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