Job Description

Exciting role for Regulatory affairs professionals who are based in Perak. A great opportunity to work with a medical device established manufacturer and manage global products registrations and export licensing in other countries.

• Ensure that the company\'s products adhere to country regulations.
• Handle the testing process for gloves, including completing necessary paperwork and coordinating with external laboratories.
• Assist superiors in preparing Purchase Requisitions (PR) for glove testing and ensure timely payments.
• Update external documents with new revisions such as standards, regulations, and guidance.
• Revise training materials and procedures according to updated standards and regulations for relevant countries.
• Refresh the product portfolio every six months.
• Ensure quality standards are met, and submissions adhere to strict deadlines.
• Maintain and update FMEA, Risk Management File, Post Market Surveillance, and Clinical Evaluation.
• Be prepared for transfer to other departments at the company\'s discretion.
• Ensure RA areas and storage areas are audit-ready and comply with Good Distribution Practice (GDP) and current Good Manufacturing Practice (cGMP).
• Ensure all work activities are environmentally compliant and follow Good Environmental Practices (GEP).
• Comply with all relevant legislation, including OSHA, FDA, and EQA

Established local Medical Device Company|Great career opportunities

• Bachelor\'s degree or professional qualification, preferably in Science/ Pharmacy
• Min 2 years of working experience in RA, QA or a testing lab; min 8 years of experience for managerial position
• Good problem solving skills and communication skills
• For this Managerial position, looking for applicants with:-

• ISO 13485 Medical Devices experience
• Knowledge of RA framework in the Region (SEA/APAC) - Global experience will be a major advantageous
• High level of communication skills in English and other Asian or European languages.

Our client stands as a local established glove manufacturer in Malaysia, they are one of the market leaders in manufacturing and exporting their products to other countries regions. With the business expansion, they are now looking for a team of regulatory affairs, both RA Manager and Executives.

• Self development: Able to enhance skills and regional exposure in product registration of medical devices.
• Professional Growth and Learning: The company values your growth and development. With access to a supportive work environment, training, and career advancement opportunities, you can expand your skills and expertise while building a fulfilling career in the medical device industry.
• Quality-Driven Focus: The company places a strong emphasis on quality and efficacy. By joining the team, you\'ll be part of an organisation that prioritises delivering high-quality products to meet the needs.

Michael Page