This is a fully remote position, open to applicants in Vietnam, +1 more country.

📋 Description

• Oversee the preparation, compilation, review, and submission of regulatory documents for registrations, renewals, amendments, annual reports, and other regulatory activities.

• Manage the tracking, indexing, archiving, and upkeep of both paper and electronic regulatory records and submissions.

• Assess submission documentation for completeness, accuracy, and adherence to regulatory requirements and internal standards.

• Collaborate with cross-functional teams to gather, organize, and maintain documentation that supports regulatory filings.

• Monitor regulatory activities, submission timelines, and system records to facilitate compliance and reporting obligations.

• Assist with regulatory labeling initiatives by offering recommendations that align with relevant regulatory requirements.

• Maintain regulatory databases, systems, and tools to ensure precise documentation and traceability of regulatory information.

• Keep abreast of regulatory changes and relay pertinent updates that could influence submission strategies, processes, or compliance activities.

⛳️ Requirements

• Bachelor’s Degree in Medical Sciences, Biological Sciences, Engineering, or a related technical field.

• At least 3 years of experience in regulatory affairs, regulatory operations, quality assurance, clinical research, or a related area within a medical device, pharmaceutical, contract research organization (CRO), or other regulated environments.

• Proficient in business-level English for reading, writing, and speaking.

• Proficiency in Korean language equivalent to TOPIK II Level 3 or Level 4, with the capability to read, write, and communicate professionally in Korean.

• Understanding of Korean regulatory requirements and the regulatory submission processes.

• Competent in Microsoft Office applications, including Excel, Word, and PowerPoint.

🏝️ Benefits

• Flexible Work Arrangement.

• Medtronic Incentive Plan (MIP) short-term incentive.

• Flexible Benefits Package.

• A comprehensive range of benefits, resources, and competitive compensation plans tailored to support employees at every stage of their career and life.