QA/RA Manager

3 weeks ago

Singapore FATHOMX PTE. LTD. Full time
Roles & Responsibilities

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.

Tell employers what skills you have

CE marking
CAPA
FDA
Regulatory Compliance
Quality Management
Quality Assurance
Regulatory Affairs
ISO
TGA
Risk Management
Surveillance
Audits
Product Development
Regulatory Requirements
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