Executive recruitment company Monroe Consulting Group Malaysia is recruiting on behalf of a leading MNC company in medical devices. Our distinguished client is looking for an ambitious and experienced professional for the role of Regulatory Affairs Coordinator. The opportunity is a remote role based in Malaysia. This role provides guidance, assessment, oversight and maintenance of regulatory, quality and applicable standards and guidance documents information related to FDA, ISO, GMP and additional standards used in the development and implementation of regulatory strategies to support the achievement of business objectives while coordinating activities with internal team members and external parties such as regulatory bodies, regulatory consultants and the like to obtain and maintain regulatory filings, registrations and compliance.
Job Responsibilities:
* This role reports to the Global Director of Regulatory Affairs.
* Monitoring standards, regulations, guidance documents documentation, and change control processes to assure policies, procedures and practices are in compliance with appropriate regulatory requirements.
* Provides analytical, interpretive and evaluative solutions to complex problems through specialized regulatory expertise based on an in-depth knowledge of technical and business practices.
* Defining, assessing and providing new and updates as necessary to ensure global regulatory compliance with FDA, Canadian, European and other agency regulations
* Manage division regulatory activities and serve as the direct liaison with regulatory agencies, as well as with other internal functional departments for new product development strategy.
* Serves as operations coordinator for all applicable standards
* Evaluate data trends to be used for quality compliance, regulatory filings, etc
* Ability to quickly interpret and apply Federal/International/State and local regulations and standards
* Effective communicator in a collaborative environment, achieving both internal and external customer confidence
* Ability to communicate with suppliers of components, raw materials, and equipment vendors to ensure that they are in compliance with their respective governing bodies
* Analyze complex questions regarding standards in the healthcare/medical device setting and effectively communicates resolutions
* Maintains appropriate relationships with foreign and domestic regulatory governmental agencies by serving as a liaison
* Active participation and support for all continuous improvement and SOP efforts which leads to increased productivity, profitability, and customer satisfaction in areas of responsibility
* Provides technical assistance and consultation to marketing, manufacturing, and customers regarding raw material selection, competitor product evaluation, and troubleshooting
Job Requirements:
* Bachelor's degree in biological sciences, microbiology chemistry or engineering required; Graduate studies in Regulatory Affairs preferred
* RAC certified professional and project management skills desirable
* Working knowledge of FDA, GMP, ISO, and GLP compliance procedures.
* 2+ years' experience in Regulatory Affairs in a medical device company
* Experience in dealing with FDA, Notified Bodies and other regulatory agencies
* Working knowledge of ISO and applicable International regulations, compliance and audit practices
* Intermediate level proficiency in Microsoft Office programs (Excel, PowerPoint, Word)
* Prudent and practical decision-making abilities, a team player, and can work independently without direct supervision
