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Tasks: Researching and consolidating global regulatory requirements and communicating this information to new project teams Writing and supporting key regulatory applications for new products and maintenance of existing products Partners with local regulatory affiliates and provides documentation to support international applications for new product and maintenance of existing products Reviews and approves product labeling and marketing material Assists with Senior Regulatory Director in the development of best practices for Regulatory Affairs processes Profile: Around 3 years related working experience. Degree qualified, preferably in a scientific or technical field with previous experience of working in a Regulatory or Compliance related role Experience of working within a highly regulated environment, preferably medical devices Familiarity with medical device laws and regulations in CFDA Working knowledge of MS Office programs (Word, Excel, PowerPoint, Outlook) and databases Familiarity with Adobe Acrobat Professional and electronic document management systems Excellent verbal and written communication skills Detail-oriented Strong interpersonal, negotiation and problem solving skills Ability to work independently and collaboratively with minimal supervision Ability to work under pressure within a fast-paced, multi-task team environment, appropriately prioritizing assignments and consistently meeting deadlines. Professional in Oral and written English |
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