[Hiring] Specialist, Commercial Regulatory Affairs @Danaher

Role Description

The Specialist, Commercial Quality & Regulatory Affairs will prepare regulatory submissions and interact with regulatory agencies/health authorities to obtain and maintain product approvals. This individual will represent RA on project core teams, coordinate and prepare document packages for regulatory submissions from all areas of the company as well as for internal audits and inspections. Compile all materials required in submissions, license renewal, and annual registrations. Recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Keep abreast of changes of new or updated regulatory policies and issued guidance.

This position reports to the Senior Manager, Commercial Quality & Regulatory Affairs and is part of the Center of Excellence located in Singapore and will be fully remote.

In this role, you will have the opportunity to:

• 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 acting as Quality Management Representative (QMR) when required.

Qualifications

• Bachelor’s degree with 2+ years of relevant experience or a certificate in medical devices with 2 years of experience or 3+ years of experience in the medical devices or a related industry.
• Understands Regulatory Affairs concepts and is familiar with regulations/guidelines governing the development of diagnostic products.
• Ability to prioritize, multitask, and organize work, succeed in a fast-paced environment with capability to be flexible and adaptable to meet business needs.

Requirements

• Ability to travel – 10%.

Benefits

• Comprehensive, competitive benefit programs that add value to our lives.
• Flexible, remote working arrangements for eligible roles.