Overview The Senior Regulatory Affairs (RA) Specialist supports the regulatory and product registration activities of the company globally including India, the Asia Pacific region, and the Middle East. This RA Specialist role requires a professional who will work closely with high priority regulatory activities such as CDSCO import licences and associated registrations activites in India, and product registration in Australia, Saudi Arabia, the United Arab Emirates, Singapore, Malaysia, the Philippines, and Thailand.
The RA Specialist will provide regulatory feedback in order to facilitate the launch of new products in the region and work with the design control teams to assess for regulatory impact of product changes. This RA Specialist will provide technical guidance to cross functional teams for submission preparation and interaction with regulatory agencies, in-country representatives, and distribution partners.
Responsibilities • Coordinate, author, and prepare regulatory submissions, including CDSCO import licence applications (Form MD-14/MD-15) and registration certificates, Australian TGA ARTG inclusion applications, Saudi FDA Medical Device Marketing Authorization (MDMA) applications, UAE MOHAP registrations, Singapore HSA product registrations, Malaysia MDA registrations, Philippine FDA Certificates of Product Registration, Thai FDA licences, and/or other documentation required for registration/licensure of products across the Asia Pacific and Middle East regions.
• Serve as a strategic business partner with business clients to proactively develop and implement practical, compliant regulatory plans, and delivering timely, effective business solutions to quality and regulatory issues. • Respond to regulatory agency requests and obtain necessary premarket approvals, registrations, and/or licences from health authorities across the India, Asia Pacific, and Middle East markets.
• Provide general support to the RA/QA department in regulatory-related matters. • Communicate with external agencies including CDSCO, TGA, SFDA, MOHAP, HSA, MDA, Philippine FDA, Thai FDA, and other health authorities with which the department interacts. • Manage in-country representatives, authorized representatives, importers, and distributor partners for regulatory matters, including the review of licence holder obligations and appointment documentation.
• Act as regulatory SME in product development cross-functional teams and other cross-functional activities as assigned. • Evaluate and approve proposed changes to products and controlled documents; develop, approve, and implement regional regulatory action plans based on these changes. • Maintain regulatory information in Rimsys, regulatory information management system, to ensure product selling status is in regulatory compliance with applicable local and regional country requirements.
• Review and approve labeling for compliance to standards, guidelines, regulations, and regulatory approvals/clearances, including country-specific labeling, language, and import documentation requirements. • Provide assistance and expertise during regulatoryinspections or audits. • Create and maintain regulatory documents and records, including summaries of such regulatory affairs activities and reports to management.
• Continue to enhance internal regulatory procedures and processes. Create and revise procedures as needed and provide training for these updates. • This position requires the ability to take initiative and effectively communicate cross-functionally, both externally and at all levels of the organization, across multiple time zones.Regular working hours with two hours of minimum overlap with the USA team • Uphold the Company’s core values of Integrity, Innovation, Accountability, and Teamwork.
• Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct. • It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management