Compliance

• Responsible for the daily operations of regulatory affairs and assures regulatory submissions meet local and regional compliance requirements.
• Staying abreast with regulatory compliance requirements and changes affecting company operations and products.
• Generates and manages submission documents for new products or changes to existing regulatory submissions.
• Writing, preparing, submitting regulatory documents for the South-East Asia (SEA) market (Arthrex distributor and subsidiary).
• Communicating with regulators on submission projects.
• Prioritising and organising multiples projects with competing priorities.
• Participating in regulatory affairs planning for SEA markets.
• Providing support in APAC level projects as and when needed.
• Reviewing product labelling and Directions for Use (DFU), if any translation is required.
• Maintaining critical regulatory information such as product license, submission dossier, change information on the Regulatory Information Management System (RIMS) and other applicable databases.
• Evaluate and address changes to existing products to ensure compliance with local regulatory requirements.
• Assess and communicate impact of product change information to relevant stakeholders.
• Proactively attending seminars, lectures and academic conferences to continuously develop skills and to collect and share insights.
• Keeping abreast with the latest regulatory updates within SEA relating to Arthrex products and ensuring Arthrex as a company is aware, ready and able to comply with the necessary changes.
• Providing input to change management projects for global regulatory change assessments.
• Participating and providing support in cross-functional collaboration on new product and country launches.
• Supporting product safety alert activities and field actions.

Regulatory Affairs Specialist, SEA

Regulatory Reporting Solution Sales Specialist