Director Regulatory Affairs and Quality Assurance

Director, Regulatory Affairs and Quality Assurance
Irvine, CA (1x onsite/week)

POSITION PURPOSE:
The Director of Quality Assurance and Regulatory Affairs is responsible for working with all levels of employees within the organization in providing strategies that include the development and continuous improvement of a sustainable and compliant Quality System; U.S. and International regulatory product submissions; support of clinical studies to meet regulatory and marketing requirements; and involvement with corporate business strategy development.

ESSENTIAL FUNCTIONS

• Manage the hiring and training of RA and QA staff.
• Position will oversee and manage multidisciplinary company functions and is an authorized representative for the Regulatory and Quality departments and is authorized to sign and approve quality system documents requiring regulatory approval.
• Provide strategic and tactical RA and QA initiatives to support the business objectives and patient quality focus.
• Assists CEO in short/long-term project planning.
• Participate in pre-clinical study planning. Provide guidance for GLP pre-clinical studies towards submission goals.
• Work with R&D to determine clinical feasibility of new products and all required documentation related to developing and implementing new products
• Conduct critical assessments via internal audits of ALL processes and equipment to identify areas of improvement
• Conduct Management Reviews as scheduled, be responsible for evaluation and dissemination of company quality standards, initiatives, guidelines.
• Maintain Quality Assurance programs, policies, processes, and procedures to ensure that performance and quality of products conform to established standards
• Establish and maintain US and International product and manufacturing certifications
• Establish and maintain training curricula required for employees to ensure compliance with regulations, standards, HIPAA and EHS.
• Interact with the FDA and other governmental agencies on a global basis regarding regulatory and compliance issues.
• Review sales and marketing materials for conformance to regulatory requirements.
• Participate in the Company's strategic development & implementation of Quality Systems.
• Make decisions to release or hold commercially approved products based upon conformance to requirements.
• Assure compliance to worldwide regulatory requirements based upon Quality Program assessments.
• Initiate and ensure quality complaints are fully investigated, documented, and reported in compliance with SOP's
• Establish and manage compliant Validation and SDLC (Software Development Life Cycle) Programs

EDUCATION/EXPERIENCE REQUIREMENTS

• Minimum of 10 years' experience in management of regulatory and quality for medical devices (Class I/II/III). In depth knowledge of FDA and ISO regulations.
• A minimum of a bachelor's degree in science, engineering, biology related field.
• Demonstrated success in development of clinical and regulatory strategies, through all phases of deployment such as protocol development, site selection, and trial execution.
• Successful management of major U.S., multi-center, prospective pivotal clinical trials. Proven leadership in compliance with respect to FDA regulations and guidelines related to clinical strategy, GLPs, SOPs, submissions, product launch, labeling, advertising and promotion, and medical device reporting.
• Demonstrated success in building and managing RA and QA departments.
• Ability to function in a small company, "hands-on" environment.
• Advanced knowledge of regulatory requirements for PMAs, Annual Reports and promotional materials.
• Self-starter. Ability to operate in a small company dynamic environment.
• Ability to drive meetings with various stakeholders:
  • Senior management
  • Food & Drug Administration (FDA) and regulatory bodies
  • Investors
  • Expert advisors
• Excellent attention to detail.
• Passion, energy, personal drive and motivation.