APAC RAQA Senior Manager

MicroPort; Singapore; Vor Ort; SGD 180.000 - 260.000; Vollzeit

Zusammenfassung

MicroPort is seeking an experienced RAQA Manager for APAC to oversee regulatory affairs and quality assurance across the region, ensuring compliance with local requirements and MicroPort quality systems.

This role acts as a key liaison between APAC markets, global headquarters, and cross‑functional teams, supporting market access, product lifecycle management, and quality compliance. The position requires hands‑on regulatory knowledge and quality management expertise across multiple countries.

Qualifikationen

• 8+ years of experience in Regulatory Affairs and/or Quality Assurance within the medical device industry.
• Strong experience working across multiple APAC regulatory environments.
• Proven experience in product registration, regulatory submissions, and lifecycle management.
• Experience supporting QMS and audit activities.
• Exposure to regional / multinational organisations is preferred.

Aufgaben

• Develop and execute regulatory strategies for product registration, approval, and lifecycle maintenance across APAC markets.
• Lead and manage product registrations, renewals, and variations, ensuring compliance with local regulatory requirements.
• Monitor regulatory changes and assess their impact on products and business operations.
• Serve as the key contact with local regulatory authorities, notified bodies, and partners.
• Support regulatory submissions and documentation, including technical files and product dossiers.
• Provide regulatory guidance to internal stakeholders on market access and compliance requirements.
• Ensure implementation and maintenance of Quality Management System (QMS) in line with ISO 13485 and applicable regulations.
• Support internal and external audits, including regulatory inspections and certification audits.
• Manage non-conformities, CAPA processes, and quality investigations.
• Oversee complaint handling, vigilance reporting, and post‑market surveillance activities.
• Ensure product and process compliance with quality standards and regulatory requirements.
• Act as the regional RAQA focal point, working closely with local distributors, partners, and affiliates.
• Provide operational support for product launches and market expansions across APAC.
• Coordinate cross‑functional activities with Commercial, Supply Chain, Clinical, and HQ teams.
• Drive consistency and alignment of RAQA processes across markets.
• Identify and mitigate regulatory and quality risks across the region.
• Support implementation of risk management frameworks (e.g., ISO 14971).
• Ensure adherence to global compliance policies and internal control systems.

Kenntnisse

Regulatory Affairs

Quality Assurance

APAC region

Regulatory Submissions

ISO 13485

ISO 14971

Lifecycle Management

Audits & CAPA

Ausbildung

Bachelor’s degree or above in Biomedical Engineering, Life Sciences, Regulatory Affairs, or related field

Jobbeschreibung

The RAQA Manager, APAC is responsible for overseeing regulatory affairs and quality assurance activities across the Asia‑Pacific region, ensuring full compliance with local regulatory requirements, global standards, and MicroPort quality systems.

This role acts as a key liaison between APAC markets, global headquarters, and cross‑functional teams, supporting market access, product lifecycle management, and quality compliance. The position requires a hands‑on professional with strong regulatory knowledge, quality management expertise, and the ability to operate across multiple countries and regulatory environments.

Job Responsibilities

Regulatory Affairs

• Develop and execute regulatory strategies for product registration, approval, and lifecycle maintenance across APAC markets
• Lead and manage product registrations, renewals, and variations, ensuring compliance with local regulatory requirements
• Monitor regulatory changes and assess their impact on products and business operations
• Serve as the key contact with local regulatory authorities, notified bodies, and partners
• Support regulatory submissions and documentation, including technical files and product dossiers
• Provide regulatory guidance to internal stakeholders on market access and compliance requirements

Quality Assurance

• Ensure implementation and maintenance of Quality Management System (QMS) in line with ISO 13485 and applicable regulations
• Support internal and external audits, including regulatory inspections and certification audits
• Manage non-conformities, CAPA processes, and quality investigations
• Oversee complaint handling, vigilance reporting, and post‑market surveillance activities
• Ensure product and process compliance with quality standards and regulatory requirements

APAC Regional Support & Coordination

• Act as the regional RAQA focal point, working closely with local distributors, partners, and affiliates
• Provide operational support for product launches and market expansions across APAC
• Coordinate cross‑functional activities with Commercial, Supply Chain, Clinical, and HQ teams
• Drive consistency and alignment of RAQA processes across markets
• Identify and mitigate regulatory and quality risks across the region
• Support implementation of risk management frameworks (e.g., ISO 14971)
• Ensure adherence to global compliance policies and internal control systems

Qualifications

Education

Bachelor’s degree or above in Biomedical Engineering, Life Sciences, Regulatory Affairs, or related field

Experience

• 8+ years of experience in Regulatory Affairs and/or Quality Assurance within the medical device industry
• Strong experience working across multiple APAC regulatory environments
• Proven experience in product registration, regulatory submissions, and lifecycle management
• Experience supporting QMS and audit activities
• Exposure to regional / multinational organisations is preferred

Professional Qualifications

• Knowledge of ISO 13485, ISO 14971, and relevant APAC medical device regulations
• Regulatory certifications or training are a plus