Regulatory Engineer

Job Description - Regulatory Affairs Specialist
• Support development, preparation, & submission of technical files & regulatory documentation, 
including 510(k) submissions, APAC regulatory submissions, US FDA and EU submissions, pre submissions, and product registration dossiers for Class I, II, & III medical devices, in compliance 
with FDA, EU MDR, regulatory requirements, ISO 13485, and global regulatory requirements.
• Managed documentation for manufacturing line transfer activities and quality assurance, including 
the preparation and submission of adverse event reports, product safety evaluations, and regulatory 
impact assessments related to onmarket product changes, in compliance with regulatory 
requirements and facilitated acquisition of approvals.
• Reviewed and approved product labels, promotional materials, & packaging, managed regulatory 
number updates, product management, and state manufacturing licenses, to ensure compliance 
with FDA and ISO 13485 requirements. and quality enhancement throughout the line transfer 
process.
• Managed regulatory operations, including planning, preparation, assembly, & review of regulatory 
submissions, maintained regulatory databases (including Sharepoint), managed document control 
systems for FDA filings & market entry processes.
• Support preparation of regulatory filings such as 510(k) and instrument/software submissions, 
supported product release processes, reviewed protocols & reports, and engineering drawings in 
alignment with FDA submission requirements, and managing clinical investigations.
• Collaborated with QMS teams, supported audits and ensured submissions comply with relevant 
quality systems regulations, and ensured alignment of regulatory processes regulatory approvals and 
global standards, including EU MDR, ISO 13485 and FDA and APAC standards.
• Support documentation for the proposed changes to products and manufacturing processes, 
managed modifications in technical files, regulatory databases, & distributed documents, ensuring 
regulatory submissions reflect these changes. 
• Worked with cross-functional teams, including engineering, quality, and manufacturing, to support 
manufacturing line transfers, regulatory submissions, and product release activities. 
• Support documentation including 510(k) and PMA applications, Technical Files, and filings for 
product approvals, clearances, registrations, and licenses, and handled changes to existing ones, 
utilized SAP for enterprise resource planning and regulatory compliance management.
• Supported risk management processes to identify, assess, and mitigate regulatory risks associated 
with product development, manufacturing, and commercialization activities.
• Supported to create and manage Technical Files in accordance with IVDR regulations, collaborating 
with international colleagues to establish design dossiers for new product development and design 
changes tailored to specific markets.
Desired:
• Line transfer experience
• Experience 8-10 years in a regulated medical device environment
• Experience in APAC region regulatory policies