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Associate Director, Quality Assurance and Regulatory Affairs

Job Description

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.