Senior QA and RA Specialist

2 days ago

Singapore beBeeRegulatory Full time

Job Description:

Support our Quality Assurance and Regulatory Affairs functions as a QA/RA Specialist.

  • Ensure compliance with ISO13485, cGMP, and international regulatory requirements.
  • Play a key role in product registrations, audits, and maintaining the company's Quality Management System (QMS).

Key Responsibilities:

Quality Assurance (QA)

  • Implement and maintain QMS in compliance with ISO13485, FDA 21 CFR, EU MDR, and other applicable regulations.
  • Support document control, management reviews, audits (internal & external), CAPA, product complaints, and training.
  • Act as independent reviewer for validation protocols (IQ/OQ/PQ) and reports.
  • Communicate regulatory or quality requirement changes to relevant departments and ensure timely implementation.

Regulatory Affairs (RA)

  • Assist with product registration, renewal, and change notifications across global markets.
  • Liaise with regulatory agencies, consultants, and authorized representatives to track and incorporate updated requirements into QMS.
  • Prepare and maintain dossiers and technical documents for regulatory submissions.
  • Maintain and update a listing of registered products and manage renewals.
  • Support post-market surveillance, recalls, and audit preparation with customers and regulatory bodies.

Requirements:

  • Degree in Engineering (Mechanical) or Life Sciences (Pharmacy, Biology, Chemistry).
  • Diploma holders with 3+ years of relevant experience will be considered.
  • Knowledge of ISO13485, cGMP, and international regulatory frameworks.
  • Detail-oriented, proactive, and able to work independently.

What We Offer:

  • Stable career with growth opportunities.
  • Exposure to international quality and regulatory frameworks.
  • Variable bonus and employee benefits.

  • QA/RA Specialist

    4 weeks ago

    Singapore MCI CAREER SERVICES PTE. LTD. Full time

    Job Highlight Location : Tuas Crescent MRT Salary: Up to S$3,200 + Variable Bonus Working Hours: 7.45 a.m. – 4.45 p.m. (Monday – Friday) About the Role Our client is looking for a motivated QA/RA Specialist to join our team. In this role, you will support Quality Assurance and Regulatory Affairs functions, ensuring compliance with ISO13485, cGMP, and...

  • Senior QA and RA Specialist

    4 days ago

    Singapore beBeeRegulatory Full time $2,900 - $3,200

    Job Description:Support our Quality Assurance and Regulatory Affairs functions as a QA/RA Specialist.Ensure compliance with ISO13485, cGMP, and international regulatory requirements.Play a key role in product registrations, audits, and maintaining the company's Quality Management System (QMS).Key Responsibilities:Quality Assurance (QA)Implement and maintain...

  • QA/RA Specialist

    1 week ago

    Singapore MCI CAREER SERVICES PTE. LTD. Full time

    Roles & Responsibilities Job Highlight Location : Tuas Crescent MRT Salary: Up to S$3,200 + Variable Bonus Working Hours: 7.45 a.m. – 4.45 p.m. (Monday – Friday) About the Role Our client is looking for a motivated QA/RA Specialist to join our team. In this role, you will support Quality Assurance and Regulatory Affairs functions, ensuring...

  • Senior QA and RA Specialist

    2 days ago

    Singapore beBeeRegulatory Full time

    Job Description: Support our Quality Assurance and Regulatory Affairs functions as a QA/RA Specialist. Ensure compliance with ISO13485, cGMP, and international regulatory requirements. Play a key role in product registrations, audits, and maintaining the company's Quality Management System (QMS). Key Responsibilities: Quality Assurance (QA) ...

  • Ra&qa Executive

    2 weeks ago

    Singapore INTEGRITY PARTNERS PTE. LTD. Full time

    **THE ROLE**: The RA&QA Executive will be responsible for regulatory compliance of IVD devices and related products according to relevant medical device regulations. Also, the RA&QA Executive will also be acting as a cross-department liaison with internal and external stakeholders, including distributors in the ASEAN region. **OVERVIEW OF KEY...

  • QA/RA Specialist

    2 days ago

    Singapore MCI CAREER SERVICES PTE. LTD. Full time

    Job Highlight Location : Tuas Crescent MRT Salary: Up to S$3,200 + Variable Bonus Working Hours: 7.45 a.m. – 4.45 p.m. (Monday – Friday) About the Role Our client is looking for a motivated QA/RA Specialist to join our team. In this role, you will support Quality Assurance and Regulatory Affairs functions, ensuring compliance with ISO13485,...

  • Ra Specialist

    4 days ago

    Singapore Ethos BeathChapman Full time

    **Job Details**: **Location** Singapore **Salary** Competitive Salary **Job Type** Permanent **Ref** BH-176576 **Contact** Piers Atkinson- **Posted** about 2 hours ago - Look for an RA Specialist working as part of a small team focusing on regulatory requirements across APAC. This role offers a great learning curve for people earlier in their...

  • QA Production Compliance Specialist

    3 days ago

    Singapore VENTAS BIO PTE. LTD. Full time

    Join Ventas Bio, a trailblazer in the realm of regenerative medicine. We are more than just a medical technology company. We are innovators dedicated to healing bodies through advanced science. Our team, driven by the "Think Biology" ethos, relentlessly pursues new paths in tissue and bone regeneration and wound healing. At Ventas Bio, we're not just...

  • QA/ra Associate Specialist

    2 days ago

    Singapore Zimmer Biomet Full time

    **Requisition Number**: APAC05208 **Employment Type**: Full-time **Location**: Singapore **Principal Duties and Responsibilities**: Regulatory Affairs - Work closely with regional RA & Global to drive reduction of registration cycle time through Speed to Market initiatives. - Define and implement product registration approval strategies and plans. -...

  • QA/ra Associate Specialist

    2 days ago

    Singapore Zimmer Biomet Full time

    -Requisition Number APAC05208 Employment Type Full-time Location Singapore **Job Summary**: **Principal Duties and Responsibilities**: - Regulatory Affairs- Work closely with regional RA & Global to drive reduction of registration cycle time through Speed to Market initiatives. - Define and implement product registration approval strategies and plans. -...