Head of Regulatory – RA/QA/QC (Direct Hire)
Vernon Hills, IL
Job Requisition: 6801
Description for Head of Regulatory – RA/QA/QC:
The Head of Regulatory will oversee a team comprising Regulatory Affairs, Quality Assurance, and Quality Control professionals as well as lead functions such as 510(k), FDA audits, and develop policies and procedures to maintain the quality system for a global medical company.
Responsibilities for Head of Regulatory – RA/QA/QC:
- Establish appropriate organizational structure to ensure compliance with regulatory requirements and that effectively support operational objectives.
- Manage, develop and coach the QA organization which includes: Regulatory Affairs, Quality Control, Complaint Handling and Quality Assurance. Interface and assist Client GmbH with various projects and inspections as necessary.
- Responsible for ISO 13485 compliant quality systems to that ensure maintenance of Certification as critical supplier for company
- Responsible for directly interfacing with external authorities as needed for audits, inspections and other inquiries within the scope of applicable FDA, ISO 13485 and product safety standards.
- Responsible for communicating direction for new FDA regulatory requirements, enforcement actions and other relevant FDA activities that impact the regulatory standing of company products and establishments.
- Responsible for identifying and implementing appropriate training schedules for affected personnel for applicable FDA Quality System Regulations.
- Responsible for ensuring effectiveness of the FDA Quality System Regulations by conducting periodic audits and review of quality data sources and recommending improvements to executive management.
- Establish processes to ensure effective communication to identify product problems and implement appropriate changes as directed.
- Establish processes to support the introduction of new products or changed into the US market in compliance with FDA pre and post market requirements. Interface with US Head of Marketing to establish priorities for product introductions. Interface with Regulatory for pre-market submission strategies and direction; 510(k) or non-notification.
- Establish processes to ensure only cleared products are entered into the company system (SAP) of saleable products for the US market.
- Review product labeling (Instruction Manuals, Catalogs, Advertisements, Electronic media, etc.) to assure compliance to FDA and company policies. Communicate recommendations as needed for direction.
- Ensure Device Master Records are established and maintained for new and on-market products.
Requirements for Head of Regulatory – RA/QA/QC:
- Bachelors Degree in related field.
- Minimum of 5 years of leadership experience in Quality Assurance/Regulatory Affairs within the medical industry
- An expert understanding of the Federal Regulations concerning Medical Devices.
- Excellent communication skills with the ability to represent the company in a professional manner with internal and external contacts.
- Experience with and understanding of cross-cultural differences and the ability to work within this environment. This is crucial for successful employment.
- Familiarity with endoscopic procedures and equipment. This would be most helpful, but is not required.
- Ability to write effective procedures that produces the required level of documentation without overly burdening resources and personnel.
- The ability to make appropriate, risk-based decisions to ensure product and process conformance to applicable requirements that support the operational objectives.
- Adequate organizational skills to manage and coach subordinates to peak performance.
- Familiarity with medical standards such as ISO, ANSI/AAMI and UL.
- The ability to work in a fast-pace environment as well as demonstrated decision-making abilities
- Advanced PC skills in all MS office suite products
- Experience with and understanding of cross-cultural differences and the ability to work within this environment is crucial for successful employment.