Director, Regulatory Affairs/Quality Operations

Position : Director, Quality Operations / RA

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Job Summary :

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.

Essential Function :

• Establish procedure 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
• Serve as the Management Representative
• Assure that management with executive responsibility understands the quality policy and objectives
• Serve as the US Agent for MRSZ and their subsidiaries
• Implement and execute an internal audit program
• 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 and implement procedures for corrective and preventative action
• 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
• Chair and / or serve global meetings supporting all aspect of US OBL customers
• 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

Decision-Making Authority :

• 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
• Personnel reviews

Position Specifications :

• Knowledge / Educational Requirements
• Bachelor’s degree required in science, technical or policy related field; advanced degree preferred
• Minimum of 10 years quality / regulatory affairs experience required
• Knowledge of FDA, Health Canada and ISO13485 regulations
• Experience as lead or in-audit room for FDA, Health Canada and / or ISO13485 required
• Prior management experience required
• MDSAP
• Skills and Abilities
• Excellent organizational, analytical, and writing skills
• Good interpersonal skills
• Proficient PC skills (word processing, spreadsheets)
• Physical Demands / Work Environment

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.

Positions Supervised : Direct Reports 4 Indirect Reports 8

Regulatory Affairs (2) Regulatory Affairs (4)

Quality Engineering (1) Quality Engineering (4)

Quality Operations (1)

Working Relationships :

• Internal Contacts
• Frequent interaction with all company departments
• Frequent contact with MRSZ Quality Center and Regulatory Affairs departments, must be available for evening conference calls
• MRSZ subsidiaries
• External Contacts
• 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
• Import inspectors / brokers
• Company’s customers
• Quality and Regulatory Affairs consultants

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