Excelsior Executive Search
Director, Regulatory Affairs/Quality Operations
Excelsior Executive Search, Mahwah, New Jersey, us, 07495
Position: Director, Quality Operations/RA
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
#J-18808-Ljbffr
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
#J-18808-Ljbffr