What are the responsibilities and job description for the Director, Regulatory Affairs/Quality Operations position at Jobleads-US?
Director, Quality Operations/RA
Responsible for day-to-day Quality and Regulatory Operations for the company including the development and maintenance of a Quality Management System (QMS) supporting business operations and assuring compliance with existing and newly enacted regulatory requirements applicable to these operations.
Establish procedures to support and assure compliance with quality operations defined under 21 CFR 820, 806, 803, and 801, ISO 13485, and the Medical Device Single Audit Program (includes US and Health Canada) to which the company is engaged.
Key Responsibilities:
- Serve as the Management Representative
- Assure that management with executive responsibility understands the quality policy and objectives
- Establish and maintain procedures to control all documents supporting the QMS as well as business needs related to, but not limited to, Human Resources, Information Security Management, interactions with Health Care Providers (Federal Anti-Kickback Statute, False Claims Act, and alike)
- Support the establishment of and assure compliance with procedures for controlling purchased or received product, product traceability, applicable production and process controls including the inspection measuring of test equipment, acceptance activities, non-conforming product, product handling, storage, distribution, and installation
- Establish procedures for maintaining device master records where applicable to the operations to which the company is engaged
- Establish and assure compliance with procedures for receiving, reviewing, and evaluating complaints, acting in the capacity of the US complaint handling unit on behalf of the parent corporation.
- Support the establishment of and assure compliance with procedures for verifying servicing meets the specified requirements
- Establish and assure compliance with procedures for labeling provisions as applicable to the company's operations
- Establish and assure compliance with procedures for Medical Device reporting
- Establish and assure compliance with procedures for reports of corrections and removals
- Assure compliance with the requirements for establishment registration and listing
- Establish and enforce a policy for conduct during government inspections
- Provide quality/regulatory support to MRSZ as requested
- Maintain and adjust as needed company/MRSZ Quality Agreement to support new and/or modified operations
- Serve as a team member on the Information Security Management Security Committee supporting documentation, training, and all related ISO 27001 needs, including supporting compliance audits
- Serve as a team member of the Grants Committee supporting evaluation of research requests and philanthropic endeavors consistent with Sunshine Act, Anti-kickback statute, Stark Law, and AdvaMed Code
- Review contracts, MSAs, RFPs, and alike for Quality and Regulatory compliance, assure correct representation of the company's Quality/Regulatory activities
- Work with US Division President to support overall business objectives, provide required leadership, and communicate unified executive messaging
- Authority to act on behalf of top management during compliance audits
- Approval of all quality and regulatory policy and related procedures
- Approval of all advertising and promotional materials
- Hiring, training, performance management
Requirements:
- Bachelor's degree required in science, technical, or policy-related field
- Minimum of 10 years quality/regulatory affairs experience required
- Prior management experience required
- Excellent organizational, analytical, and writing skills
Work Environment:
This position requires normal office environment. Requires limited walking, telephone usage, and carrying of files. This position requires heavy use of a computer. Domestic and international travel may be required to support business needs.
Interactions:
Frequent contact with MRSZ Quality Center and Regulatory Affairs departments, must be available for evening conference calls
North America medical device regulatory agencies US FDA and Health Canada and US Customs and Border Protection as needed to support imports handled by the Logistics team
International regulatory agencies as applicable to the company's operations or at the direction of MRSZ
Quality and Regulatory Affairs consultants
