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Regulatory Affairs Supervisor or Manager

Job Description


  • Manage and prepare regulatory submissions including pre-market approvals, post-market reporting and changes, design dossiers, Device License Applications, post-approval reports, export certificates, and identify the needs and coordinate the activities for bench, animal and clinical testing; And interact with agencies, cooperate counterpart, third party consultant, etc.).
  • Conduct appropriate research to develop strong regulatory strategies for new products.
  • Working with Quality, Operations, Engineering and other internal groups investigate and recommend solutions to address potential regulatory issues.
  • Review and approve all Labeling (product, advertising and promotional) verbiage
  • Prepare regulatory submission for regulatory approvals Generate and maintain regulatory documents including but not limited to EU Design Dossiers and other geography applications based on current global regulatory requirements;
  • Review Change Orders and assess regulatory impact of product changes on Internal and International regulatory strategy and submissions per standard procedures;
  • Monitor emerging regulatory trends and integrate new requirements; Assist in keeping company informed of regulatory requirements
  • Provide regulatory support and leadership to product manufacturing transfers and for product design, manufacturing, packaging, sterilization, and labeling changes; provide product regulatory affairs leadership for product development and manufacturing;
  • Participate on Product Development teams, providing regulatory strategy, timelines, and direction
  • Support post market regulatory compliance activities for International product approvals and evaluate post-market incident reports and determine MDR requirements;
  • Develop and maintain regulatory affairs department procedures
  • Comply with applicable regulatory laws/standards and Company policies and procedures
  • Have the ability to lead the team, and work with cross functional team




  1. Bachelor’s degree in Biomedical, Mechanical, or Medical Device Engineering, Regulatory Science, Life Sciences, English or related medical/scientific field.
  2. Excellent written and verbal communications skills in both Chinese and English
  3. Must have 5-7 years of experience: in regulation of medical devices including compliance to relevant standards; with medical device submissions and clearances including worldwide medical device regulations; and, with current worldwide regulatory requirements of EU Medical Device Directive 2007/47/EC, and other geography medical device regulations.
  4. Must have 2-3 year manager or supervisor experience and have at minimum 5 years project management roles.
  5. Excellent analytical thinking skills and ability to effectively manage multiple projects and priorities
  6. Proven ability to lead and work effectively in cross-functional teams
  7. Strong organization and time management skills
  8. Excellent communication skills
  9. Domestic and International travel required, less than 40%.