Regulatory Affairs Executive

We are looking for a qualified professional to manage regulatory affairs, with a focus on GDPMD (Good Distribution Practice for Medical Devices), CDAKB (Indonesia), and product registration under the Medical Device Authority (MDA) Act. This position entails ensuring compliance of medical devices with local regulations and standards, preparing and submitting registration applications, maintaining comprehensive product documentation, and coordinating with relevant regulatory authorities.

Job Description:

• Supervise and manage the entire product registration process, ensuring strict adherence to regulatory requirements and timely submission of all necessary documentation.
• Strategically plan, coordinate, and execute Regulatory Affairs (RA) activities within the assigned region, ensuring alignment with both regulatory standards and company objectives.
• Oversee the complete regulatory lifecycle of products, including initial submissions, approvals, variations, renewals, and ongoing maintenance in collaboration with national regulatory authorities.
• Conduct feasibility assessments for new product imports, ensuring compliance with national regulations and market entry strategies.
• Compile, prepare, and review all required documentation for product registrations, ensuring submissions meet the necessary regulatory standards for approval.
• Act as the primary liaison with national regulatory authorities, developing and presenting strategies for new product submissions and portfolio management.
• Cultivate and maintain strong professional relationships with regulatory agencies to facilitate effective communication and negotiation on regulatory issues.
• Monitor and stay informed about regulatory developments and trends, offering strategic advice on their potential impact on current and future product registrations.
• Provide cross-functional support to internal teams, including marketing, sales, and R&D, ensuring that regulatory compliance is seamlessly integrated into product development and commercialization processes.
• The RA region will not be limited to SIM but will also include other ASEAN countries where exports to distributors are anticipated.
• Coordinate with the RA team at Menicon HQ to advance updates and registration tasks.

Job Requirements:

• Degree holder in Science/Nutrition or a related field.
• At least 1 year of experience as a Regulatory Affair.
• A good command of spoken and written English and Bahasa Malaysia.
• High attention to detail, with strong analytical and problem-solving abilities.
• Ability to manage multiple projects simultaneously and prioritize tasks in a fast-paced environment.
• Proven track record of successful product registrations, regulatory submissions, and lifecycle management in the pharmaceutical or healthcare sector.

Must have own transportation and be willing to travel when necessary for work purposes.