Senior /regulatory Affairs Executive [device

Full awareness of local Health Products and Medical Device Act and their regulations relevant to the business through regularly checking HSA websites and attending HSA briefings; - Communicate changes and new requirements to management; - Meet, discuss and negotiate with HSA regulators on matters pertaining to product registrations; - Have working knowledge...

The Regulatory Affairs Specialist (MD) is a member of the local Regulatory Affairs department, responsible for activities to support and actively contributing to the regulatory compliance of medical devices products under their responsibility. - The Regulatory Affairs Specialist (MD) will be a member of the local regulatory affairs department within Johnson...

**THE OPPORTUNITY**: An esteemed **Medical Devices Company **is currently seeking a highly capable **Regulatory Affairs Specialist **to join their team. The successful incumbent will be tasked with the development and implementation of efficient regulatory strategies and processes, ensuring timely product registration, life cycle management, and post-market...

Essential Duties and Responsibilities:Regulatory Affairs Responsibilities:Assist in authoring, editing and reviewing of technical documents e.g. medical device verification & validation documents, standard operating procedures, risk management plans and reports for medical devices.Assist in the preparation, review and compilation of technical dossiers for...

Resuscitation Job Summary: This position will report to the Senior Manager, Regulatory Affairs Regional Leader, JAPAC. The Primary role of the Specialist within the company is to assist Regulatory Affairs department to implement and administrate of organization activities to support and ensure regulatory compliance. At ZOLL, we're passionate about improving...

**Location**: Singapore Job highlights The opportunity to make a real impact. Immediately Interview Work in a fast-paced and exciting environment Our client's innovations are transforming healthcare. They need an experienced Senior Regulatory Affairs. You will lead Southeast Asia regulatory initiatives to ensure their varied pharmaceuticals and medical...

**Job Description Summary**: We are seeking a detail-oriented and motivated intern to support the Regulatory Affairs team with UDI (Unique Device Identification) data entry activities for Australia and Singapore. This role is ideal for students or recent graduates interested in regulatory affairs, data management, or the medical device industry. **Key...

**Headquartered: US**: - **Position: Regional**: - **Product Porfolio: Medical Devices**: - **Reporting to: Regulatory Affairs Manager** **MAIN RESPONSIBILITIES**: - Facilitate regulatory affairs activities related to regulatory submissions, annual reports, registrations, and listings while ensuring compliance with relevant medical device regulations,...

**ESSENTIAL JOB DUTIES AND RESPONSIBILITIES**: - Provide Subject Matter Guidance in all aspects of Medical Device, In Vitro Diagnostic (IVD), Artificial Intelligence Medical Device, Standalone medical device software submissions etc. - Assist head of regulatory services in assuming primary or secondary regulatory responsibility for assigned projects by...

**Responsibilities**: - Prepare product technical dossiers for regulatory submission - Understand labelling requirements in multiple region and manage artwork used in product packaging - Liaise with relevant parties to resolve product registration and regulatory issues - Maintain document control of technical file, quality procedures and work instructions...