What are the responsibilities and job description for the Quality and Regulatory Specialist position at Top Quality Recruitment (TQR)?
Employment Type: Full-time
Available Positions: 1
Location: On-Site
Application Deadline: May 13, 2026
Summary
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 finalize MDR reports.
- Document control, clerical support, data entry, filing, scanning, copying, printing, organizing 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-organized 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.
Educations & 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.
Are you looking for your next opportunity? We can help.
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.
Are you looking to hire? Get started here:
https://www.topqualityrecruitment.com/fill-a-position/
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We thank all applicants for their interest and appreciate the time and effort involved; however, due to the large volume of resumes received only those candidates selected for an interview will be contacted. Please attached your resume to your application.
Job ID: 8275