Specialist,Commercial Quality & Regulatory Affairs Job Singapore,Quality Assurance

Position: Specialist, Commercial Quality & Regulatory Affairs at Beckman Coulter Diagnostics

Overview

The Specialist, Commercial Quality & Regulatory Affairs will prepare regulatory submissions and interact with regulatory agencies and health authorities to obtain and maintain product approvals. The role supports regulatory activities for IVD devices, coordinates documentation for submissions, and ensures compliance across the product lifecycle.

Key Responsibilities

Lead pre‑market and post‑market regulatory activities for IVD devices, including preparation and submission of technical documentation, regulatory applications, change notifications, renewals, and responses to regulatory bodies and partners.
Maintain and manage regulatory intelligence and compliance at local, regional, and global levels, ensuring adherence to applicable regulations throughout the product lifecycle.
Oversee quality management processes and continuous improvement, including compliance operations, audits, CAPA, distributor and warehouse oversight, and act as Quality Management Representative (QMR) when required.
Represent regulatory affairs on project core teams and coordinate document packages for regulatory submissions from all areas of the company, as well as for internal audits and inspections.
Compile all materials required for submissions, license renewals, and annual registrations; recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
Keep abreast of new or updated regulatory policies and issued guidance; recommend updates to internal processes as necessary.

Qualifications

Bachelor’s degree with 2+ years of relevant experience, or a medical device certificate with 2 years of experience, or 3+ years of experience in medical devices or a related industry.
Understanding of regulatory affairs concepts and familiarity with regulations/guidelines governing the development of diagnostic products.
Ability to prioritize, multitask, and organize work in a fast‑paced environment, demonstrating flexibility and adaptability to meet business needs.
Preferred:
Certified audit certificate for ISO
13485, ISO
9001, or GMP support for local audits.
Preferred:
Experience performing in‑country IVD/MD submissions with authority in a Southeast Asian country.

Travel &

Physical Requirements

Travel: 10% travel expected. The role requires a motor vehicle record and a physical environment that allows for safe work practices.

Remote Work

This position is eligible for a remote work arrangement. Eligible roles can work remotely from their home location, with additional details provided during the interview process.

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