About the Role
The Quality and Regulatory Specialist will manage and coordinate tasks associated with product and procedure compliance and support the quality management system in accordance with relevant regulatory requirements of medical devices.
Key Activities
Start and oversee the comprehensive complaint handling process, covering intake, product returns, investigation, customer responses, and collaboration with various stakeholders. Ensure complaints are escalated based on severity and regulatory deadlines, and finalise MDR reports.
Document control, clerical support, data entry, filing, scanning, copying, printing, organising files, etc.
Revise SOPs, Forms, and quality documents in accordance with domestic regulations and current GMP practices.
Interface with suppliers to manage the maintenance of the Approved Supplier List.
Lead internal audits and support regulatory inspections.
Provide a review of regulatory submission documents.
Writing and executing equipment validation(s).
Work with warehouse and logistics teams to ensure GMP-compliant environmental control and product handling.
Maintain clear and well-organised documentation for all quality and regulatory activities.
Manage quality-related data, quality agreements, and other relevant documents.
Provide support on other RA/QA projects and perform other duties as assigned.
Know and conduct business in accordance with the Company’s quality programs and standards.
Preferred Skills
Computer-literate, particularly with programs such as Outlook, Excel, Word, Access, and Adobe Acrobat.
Strong multitasking abilities and successfully coordinates and manages activities with intersecting relationships, as well as those that may be unrelated.
Education and Experience
A bachelor's degree in a scientific or technical discipline, or an associate’s degree, with 3-5 years of industry experience and an understanding of FDA CGMPs, FDA QMSR, ISO 13485, and 510(k) preferred.
Experience with complaints, field actions, trend analysis, and regulatory documents.
About Us
Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible.
TQR is an equal-opportunity employer that encourages diversity. We will consider all applications.
Accommodation for applicants with disabilities is available upon request.
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