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Quality Control jobs in Singapore
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Global Procurement Director - Excellence & Operations
Asahi
Singapore
On-site
SGD 80,000 - 120,000
26 days ago
SVP, Senior ITSM Specialist, EASRE, Group Technology
300005 Chief Executive's Office_00002555
Singapore
On-site
SGD 120,000 - 160,000
26 days ago
Discover more opportunities than anywhere else. Find more jobs nowVice President, Regional Avaloq Product Owner / Business Lead, Consumer Banking Group
DBS
Singapore
On-site
SGD 120,000 - 150,000
26 days ago
Tech Apprenticeship: Banking Systems, Mentored & Hands-On
DBS
Singapore
On-site
SGD 20,000 - 60,000
26 days ago
Connect with headhunters to apply for similar jobsGuest Experience & Quality Excellence Manager
Pullman Hotels & Resorts
Singapore
On-site
SGD 60,000 - 80,000
26 days ago
AVP, Oracle Database Engineer (Avaloq), Consumer Banking Group Technology, Group Technology
300005 Chief Executive's Office_00002555
Singapore
On-site
SGD 90,000 - 130,000
26 days ago
Client Success & Program Delivery Lead
VISIONTECH PTE. LTD.
Singapore
On-site
SGD 80,000 - 100,000
26 days ago
VP / AVP, Regional Treasures Segment Manager, Consumer Banking Group
DBS
Singapore
On-site
SGD 120,000 - 180,000
26 days ago
Principal / Senior Mechanical Engineer (Hospital and Services Planning), EGH Planning Office
Singapore National Eye Centre
Singapore
On-site
SGD 70,000 - 90,000
26 days ago
Demand Planning Manager (1 Year Contract)
the LEGO Group
Singapore
On-site
SGD 100,000 - 125,000
26 days ago
Assistant Director (Data Policy & Governance)
DIS-DOTC
Singapore
On-site
SGD 80,000 - 100,000
26 days ago
Bank PMO Trainee – GRIT Programme (Onsite Singapore)
Monee
Singapore
On-site
SGD 60,000 - 80,000
26 days ago
Project Asset Care Lead (2 years contract)
GlaxoSmithKline
Singapore
On-site
SGD 80,000 - 120,000
26 days ago
Regulatory Affairs Executive
ABIORES PTE. LTD.
Singapore
On-site
SGD 60,000 - 80,000
Full time
26 days ago
Job summary
A medical device company based in Singapore is seeking a Regulatory Affairs Specialist to support product registration and compliance with FDA regulations. The role requires a Bachelor’s degree in a relevant field and at least 2 years of hands-on experience with FDA submissions. Key responsibilities include coordinating with CROs and regulatory authorities, project management, and fostering relationships with industry leaders. The ideal candidate is detail-oriented and willing to travel to the United States for stakeholder engagement.
Qualifications
- Minimum 2 years of experience with the FDA on medical device registration.
- Skills in planning, execution, and timely communication.
- Proactive work ethic with a strong level of accountability.
Responsibilities
- Support product registration activities and coordinate with CROs.
- Act as the expert on medical device regulatory requirements.
- Interface with global regulatory authorities and track submission progress.
Skills
Project management
Technical writing
Interpersonal skills
Detail-oriented
Education
Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Engineering
Job description
Job Responsibilities:
- Support product registration activities, including the preparation of registration dossiers, performance evaluation study design, and coordination with CROs (Clinical Research Organizations).
- Act as the subject matter expert on medical device regulatory requirements, with a particular focus on FDA regulations. Stay current with relevant laws and ensure internal practices remain compliant.
- Interface with global regulatory authorities such as the FDA, Health Sciences Authority (HSA), and Medical Device Authority (MDA). Track submission progress and manage responses to queries or objections during the review process.
- Participate in clinical verification, product testing, data collection, and ongoing tracking activities to support both regulatory submissions and product performance validation.
- Prepare and submit scientific and technical documentation for special projects or novel product classifications.
- Foster professional relationships with regulatory bodies, third-party experts, and key opinion leaders to strengthen regulatory pathways and advocacy.
- Collaborate cross-functionally with internal teams (e.g., R&D, Clinical, Quality Assurance) to align regulatory strategy with overall business goals.
- Undertake any additional regulatory tasks or projects as assigned by the management team.
Job Requirements:
- A Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Engineering, or a related discipline.
- Minimum 2 years of hands‑on experience working with the FDA on medical device registration, submissions (e.g., 510(k), IDE), or related regulatory pathways.
- Demonstrated skills in project management, planning, execution, and timely communication. Strong presentation and technical writing abilities are essential.
- Enthusiastic, proactive, and professional work ethic with a high level of accountability. Strong interpersonal skills and the ability to collaborate across teams.
- Detail‑oriented with a high degree of responsibility. Able to handle regulatory pressure and manage tight timelines effectively.
- Willing and able to travel to the United States for one month every six months as part of regulatory project and stakeholder engagement needs.
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.