VP, Global Quality & Regulatory Leadership

Job Description Job Description Job Title : Vice President, Quality & Regulatory Affairs Location: Rosemont HQor remote (travel required to site & customers, predominantly California) Employment Type: Full-Time- Hybrid / Exempt About Us: Vantedge Medical is the premier metals-based med-tech solutions partner from concept to full- scale manufacturing. We are at the forefront of precision engineering and innovation, specializing in the development and manufacturing of vital components for medical markets such as Robotic Assisted Surgery, Orthopedics, Surgical Instruments, Dental, and more. Our teams work in unison, collaborating and problem-solving to serve the manufacturing needs of the top Medical Original Equipment Manufacturers (OEMs) around the globe. Making a difference in the lives of patients and their families drives us to go above and beyond every day. With a steadfast commitment to advancing medical technology, we take immense pride in the work we do – and have a lot of fun doing it. About the Role: We are seeking an experienced Vice President of Quality and Regulatory Affairs to lead our quality assurance, quality control, and regulatory compliance functions. This executive role is responsible for ensuring that all medical devices manufactured by our company meet the highest standards of quality and comply with all regulatory requirements in the United States and international markets. The successful candidate will be a strategic thinker with a proven track record in the medical device industry, driving quality improvements, ensuring regulatory compliance, and managing a high-performing team. The Vice President of Global Quality and Regulatory Affairs is responsible for overseeing all facets of the Quality Management System (QMS) and Regulatory Compliance across all Company locations. Theydirectly manage the QA Managers / Directors at our manufacturing locations, providing expert guidance and support and direct involvement in strategic decisions, critical quality events, audits and important customer engagements. This person is responsible for integrating the QMS and Regulatory procedures and policies across all current locations and future acquisitions. Key Responsibilities: Provide leadership and direction for the Quality and Regulatory Affairs departments, ensuring alignment with the company's strategic goals. Develop andmaintain a robust quality management system (QMS) that complies with FDA regulations 21 CRF 820, ISO 13485, ISO 9001, and otherrelevant international standards. Lead interactions with regulatory authorities, including FDA audits, Notified Body inspections, and other regulatory agency interactions. Drive continuous improvement initiatives in quality and regulatory processes to increase efficiency and effectiveness. Ensure that all medical devices are manufactured in compliance with applicable regulations and standards. Collaborate with cross-functional teams to support new product development from a quality and regulatory perspective. Develop and manage department budgets and resources effectively. Lead risk management activities and ensure that risk assessments are conducted according to industry best practices. Stay updated on regulatory changes, interpret them for the company, and implement necessary actions to maintain compliance. Mentor and develop a high-performing quality and regulatory team, fostering a culture of excellence and accountability. Job Requirements / Skills: Bachelor's degree in Engineering, Life Sciences, or related field; Master's degree or advanced certification (e.g., RAC, CQM, CQE) is preferred. Minimum of 10 years of experience in quality and regulatory affairs in the medical device industry, with at least 5 years in a senior leadership role. Extensive knowledge of FDAregulation 21 CFR 820, ISO13485 and ISO 9001 Demonstrated success in leading Quality System audits and managing interactions with regulatory agencies. Strong leadership skills with the ability to inspire and motivate a team. Excellent communication, negotiation, and interpersonal skills. Proven ability to manage multiple projects simultaneously and under tight deadlines. Strategic thinker with strong analytical and problem-solving skills. Up to 50 to 75% travel required. Note: This job description is intended to convey information essential to understanding the scope of the position and is not exhaustive. Duties and responsibilities may evolve over time in accordance with business needs. Benefits: This role will provide a competitive base plusbonus Medical – Dental – Vision – Life Insurance Vacation and Sick Pay 401k Company Description Vantedge Medical is a proven partner to Medical Technology OEMs. For more than 40 years, we have been manufacturing a full suite of expert-level solutions from complex machining and stamping to the manufacturing of complete assemblies for growing markets including Robotic Assisted Surgery (RAS), Orthopedics, Surgical Instruments and Components, Dental implants, and more. Vantedge Medical’s seasoned professionals shorten global supply chains while improving value for our many OEM partners. As a mature Development & Manufacturing Organization, our teams specialize in Electromechanical Assembly, Precision Machining, Sheet Metal Fabrication, and Rapid Prototyping & Engineering Solutions. Our 550,000+ sq. ft. of combined manufacturing space offers a broad spectrum of manufacturing capabilities and flexibility for most levels of mechanical integration. Company Description Vantedge Medical is a proven partner to Medical Technology OEMs. For more than 40 years, we have been manufacturing a full suite of expert-level solutions from complex machining and stamping to the manufacturing of complete assemblies for growing markets including Robotic Assisted Surgery (RAS), Orthopedics, Surgical Instruments and Components, Dental implants, and more. Vantedge Medical’s seasoned professionals shorten global supply chains while improving value for our many OEM partners. As a mature Development & Manufacturing Organization, our teams specialize in Electromechanical Assembly, Precision Machining, Sheet Metal Fabrication, and Rapid Prototyping & Engineering Solutions. Our 550,000+ sq. ft. of combined manufacturing space offers a broad spectrum of manufacturing capabilities and flexibility for most levels of mechanical integration. #J-18808-Ljbffr