The Director, of Regulatory Compliance and Quality Assurance is responsible for working with the President, head of Regulatory Affairs, and management peers to define and implement the global RA/QA compliance strategy. Responsibilities include implementing and managing the company’s quality management system to ensure it conforms to our industry's standards and regulatory requirements and working with internal and external constituents to ensure products meet the highest applicable standards and regulatory requirements.
Principal Responsibilities:
Quality Assurance
- Ensure the company’s Quality Management System establishes and maintains sustainable quality assurance processes and compliance with international regulatory requirements and procedures. These requirements include but are not limited to International Standards: ISO 13485, FDA Quality Systems Regulations (QSR, 21 CFR Part 820) and Medical Device Directive (MDD93/42/EEC), CMDCAS Canadian, PMDA, and TGA.
- Responsible for overall planning and management of Quality Assurance (“QA”) systems to ensure continuous design and development, production, and after-market surveillance of safe and reliable products, consistent with established standards and regulatory requirements.
- Implement and maintain an electronic QMS framework for the management of quality system documentation including but not limited to quality system, complaint and CAPA, audit, and training documents.
- Ensure the effectiveness of the Quality System by developing and implementing effective processes and tools to identify, investigate, report, measure, and respond to compliance issues.
- Refine and implement training procedures according to regulatory requirements; develop processes to sustain internal company compliance with ongoing QMS requirements.
- Maintain up-to-date knowledge of applicable Quality System requirements and “best practices.” Advise the management team and RA/QA leadership team on potentially significant changes and risks.
- Maintain positive, proactive relationships with regulatory agencies that will allow the company to maintain substantial compliance with regulation and to have the freedom to operate, globally, in the marketing and distribution of its products and services.
Leadership
- Provide leadership, oversight, and direction. This will include effectively supervising, coaching, and training staff members.
- Create a team environment of open communication by sharing company strategies, priorities, and updates.
- Provide departmental leadership in the implementation of Lean processes and improvements.
- Integrate the needs of the quality function with the needs of the leadership teams and across the company.
- Interface with customers regarding quality and regulatory issues and business development opportunities.
Knowledge, Skills, and Abilities:
- BS degree and in a technology/science-related discipline preferred.
- 8+ years of Regulatory/QA experience, preferably in the medical device industry or other FDA-regulated environment. Experience submitting medical device license applications for US, Europe, and Canada is preferred.
- 5 years of experience establishing, implementing, and maintaining quality systems that meet the requirements of CMDR/ISO 13485, FDA/QSR, and MDR.
- Experience working in a lean manufacturing environment.
- Demonstrated leadership, technical aptitude, and problem-solving skills.
- Proven experience working directly with domestic and foreign regulatory authorities.
- Knowledge of QSR, ISO, CE, and QA principles.
- Experience managing regulatory processes in Japan, China, India, and the Middle East is a plus.
- Proven expertise in navigating through FDA requirements.
- Excellent communication skills, including verbal and written.
- Ability to handle ambiguity and changing priorities and to propose solutions for resolution.
