Regulatory Affairs Supervisor or Manager
- 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
- Bachelor’s degree in Biomedical, Mechanical, or Medical Device Engineering, Regulatory Science, Life Sciences, English or related medical/scientific field.
- Excellent written and verbal communications skills in both Chinese and English
- 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.
- Must have 2-3 year manager or supervisor experience and have at minimum 5 years project management roles.
- Excellent analytical thinking skills and ability to effectively manage multiple projects and priorities
- Proven ability to lead and work effectively in cross-functional teams
- Strong organization and time management skills
- Excellent communication skills
- Domestic and International travel required, less than 40%.