Digital Health Quality Assurance and Regulatory Affairs Manager

2 days ago


Singapore MyCareersFuture Full time

Job Summary

We are seeking a highly skilled Digital Health Quality Assurance and Regulatory Affairs Manager to join our team at MyCareersFuture. As a key member of our organization, you will be responsible for ensuring the quality and regulatory compliance of our digital health products.

Key Responsibilities:

  • Quality Management System (QMS):
    • Develop, implement, and maintain the QMS in accordance with ISO 13485 and other relevant standards.
    • Lead internal and external audits, ensuring compliance with regulatory and company standards.
    • Manage CAPA (Corrective and Preventive Actions) processes to address non-conformities and improve system effectiveness.
    • Oversee document control, ensuring that all quality documentation is accurate, up-to-date, and properly maintained.
    • Provide training to staff on QMS procedures and regulatory requirements.
  • Regulatory Affairs:
    • Develop and execute regulatory strategies to obtain and maintain product approvals in multiple markets, including but not limited to the US (FDA), EU (MDR), ASEAN, South Asia, and China/Taiwan/Hong Kong (HSA, TGA, PMDA, NMPA).
    • Prepare and submit regulatory filings, including 510(k), CE marking, and other market-specific submissions.
    • Monitor changes in regulatory requirements and communicate their impact to the organization.
    • Liaise with regulatory authorities and notified bodies as necessary to ensure timely product approvals and renewals.
    • Maintain regulatory compliance for all marketed products, including post-market surveillance and reporting.
  • Cross-Functional Collaboration:
    • Work closely with R&D, Clinical, and Product Development teams to ensure compliance with regulatory requirements throughout the product lifecycle.
    • Support the development of clinical evaluation plans and reports.
    • Participate in risk management activities, ensuring that potential risks are identified and mitigated effectively.
    • Provide regulatory guidance to cross-functional teams, ensuring alignment with regulatory standards.
  • Continuous Improvement:
    • Drive continuous improvement initiatives within the QA/RA department to enhance processes, efficiency, and compliance.
    • Stay updated on industry trends, regulatory changes, and best practices to ensure the company's compliance programs remain current and effective.
    • Participate in professional development opportunities to enhance expertise in quality and regulatory affairs.

Qualifications:

  • Bachelor's degree in a relevant scientific or engineering discipline. Advanced degree preferred.
  • Minimum of 1 year of experience in quality assurance and regulatory affairs within the medical device or digital health industry.
  • In-depth knowledge of ISO 13485, FDA regulations (21 CFR Part 820), MDR, and other international regulatory standards.
  • Proven track record of successful regulatory submissions and product approvals in multiple markets, including the US, EU, ASEAN, South Asia, and China/Taiwan/Hong Kong.
  • Strong understanding of risk management principles (ISO 14971).
  • Excellent organizational, analytical, and problem-solving skills.
  • Strong communication and interpersonal skills, with the ability to work effectively in a cross-functional team environment.
  • Certification in regulatory affairs (e.g., RAC) is a plus.

What We Offer:

  • Competitive salary and benefits package.
  • Opportunity to work in a fast-paced, innovative environment with a focus on cutting-edge technology.
  • Professional development and career growth opportunities.
  • Collaborative and supportive team culture.

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