What are the responsibilities and job description for the Quality/Regulatory Specialist position at United Orthopedic Corporation?
Position Summary:
Under limited supervision, the Quality and Regulatory Specialist will manage and coordinate tasks associated with product, procedure compliance, and support the quality management system in accordance with relevant regulatory requirements of medical devices. Pay range would be 80-85K.
Initiate, update, and maintain complete and accurate regulatory compliance records including Complaint Tracking, CAPA, NCMR, RMA, Employee and New Hire Training logs, and marketing collateral, change logs, etc.
Provide data management and analysis with the ability to maintain great attention to detail and ability to multi-task.
Essential duties & responsibilities:
1. Initiate and manage the end-to-end complaint handling process, including intake, product returns, investigation, response to customers, and coordination with multiple stakeholders. Ensure complaints are escalated based on severity and regulatory timelines and complete MDR reports.
2. Document control, clerical support, data entry, filing, scanning, copying, printing, organizing files, etc.
3. Revise SOPs, Forms, and quality documents according to domestic regulations and to reflect current GMP practices.
4. Interface with Supplier’s to manage the maintenance of the Approved Supplier List.
5. Lead internal audits and support regulatory inspections.
6. Provide review of regulatory submission documents.
7. Writing and executing equipment validation(s).
8. Work with warehouse and logistics teams to ensure GMP compliant environmental control and product handling.
9. Maintain clear and well-organized documentation for all quality and regulatory activities.
10. Manage quality-related data, quality agreements, and other relevant documents.
11. Provide support on other RA/QA projects and perform other duties as assigned.
12. Know and conduct business in accordance with Company’s quality programs and standards.
13. Ensure safe practices within all areas of responsibility and throughout department.
Qualifications & experience:
1. A bachelor's degree in a scientific or technical discipline or associate’s degree with 3-5 years industry experience with an understanding of the FDA CGMP’s, FDA QMSR, ISO 13485, and 510(k) preferred.
2. Experience with complaints, field actions, trend analysis, and regulatory documents.
3. Computer literate, particularly with programs such as Outlook, Excel, Word, Access, Adobe Acrobat.
4. Strong multi-tasking abilities and successfully coordinates and manages activities that have intersecting relationships as well as activities that may be unrelated.
5. Excellent organizational and problem-solving abilities.
6. Strong work ethic and excellent people skills.
7. Makes decisions independently and can logically support recommendation ad decisions.
8. Strong analytical, communication, and cross-functional collaboration skills.
9. Applies knowledge, using strong conceptualization and abstract reasoning skills at a high level of problem identification and solution.
Physical Demands:
Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Must be able to sit for long periods of time.
Anticipated Travel: Less than 5%
Position Status: Full Time
Exempt Status: Exempt