Director of Quality and Regulatory Affairs

Director of Quality and Regulatory Affairs

Department: Engineering/Quality

Classification: Manufacturing

Reports To: President

General Purpose

The Director of Quality & Regulatory Affairs owns, audits, and drives improvements within the Cork Medical Products (CMP) Quality Management System (QMS). He / She also manages the organizations' registrations, applications, readiness to enter new markets (domestic and international), and the company's compliance with standards and requirements in all the markets where Cork Medical Products engages in.

The Director of Quality and Regulatory Affairs reports to the President of Cork Medical.

Main Job Tasks and Responsibilities

Quality:

1. Drive all CMP certifications & registrations including, but not limited to, ISO 13485:2016, MDSAP, & 510K.

2. Manage all Quality Procedures & supporting documentation, with the different department managers within CMP.

3. Own the Document Management System (DMS) and provide recommendations for continuous improvement of document change control and document retention.

4. Audit all Quality Procedures & supporting documentation, as per schedule to ensure all policies & procedures are followed.

5. Audit all departments to ensure the QMS is being implemented appropriately.

6. Manage and Own the Corrective & Preventative Action (CAPA) System.

7. Support CMP Management for successful implementation and adherence to departmental procedures, and to make recommendations for continuous improvement.

8. Oversee all IQ, OQ, PQ activities at CMP.

9. Support 5S and Process Improvement within the organization

10. Support ERP/MRP/QMS software implementation.

Regulatory:

1. Manage Regulatory Updates, Renewals, Registrations, Submissions, 510K's or other as required.

2. Manage Medical Device Reporting to Regulatory Bodies

3. Maintain / Update PDAC System

4. Manage Device Labeling Requirements or Policies

5. Responsible for submission of all paperwork and/or documentation to government bodies or appropriate entities (domestic or foreign) that regulate medical devices and / or the different companies that CMP currently engages with, or will engage with, in the sale and / or distribution of its products or labeled products.

Education & Experience:

• Bachelor's Degree
• 10+ years of Quality and Regulatory Experience within the healthcare field
• Experience with managing a team
• Degree or Certification in Quality Systems or Industry Relevant Experience
• Project Management Experience Preferred

Key Competencies:

• Time Management
• Disciplined to Process and Procedure
• Self-Driven with Excellent Follow Through
• Analytical
• Personal Effectiveness in a Team Setting
• Effective Communicator
• Goal Oriented and Metric Driven
• Ethics - Respects Others, Inspires Trust of Others, Integrity in his/her Work, Upholds Organizational Values & Culture

Physical Demands

The physical demands & work environment factors described below are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions. Employees may be regularly required to use hands to handle or feel, reach with hands and arms, and talk or hear. Employees may be frequently required to sit or stand for periods of time. He/she may be required to push, pull, or lift objects up to 50 lbs. He/she may be required to use a ladder. Specific vision abilities required for this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust and focus.

Working Conditions - Includes Offices, Manufacturing Areas, Engineering Lab, Clean Room, and Warehouse Environment