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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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