Becton Dickinson (BD) recently completed the acquisition of the Edwards Critical Care business.  This position is part of the Critical Care division, and as such will become a part of the BD organization in the future.  Critical Care will operate as a separate business unit, called Advanced Patient Monitoring (APM) within BD's medical segment, aligning with BD's smart connected care approach.   BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. If you are invited to interview for this position, a recruiter will provide further details about this exciting transition. Learn more about BD at bd.com 

Key Responsibilities:

• Prepare and review product registration tasks covering the new product registration, progress reports, supplements, amendment, periodic reports and the renewal registration
• Support and coordinate with other functions to fulfill company’s regulatory tasks mandated by other existing local healthcare regulations, such as the completion of the device registration and tracking monthly reports, the device advertising application, the facilitation of device import exemption and other new regulatory requirement projects assigned by the authority bodies.
• Maintain good relationship with government authorities to keep up to date on regulations changes and trends; seek advice on interpretation of government guidelines and regulations to ensure compliance
• Support and carry out company internal regulatory, quality and compliance processes investigation, recall FDA reporting
• Track timelines and document milestone achievements, develop regulatory strategy, prioritize strategies/submissions with operating plans as well as ensuring alignment with KOD in country/regions and provide regulatory updates to relevant stakeholders
• Obtain approvals from Ministry of Health/ Pricing Bureau/ other relevant authorities on the pricing and reimbursement levels
• Provide guidance and feedback to BUs on registration requirements for new and renewal registrations, product and process changes, and review of labeling content and guidance on process improvement projects.
• Maintain proper records in the Module Change Request and JDE system to comply with local and company regulatory and quality requirements.

Education and Experience:

• Bachelor's Degree in related field, 5 Years years experience Previous related experience. Coursework, seminars, and/or other formal government and/or trade association training Required and
• Other: in Scientific discipline (e.g., medical, pharma, Biology, Microbiology, Chemistry)Experience in preparing domestic and international product submissions Preferred

Additional Skills:

• Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
• Excellent written and verbal communication skills including negotiating and relationship management skills
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Full knowledge and understanding of country/regions regulations relevant to medical devices, Class II and/or Class III devices
• Full knowledge and understanding of country/ regions regulatory requirements for new products or product changes
• Good leadership skills and ability to influence change
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Work is performed independently on more complex projects and/or lines of work and reviewed for accuracy and soundness
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control