Job Title: Associate Director, Quality Assurance and Regulatory Affairs
Location: Illinois (Hybrid)
Melio Life Science is partnered with a leading FDA approved medical device company specialising in cardiology.
Overview:
They are seeking an experienced Associate Director of Quality Assurance and Regulatory Affairs to join their team in Illinois on a hybrid basis. The successful candidate will play a pivotal role in leading our quality and regulatory functions, ensuring compliance with FDA regulations, and driving the successful commercialisation of our cardiology devices. The ideal candidate will have a minimum of 8 years' experience in quality management within the medical device industry, with a strong track record of building and leading high-performing teams.
Responsibilities:
· Provide strategic leadership and direction for the Quality Assurance and Regulatory Affairs functions, overseeing the development and implementation of quality systems and regulatory strategies to support business objectives.
· Ensure compliance with FDA regulations, standards, and guidelines applicable to medical devices, including 21 CFR Part 820, ISO 13485, and other relevant requirements.
· Lead the preparation, submission, and maintenance of regulatory filings and applications, including 510(k) premarket notifications, PMA applications, and post-market surveillance activities.
· Collaborate closely with cross-functional teams, including R&D, Manufacturing, Clinical Affairs, and Marketing, to integrate quality and regulatory requirements into product development processes and commercialization strategies.
· Build and manage a high-performing team of quality and regulatory professionals, providing mentorship, guidance, and support to foster a culture of excellence, collaboration, and continuous improvement.
· Develop and implement quality assurance programs, processes, and procedures to ensure the safety, efficacy, and quality of our cardiology devices throughout the product lifecycle.
· Lead internal and external audits and inspections, ensuring timely and effective responses to audit findings and observations, and driving corrective and preventive actions as needed.
· Support international regulatory activities and registrations, including CE Marking and compliance with EU Medical Device Regulation (MDR), leveraging knowledge and experience in global regulatory requirements.
Qualifications:
· Bachelor’s degree in engineering, Life Sciences, or a related field; advanced degree preferred.
· Minimum of 8 years' experience in quality management within the medical device industry, with specific experience in cardiology devices preferred.
· In-depth knowledge of FDA regulations and quality standards applicable to medical devices, including 21 CFR Part 820, ISO 13485, and regulatory requirements for cardiology devices.
· Experience in electrotechnical or related disciplines is highly desirable.
· Proven track record of building and leading high-performing teams, with demonstrated ability to recruit, develop, and motivate talent.
· Strong leadership, communication, and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and influence stakeholders at all levels of the organization.
· Experience with EU MDR compliance and international regulatory submissions is desirable.
· Excellent project management skills, with the ability to prioritize tasks, manage multiple projects simultaneously, and deliver results on schedule and within budget.