職位描述
職位描述：
Major Accountabilities
? Responsible for regulatory plans, submission, and approval of clinical trial and marketing authorization applications for assigned new products and life cycle management of marketed products in China.
? Monitor operational progression of pre-marketing authorization activities of responsible products in China.
? Develop and maintain excellent working relationships with CFDA; identify regulatory risks and communicate to supervisor to minimize those risks.
? Work with Surgical commercial colleagues to review promotional materials
Ideal Background
Education / General
? University degree or equivalent in biomedical field and higher degree with minimum 2 years experience in Regulatory Affairs required, not less than 3 years of which shall have been in a managerial role, interacting to affect direction and decision-making within development programs and in regulatory agencies.
Expertise/Experience/Skills
? Some knowledge of the regulations affecting the medical device industry in China; including both pre-market and post-approval regulations. A working knowledge of regulatory review and approval processes in other global markets
? Some Knowledge of the policies and regulatory climate within global health authorities.
? A history of positive working relationships with senior officials within major regulatory agencies and a track record of success in gaining regional drug/medical device approvals.
? Some Significant experience presenting to regulatory authorities.
? Action oriented with proven ability to move projects through to approval and commercial success.
? High energy, hands-on individual with a collaborative personal style and the ability to work well in a team environment.
? Transparent communicator..
