Job Description

Executive recruitment company Monroe Consulting Group Malaysia is recruiting on behalf of a leading company in medical devices. Our distinguished client is looking for an ambitious and experienced professional for the role of a Regulatory Affairs Specialist. This is a fully remote role based in Malaysia.

You will provide leadership in the development and implementation of regulatory strategies to support the achievement of business objectives while coordinating activities with internal team members and regulatory bodies.

Job Responsibilities:

• Assist R&D team in new product development and design control processes.
• Provide global regulatory assessments and determining regulatory pathways for new product development.
• Develop regulatory filing strategies and submission types for various types of regulatory approvals and clearance worldwide.
• Review and make final determinations for regulatory assessments of proposed changes to existing products.
• Read, review, interpret and stay up to date with regulations and publications regarding device and PPE products with primary focus on medical devices.
• Manage necessary corrective action for 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.
• Manage company regulation and documentation programs including development and distribution of standard operating procedures (SOPs), policies, and technical reports.
• Direct and review company self-audit and corrective action programs to ensure compliance with GMPs and Medical Device amendments.
• Maintain 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 leads to increased productivity, profitability, and customer satisfaction in areas of responsibility.
• Provide technical assistance and consultation to marketing, manufacturing, and customers regarding raw material selection, competitor product evaluation, and troubleshooting.
• Review and approve promotional materials for use in markets of responsibility.
• Provide assistance to contracts and sales with regards to product registration status and product characteristics needs for contracts.

• 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.
• 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.

Monroe Consulting