Associate Director, Regulatory Affairs - Remote
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US
Company:
Avanos Medical is a medical device company focused on delivering clinically superior breakthrough solutions to improve patient outcomes globally.
Summary:
The Associate Director, Regulatory Affairs will lead regulatory strategies to ensure compliance with global regulations for medical devices. Candidates should have extensive experience in regulatory affairs, particularly with EU MDR, and at least 8 years in the medical device industry.
Requirements:
Credentials: Bachelor’s degree in a relevant scientific, engineering, or medical discipline, Advanced degree (e.g., Master’s, Ph.D.) in a related field is preferred, Regulatory Affairs Certification (RAC) or similar professional certification is a plus.
Experience: A minimum of 8 years of experience in regulatory affairs within the medical device industry, or 5 years with an advanced degree, and with at least 3-5 years in a leadership or management role., Extensive experience with EU MDR 2017/745, including technical documentation, clinical evaluation requirements, conformity assessments, and post-market surveillance processes., Proven track record of successful regulatory submissions and approvals for CE marking and other global markets., Experience working with Notified Bodies, Competent Authorities, and regulatory agencies., Familiarity with global medical device regulations, including FDA 21 CFR Part 820, MDSAP, ISO 13485, and other applicable standards.
Job Description:
The Associate Director, Regulatory Affairs, plays a critical leadership role in ensuring the organization’s medical devices comply with global regulatory requirements, with a particular emphasis on the European Union Medical Device Regulation (EU MDR 2017/745). This position is responsible for developing and implementing regulatory strategies, managing regulatory submissions, and ensuring ongoing compliance to support product lifecycle management, market access, and business objectives. The Associate Director serves as a key liaison with regulatory agencies, notified bodies, and cross-functional teams, providing expertise and strategic guidance to navigate the evolving regulatory landscape.
As the Associate Director, Regulatory Affairs, you will lead the development and execution of regulatory strategies for the company’s medical device portfolio, focusing on MDR compliance for CE marking and post-market surveillance. You will oversee regulatory submissions, technical documentation, and conformity assessment processes, ensuring alignment with regulatory requirements and business goals. This role involves collaboration with cross-functional teams, including Quality, R&D, Clinical, and Marketing, to drive timely product approvals and support regulatory aspects of product development and lifecycle management. Additionally, you will monitor regulatory changes, provide risk assessments, and implement strategies to maintain compliance and mitigate regulatory risks in global markets. The successful candidate will have deep expertise in MDR requirements and a strong ability to manage regulatory challenges while fostering a culture of compliance and continuous improvement.
The Associate Director will act as a key contributor to the global regulatory function, reporting as a trusted partner to the Senior Director of Global Regulatory Affairs.
