Regulatory Affairs Manager

Job Description
Developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy.
• Together with professionals from other departments and in other countries, translate regulations and standards into product requirements
• Ensure product compliance to internal policies and external regulations and standards
• Responsible for the planning, coordination and preparation of document packages for regulatory submissions to the US, EU, Canada and Asia [e.g. 510(k)/PMA, CE Marking, Health Canada, Korea, CFDA].
• Review and approve engineering changes, advertising, promotional items and labeling for regulatory compliance.
• Maintain regulatory files and tracking databases as required
• Communicate with regulatory agencies as needed
• Implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy;
Skills and experience
• Bachelor/Master of Science degree in a software, technical, or biomedical discipline;
• 10+ years of experience in regulatory affairs, medical device regulated environment;
• Experience with successful preparation and submission of 510(k)/PMA and international documents for registration and/or marketing of medical devices worldwide;
• Excellent working knowledge of medical device regulations, FDA law, MDD, other global laws and regulations;
• Knowledge of FDA policies as well as familiarity with current FDA requirements and expectations
Experience in interacting with FDA and other regulatory agencies
• Experience in supporting international registrations (FDA) and clinical investigations (preference);
• Excellent working knowledge of medical device regulations, FDA law, MDD, other global laws and regulations
• Knowledge of the CFDA requirements is preferred;
• Thorough knowledge of medical device product development and design control.
• Excellent verbal and written communication skills in English; Analytical / systematic / logical thinker;