Regulatory Affairs Senior Specialist (Philippines)

Details of the offer

Be a local pioneer member of a global medical technology company from Singapore.Leverage your skills and learn the emerging technologies in healthcare. About Our Client Founded in 2019, Virtue Diagnostics is a company that creates advanced diagnostic tools and focuses on expanding into new markets. They have a skilled team and robust research and development facilities in several countries, and they use innovative technology to enhance cancer and chronic disease testing, particularly in China and other emerging markets. They began expanding into the Philippines in 2024.
Job Description Manage regulatory issues and implement compliance plans.Develop systems and procedures for tracking filings, certifications, and permits.Prepare registration requirements and coordinate with regulatory agencies for licenses and product registrations.Stay informed about changes in regulatory legislation and guidelines.Document product classifications and associated regulations.Ensure products meet regional regulations (e.g., BFAD, PDEA, FDA, BIR).Oversee logistics for importing goods and coordinate with customs and brokers.Monitor and store reagents properly (Room or Cold Storage).Maintain records for regulatory documents and goods using a First In-First Out system.Update research on product ingredients and purposes for inspections.Liaise with national reference laboratories and medical centers.Perform additional administrative tasks as assigned by the supervisor. The Successful Applicant A licensed professional (e.g. Pharmacist, Nurse, Medical Technologist)With at least 4 years of work experience in Regulatory Affairs within the in vitro diagnostics space.Amenable to work on-site in Marikina City, Philippines. What's on Offer Innovative Technology: Virtue Diagnostics leads in advanced diagnostic technologies and is expanding globally, offering a chance to work on cutting-edge projects in cancer and chronic disease testing.Career Growth: The company's strong R&D capabilities and expansion into new markets, including the Philippines, provide significant opportunities for professional development and career advancement.
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Nominal Salary: To be agreed

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