacturing Practice environment, preferably within a manufacturing environment
Skills:
· Excellent verbal and written communication skills in English
· Able to prioritize work flow daily and execute on multiple priorities in a fast paced environment
· Proficiency in Microsoft Office Suite