QMS & Regulatory Leader (ISO 13485, MDR, 21 CFR)

Overview The Quality Management System(QMS) and Regulatory Manager is responsible for the operational leadership and oversight of the organization's QMS and regulatory compliance functions. This individual serves as the QMS Management Representative in accordance with ISO 13485 and as the Person Responsible for Regulatory Compliance (PRRC) under the EU...

Our client is an exciting American medical devices startup in the field of pregnancy assisted birthing instruments. The company is rapidly expanding its operations here in Singapore and is looking for the position of Regulatory Affairs & QMS Manager. **Regulatory Affairs & QMS Manager.** Reporting to the Chief QARA Officer (Based in Singapore), you will be...

We are partnering with a emerging US-based medical equipment manufacturer focusing on innovations that reduce preventable harm and improve health outcomes for maternal and newborn health issues. As part of their expansion, they are looking to hire the following position for their Singapore team. **Quality Management System and Regulatory...

**Job description**: **Responsibilities** 1. Execute all regulatory activities including submission of new products or renewals until post-approval monitoring. 2. Understand the context of MDD/MDR, ISO 13485, AMDR, FDA 21 CFR Part 820, and other applicable regulations in the markets we served. 3. Compilation, review, coordination, submission, monitoring,...

We are a global leader in manufacturing of medical devices and deliver solutions to improve lives through today’s technology and future innovation. Due to business needs, we are now seeking for multiple experienced Regulatory Affairs executives to be part of our Regulatory Affairs team for ongoing transformation projects due to expansion. **Regulatory...

Key Responsibilities Support software design quality activities within global product development teams. Guide software verification and validation, including test methods, acceptance criteria, and documentation; ensure compliance with IEC 62304 . Lead software risk management activities and maintain risk files. Support software safety, effectiveness, and...

Job Title: Quality Assurance, Regulatory Affairs Manager Location: Tuas Working Days: Mon -Fri Working Hours: 7.45 AM-4.45 PM **Salary**: Basic up to $5000 Job Duties - Manage the quality management system and audit program ensuring compliance with the standards and regulatory requirements (cGMP, FDA 21 CFR Part 820, Part 210 & 211, EU MDR, and ISO...

**Qualifications & experience** - At least a Diploma in engineering or equivalent - Minimum of 3 years relevant experience in QA/QC/QMS. Experience in handling audits will be considered an asset. - Familiar with medical device standards such as ISO13485, ISO14971, ISO17025, GxP etc. - Equipped with excellent quality management knowledge and problem solving...

Skills, experience & qualifications required:Bachelor's degree in engineering discipline. Master's degree in engineering discipline preferred.5+ years in a quality or regulatory engineering role in the Medical Device field or highly regulated industry.Minimum 3+ years in a quality or regulatory role with focus on Software.Knowledge of and experience in IEC...

We are looking for a dedicated and experienced QC Microbiologist to oversee microbiological testing and ensure compliance with quality standards and regulatory requirements. The role involves supervising the QC Microbiology laboratory, guiding lab personnel, and ensuring sterility assurance in both testing and manufacturing environments. Key Responsibilities...