Director of Regulatory Compliance and QA
2 months ago
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.
-
Director of Regulatory Compliance and QA
2 months ago
Phoenix, United States Growing medical company via The Walstrom Group, Inc. Full timeThe 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...
-
Phoenix, Arizona, United States Growing medical company via The Walstrom Group, Inc. Full timeThe Director of Regulatory Compliance and Quality Assurance plays a pivotal role in collaborating with the executive team, including the President and heads of Regulatory Affairs, to establish and execute a comprehensive global compliance strategy for Regulatory Affairs and Quality Assurance. This position is essential for the development and management of...
-
Phoenix, Arizona, United States Growing medical company via The Walstrom Group, Inc. Full timeThe Director of Regulatory Compliance and Quality Assurance plays a pivotal role in collaborating with executive leadership, including the President and heads of Regulatory Affairs, to shape and execute the global compliance strategy for Regulatory Affairs and Quality Assurance. This position is essential for overseeing the implementation and management of...
-
Phoenix, Arizona, United States Growing medical company via The Walstrom Group, Inc. Full timeThe Director of Regulatory Compliance and Quality Assurance plays a pivotal role in collaborating with the executive team, including the President and the head of Regulatory Affairs, to establish and execute a comprehensive global compliance strategy for Regulatory Affairs and Quality Assurance. This position encompasses the implementation and oversight of...
-
Regulatory Compliance Specialist
1 week ago
Phoenix, Arizona, United States Arizona Official Website of State of Arizona Full timePosition Overview:The Arizona Official Website of State of Arizona is seeking a dedicated professional to join the Division of Public Health Licensing Services as a Regulatory Compliance Specialist. This role involves critical functions related to the evaluation and management of licensing applications for both facilities and individuals, ensuring adherence...
-
Regulatory Compliance Supervisor
1 week ago
Phoenix, Arizona, United States Arizona Official Website of State of Arizona Full timePosition Overview: The role involves overseeing activities within the Division of Public Health Licensing Services, specifically within the Bureau of Special Licensing. This position is responsible for assisting in the issuance of licenses to various licensed facilities and providers, ensuring that all licenses remain current through compliance with...
-
Regulatory Compliance Specialist
5 days ago
Phoenix, Arizona, United States Arizona Official Website of State of Arizona Full timePosition Overview: The role involves engaging in activities related to the Division of Public Health Licensing Services within the Bureau of Long Term Care. Under minimal supervision, the specialist will assess and manage intricate applications for both facility and individual licenses, ensuring adherence to all relevant regulations within designated time...
-
Regulatory Compliance Officer
2 days ago
Phoenix, Arizona, United States Arizona Official Website of State of Arizona Full timeJob Summary:As a Licensing Surveyor Supervisor with the Arizona Department of Health Services, you will play a critical role in ensuring the health and safety of Arizona's citizens by overseeing the licensing and regulation of healthcare facilities and providers. This position requires a strong understanding of federal and state regulations, as well as...
-
Regulatory Compliance Supervisor
1 week ago
Phoenix, Arizona, United States Arizona Official Website of State of Arizona Full timePosition Overview: This role entails overseeing activities within the Division of Public Health Licensing Services, specifically within the Bureau of Special Licensing. The individual will assist in the issuance of licenses to various facilities and providers, ensuring that all licenses remain current through adherence to applicable regulations. Key...
-
Regulatory Compliance Supervisor
5 days ago
Phoenix, Arizona, United States Arizona Official Website of State of Arizona Full timePosition Overview: The role involves overseeing activities within the Division of Public Health Licensing Services, specifically within the Bureau of Special Licensing. This position is responsible for the issuance and maintenance of licenses for various facilities and providers, ensuring adherence to all relevant regulations. Key Responsibilities: ...
-
Regulatory Compliance Specialist
5 days ago
Phoenix, Arizona, United States Arizona Official Website of State of Arizona Full timePosition Overview: The role involves engaging in activities within the Division of Public Health Licensing Services, specifically within the Bureau of Long Term Care. Under minimal supervision, the specialist will evaluate and manage intricate applications for both facility and individual licenses, ensuring adherence to all relevant regulations within...
-
Regulatory Compliance Specialist
1 week ago
Phoenix, Arizona, United States Arizona Official Website of State of Arizona Full timeJob Overview: As a vital member of the Division of Public Health Licensing Services, you will engage in the evaluation and processing of intricate applications for both facility and individual licenses. Your role is essential in ensuring adherence to relevant regulations while operating within established timelines. You will not only issue licenses and...
-
Regulatory Compliance Specialist
1 week ago
Phoenix, Arizona, United States Arizona Official Website of State of Arizona Full timeJob Summary: In this role, you will engage in activities associated with the Division of Public Health Licensing Services, specifically within the Bureau of Long Term Care. Operating under limited supervision, you will review and process intricate applications for both facility and individual licenses, ensuring adherence to all relevant regulations within...
-
Regulatory Compliance Expert
2 days ago
Phoenix, Arizona, United States Katalyst HealthCares & Life Sciences Full timeJob SummaryKatalyst HealthCares & Life Sciences is seeking a highly skilled Quality Engineering Consultant to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the company's medical devices meet all regulatory requirements and quality standards.Key ResponsibilitiesDevelop and Implement Quality Control PlansDesign and...
-
Regulatory Compliance Coordinator
6 days ago
Phoenix, Arizona, United States Arizona Official Website of State of Arizona Full timeJob Overview: The Licensing Operations Specialist plays a crucial role in managing tasks associated with the licensing application processes in the State of Arizona. This position is dedicated to assisting both potential and current clients in navigating the complexities of available licenses and the steps involved in the application process. The...
-
Regulatory Compliance Officer
5 days ago
Phoenix, Arizona, United States Arizona Official Website of State of Arizona Full timePosition Overview: The Contracts Compliance Officer is responsible for delivering proficient and effective support in contract compliance within the Administrative Services Division (ASD). This role ensures adherence to all contractual obligations and maintains up-to-date knowledge of contracts and their requirements, effectively communicating any changes to...
-
QA/QC Inspector Electrical
2 weeks ago
Phoenix, United States World Wide Professional Solutions Full timeWORLD WIDE PROFESSIONAL SOLUTIONS is a project solutions organization committed to implementing lean constructions, collaborative contracting, and execution approaches to enable breakthroughs in performance. WWPS is seeking a QA/QC Inspector for Electrical to join our growing team in Phoenix, Arizona. The successful candidate must be self-motivated,...
-
Regulatory Compliance Specialist
1 week ago
Phoenix, Arizona, United States WillScot Full timeABOUT THE POSITION:The Compliance & Licensing Specialist plays a crucial role in ensuring that WillScot's titles, registrations, and occupational licenses are meticulously maintained and up-to-date, thereby preventing any disruptions to business operations. This position requires regular interaction with regulatory bodies to achieve favorable outcomes,...
-
Regulatory Compliance Specialist
1 week ago
Phoenix, Arizona, United States WillScot Full timeABOUT WILLSCOT:At WillScot, our dedicated team of over 4000 individuals is central to our mission. We prioritize industry-leading compensation and benefits, while fostering professional growth and community engagement.As a premier provider of flexible workspace and portable storage solutions, we cater to a diverse clientele across various sectors from over...
-
Regulatory Compliance Coordinator
5 days ago
Phoenix, Arizona, United States WillScot Full timeABOUT THE POSITION:The Compliance and Licensing Specialist plays a crucial role in ensuring that WillScot's title, registration, and occupational licenses are maintained accurately and consistently. This position is vital to preventing any disruptions in business operations. This role involves regular interaction with regulatory bodies to achieve favorable...