Job Description

Job descriptions for medical device registration can vary depending on the specific organization and the level of responsibility. Position: Medical Device Registration Specialist Role Summary: The Medical Device Registration Specialist is responsible for ensuring compliance with regulatory requirements and managing the registration process for medical devices. This role involves coordinating with cross-functional teams, interacting with regulatory authorities, and maintaining accurate documentation to support the registration of medical devices. Key Responsibilities: 1. Regulatory Compliance: \xe2\x80\xa2 Stay updated with relevant regulations, guidelines, and standards related to medical device registration. \xe2\x80\xa2 Interpret and apply regulatory requirements to ensure compliance during the registration process. \xe2\x80\xa2 Conduct risk assessments and gap analyses to identify compliance issues and propose corrective actions. 2. Registration Process Management: \xe2\x80\xa2 Develop and implement strategies for efficient and timely registration of medical devices. \xe2\x80\xa2 Prepare and compile necessary documentation, including technical files, design dossiers, and quality system documentation. \xe2\x80\xa2 Coordinate and collaborate with internal teams, such as research and development, quality assurance, and clinical affairs, to gather required information. \xe2\x80\xa2 Review and ensure accuracy of registration applications, including labeling, product specifications, and manufacturing processes. 3. Regulatory Authority Interaction: \xe2\x80\xa2 Communicate and collaborate with regulatory authorities to obtain necessary approvals and resolve any registration-related queries. \xe2\x80\xa2 Prepare and submit registration dossiers and responses to requests for additional information. \xe2\x80\xa2 Track and monitor the progress of registration applications and maintain open lines of communication with regulatory agencies. 4. Documentation and Recordkeeping: \xe2\x80\xa2 Maintain accurate and up-to-date records of all registration activities, correspondence, and regulatory submissions. \xe2\x80\xa2 Develop and maintain document control systems to manage regulatory documentation. \xe2\x80\xa2 Prepare reports and summaries of registration status, metrics, and regulatory compliance for internal stakeholders. 5. Quality Management System Support: \xe2\x80\xa2 Contribute to the development, implementation, and maintenance of the quality management system to ensure regulatory compliance. \xe2\x80\xa2 Participate in internal and external audits related to medical device registration and regulatory compliance. Qualifications and Skills: \xe2\x80\xa2 Bachelor\'s degree in a scientific discipline or a related field (e.g., biomedical engineering, regulatory affairs). \xe2\x80\xa2 In-depth knowledge of medical device regulations and standards (e.g., FDA, EU MDR, ISO 13485). \xe2\x80\xa2 Experience in medical device registration, regulatory affairs, or a related field within the healthcare industry. \xe2\x80\xa2 Strong understanding of the medical device development lifecycle and quality management systems. \xe2\x80\xa2 Excellent written and verbal communication skills to effectively interact with internal teams and regulatory authorities. \xe2\x80\xa2 Detail-oriented with exceptional organizational and project management abilities. \xe2\x80\xa2 Analytical thinking and problem-solving skills to assess regulatory requirements and propose appropriate solutions. \xe2\x80\xa2 Ability to work independently, prioritize tasks, and meet deadlines in a dynamic regulatory environment.
Bio Universal Med Sdn Bhd is a company registered with the Medical Device Authority (MDA), Suruhanjaya Syarikat Malaysia and the Malaysia External Trade Development Corporation (MATRADE). The company deals with the supply of medical disposable products for the Government, Public & Private Hospitals, Pharmacies, General Practitioners and Private Agencies. The company will provide all the necessary support and assistance to our clients as may be required in relation to any matter involving our products. The company strives to provide the public with best quality and service at affordable prices. The company has an experienced management team well versed with governmental requirements and procedures pertaining to the supply of such products. The company is an Appointed Dealer from Local Manufacturers and Authorised Representative from Overseas Principal to import, distribute and sell the medical device products. Vision: \xe2\x80\xa2 To become the leading supplier of quality single use medical disposable. Missions: \xe2\x80\xa2 Satisfying customer needs by supplying quality and safe healthcare products. \xe2\x80\xa2 To encourage teamwork and participate in the decision-making process. \xe2\x80\xa2 To establish an efficient organization with motivated employees. \xe2\x80\xa2 To maintain success in the local market as well as expansion in global markets.
Bachelor\'s or Equivalent