Director,Regulatory Affairs/Quality Operations Job Mahwah area,New Jersey USA,Quality Assurance

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 Adva Med 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 ISO
13485 regulations
Experience as lead or in‑audit room for FDA, Health Canada and/or ISO
13485 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…


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Director, Regulatory Affairs​/Quality Operations

Director, Regulatory Affairs/Quality Operations