New Product Development – 60%

• Act as Subject Matter Expert (SME) and Regulatory Affairs lead for the new product development projects, provide "solution-based" advice to development teams
• Develop and maintain regulatory strategies for new and modified product / product families
• Prepare and execute regulatory filings such as pre-IDEs, premarket notifications, technical files, Canadian submissions, and letters to file.
• Conduct international registrations following and in support of regulatory strategies
• Provide input on and approve product labels and labeling including language requirements worldwide.
• Support set up and management of outside vendors such as License holders and In Country agents [including importers, and distributors], as needed.
• Perform regulatory research to find predicate and support new product development as needed

Change Management – 20%

• Provide regulatory guidance on changes to existing products.
• Monitor global regulatory intelligence and provide impact evaluation to changing regulations.
• Performing regulatory impact assessments for engineering changes
• Review and approve promotional materials, 

Post Market – 10%

• Provide regulatory input to support post market surveillance and vigilance activities.
• Support Health Hazard Assessments and Field Actions as needed.

Leadership – 10%

• Support generating a strong Quality culture within the Clinical Business Unit through effective collaboration with peers.
• Act as Subject Matter Expert within 3rd party and internal audits.
• Manage and maintain Regulatory Affairs internal policies and procedures.
• Guide regulatory specialists as needed to support regulatory and/or clinical strategy requirements.

• Bachelor’s degree required preferably in Analytical Chemistry, Biochemistry, or Biomedical Engineering. Graduate education is preferable.
• Experience in Asia Pacific (APAC) IVD regulations.