Executive - QA (Regulatory & Complaint Support)

Overview

Responsible for ensuring company and manufactured products comply with regulatory and statutory requirements. Supports regulatory submissions for multiple international markets (Canada, China, Korea, EU, USA, etc.). Assists the Manager in coordinating and documenting customer complaint investigations to ensure timely resolution and compliance with internal procedures.

Responsibilities

• Document Management & Support: Assist in preparing and managing declarations (chemical, equivalency, shelf life, conformity), MSDS, technical specifications, IFUs, and product specifications (new/revised). Support questionnaires, tenders, and internal/external lab testing coordination. Review/validate labelling artwork per regulatory requirements (UDI, MDR, PPE, EU Rep). Update EU compliance records (MDSS, SATRA) and maintain 510(k), FDA FURLS, EUDAMED listings. Support global registrations for multiple markets under supervision. Coordinate review of Quality Ag...