Jobs in Bayan Lepas, Malaysia

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 Specialist. The opportunity is a remote role based in Malaysia. This role provides leadership 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:

• The Regulatory Affairs Specialist I reports to the Global Director of Regulatory Affairs.
• Responsible for monitoring design, 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 specialised regulatory expertise based on an in-depth knowledge of technical and business practices.
• Integrates and coordinate activities within clearly defined policies; helps develop and champion regulatory policies; relies on an ability to understand and motivate people without direct authority.
• Directing and coordinating activities 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.
• Oversees existing division products and obtains marketing approval for new/modified device applications.
• Assists the research and development team during new products development as well as assists in design control processes
• Provides global regulatory assessment and pathway(s)
• Obtains regulatory verification and confirms global strategy for new product development
• Determine regulatory filing strategies and submission types
• Develops, submits and coordinates with internal partners for filings of 510(k), IDE, PMA, ANDA, NDA, Technical Files and Design Dossiers for regulatory approval and clearance worldwide
• Reviews and makes final determinations for regulatory assessments of proposed changes to existing products
• Reads, reviews, interprets and keeps current with regulations and publications regarding device and PPE products with primary focus on medical devices
• Manages necessary corrective action in all areas of responsibility which leads to improved product quality, process efficiency, minimum corporate exposure, and maximum profitability
• Ensures that all necessary quality assurance, regulatory and validation procedures and policies are in place and up to date
• Manages company regulation and documentation programs including development and distribution of standard operating procedures (SOPs), policies, and technical reports
• Directs and reviews company self-audit and corrective action programs to ensure compliance with Good Manufacturing Practices (GMPs) and Medical Device amendments
• 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
• Reviews and approves promotional materials for use in markets of responsibility
• Provides assistance to contracts and sales with regards to product registration status and product characteristics needs for contracts

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
• 5+ 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
• 25% domestic travel