Diagnose and resolve production quality problems with our CMO partners, and set production/quality standards before a new product goes into manufacturing
Diagnose and resolve production quality problems with our CMO partners, and set production/quality standards before a new product goes into manufacturing
Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.
Supports in developing partnerships with quality assurance, manufacturing, program management, product development, and marketing to ensure product compliance and timely product clearances and/or approvals.
Plan and deliver assigned product LCM activities in line with market plans, agreed priorities, internal objectives, local requirements and applicable global procedures.
Support regulatory compliance and product stewardship activities across APAC, ensuring processes and documentation align with applicable regional and country-specific requirements.
Direct experience authoring or reviewing clinical study reports, protocol synopses, or regulatory dossier modules for a pharmaceutical, biotech, or CRO organization
Coordinate end‑to‑end regulatory compliance requirements across all DFI selling markets for Health & Beauty indent products and execution, ensuring that they meet applicable government legislation and DFI standards.
Supports in developing partnerships with quality assurance, manufacturing, program management, product development, and marketing to ensure product compliance and timely product clearances and/or approvals.
For assigned products and under supervision of Associate Director ensures timely preparation, submission and appropriate follow-up of new Marketing Authorization applications to local authorities.
Develops product registration plans and strategies and working cross-functionally to review and communicate the registration strategy with minimal oversight.
Manage and coordinate regulatory compliance obligations for EDOTCO Malaysia and its relevant Malaysian entities, including licensing, competition, access, technical, USP and other applicable regulatory requirements.
Lead end-to-end regulatory registration activities for Class C medical devices across assigned Southeast Asian markets, including regulatory strategy, technical documentation, product testing, clinical evaluations, quality system documentation, and submissions.
Develop and maintain strong relationships with internal regulatory teams, affiliates, and distributors to ensure effective stakeholder management and operational excellence.