Associate Director, Regulatory Affairs - Remote

Requisition ID: 6311 Job Title: Associate Director, Regulatory Affairs - Remote Job Country: United States (US) Here at Avanos Medical, we passionately believe in three things: ? Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do; ? Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation; ? Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world. At Avanos you will find an environment that strives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and in the future. The Avanos COVID-19 Vaccine Policy: This Policy applies to U.S. customer-facing / field-based employees & Avanos leadership: All U.S. customer-facing / field-based employees hires must be fully vaccinated against COVID-19. Proof of being fully vaccinated does not need to be disclosed until a job offer has been made but must be submitted within 48 hours after the acceptance of the job offer. If you have a qualifying medical condition or sincerely held religious belief or practice that precludes you from receiving a COVID-19 vaccine, you may apply for an exemption or deferral after you accept the job offer and before your scheduled start date. The reasonable accommodation provided to the employee, if any, will depend on the employee's job and the applicable facts, but it may include weekly COVID-19 testing and masking requirements. New hires who do not submit, before their scheduled start date, proof of being fully vaccinated or a request for a reasonable accommodation will have their job offer revoked. Avanos is a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter. We are committed to creating the next generation of innovative healthcare solutions which will address our most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Headquartered in Alpharetta, Georgia, we develop, manufacture and market recognized brands in more than 90 countries. Avanos Medical is traded on the New York Stock Exchange under the ticker symbol AVNS. For more information, visit www.avanos.com. Job Summary 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. Job Position Accountabilities / Expectations Regulatory Strategy and Compliance ? Develop and implement comprehensive regulatory strategies to support CE marking under the EU Medical Device Regulation (MDR 2017/745) for the company's medical device portfolio. ? Ensure compliance with global regulatory requirements, including ISO 13485, FDA 21 CFR Part 820, and other applicable standards and regulations. ? Lead the preparation, submission, and maintenance of regulatory documentation, including Technical Documentation and General Safety and Performance Requirements (GSPR) ? Support/enable cross functional partners through participation and reviews of strategies associated with risk management, clinical evaluation, design verification and validation, post-market activities, etc. Regulatory Submissions and Approvals ? Oversee regulatory submissions for CE marking and potentially other global markets, ensuring timely approval of new and existing products. ? Coordinate with Notified Bodies and Competent Authorities, serving as the primary point of contact to address inquiries, audits, and inspections. ? Review and approve regulatory aspects of marketing materials, labeling, and product claims to ensure compliance with applicable regulations. Cross-Functional Collaboration ? Collaborate with R&D, Quality Assurance, Clinical Affairs, and Manufacturing teams to provide regulatory input during product development, design changes, and post-market activities. ? Support clinical and preclinical activities by ensuring alignment with MDR clinical evidence requirements. ? Participate in risk management activities, ensuring regulatory requirements are incorporated into the product lifecycle. Post-Market Compliance ? Support and participate in regulatory audits performed by both internal and external authorities Regulatory Intelligence and Risk Management ? Monitor, interpret, and communicate regulatory changes, trends, and guidance to ensure the organization remains proactive in compliance. ? Provide regulatory risk assessments and mitigation strategies to support business objectives. ? Implement best practices and continuous improvement initiatives to enhance regulatory processes and systems. Leadership and Training ? Lead and mentor the regulatory affairs team, fostering a culture of collaboration, accountability, and excellence as aligned with the Avanos Values. ? Provide regulatory training and guidance to internal stakeholders to ensure awareness and understanding of regulatory requirements. ? Continue to increase knowledge in the areas of Regulatory Affairs, including, but not limited to, MDR 2017/745, ISO 13485, regulatory writing, regulatory strategy, regulatory risk and governing guidance and regulations. 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. Positions reporting to this job may include: Pr. Regulatory Affairs Specialist, Sr. Regulatory Affairs Specialist, and Regulatory Affairs Specialist This position will work closely with the Sr. Director Regulatory Affairs in EU and team, as well as the EU Authorized Representative External Interface: International Regulatory Bodies (e.g., FDA, Health Canada, Notified Body, etc.), Distributors, and Suppliers, ? Subject Matter Expertise: Demonstrate in-depth knowledge of MDR 2017/745, including clinical evaluation requirements, PMS, PMCF, risk management, and conformity assessments. ? Timely Delivery: Ensure timely preparation and submission of regulatory documentation to meet project milestones and business timelines. ? Effective Communication: Serve as a key regulatory liaison with internal and external stakeholders, communicating complex regulatory requirements in a clear and actionable manner. ? Problem Solving: Proactively identify regulatory challenges and provide strategic solutions to minimize delays or risks to compliance. ? Ethics and Compliance: Maintain the highest level of integrity and compliance, ensuring that all regulatory activities align with applicable laws, regulations, and company policies. ? Adaptability: Remain agile in response to the evolving regulatory landscape, adjusting strategies and processes as needed to maintain compliance and achieve business objectives. This position is a leadership role requiring exceptional regulatory expertise, strong cross-functional collaboration, and a proactive approach to navigating the complexities of global medical device regulations, with a primary emphasis on MDR compliance. Qualifications and Education: ? Bachelor's degree in a relevant scientific, engineering, or medical discipline (e.g., Biology, Biomedical Engineering, Regulatory Science). ? 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. Preferred Qualifications: ? Knowledge of additional global regulatory frameworks (e.g., China NMPA, Japan PMDA, Canada, Australia) is highly desirable. ? Experience with digital health technologies, software as a medical device (SaMD), or combination products is a plus. ? This position requires a high level of regulatory expertise, leadership skills, and a collaborative mindset to ensure the organization remains compliant and competitive in the medical device industry. The Associate Director will play a key role in regulatory decision-making and directly support the Senior Director of Global Regulatory Affairs in advancing the company's regulatory and business objectives. Salary Range: The anticipated average base pay range for this position is $128,373 - $214,029 In specific locations, the pay range may vary from the base posted. Avanos Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity or any other characteristic protected by law. If you are a current employee of Avanos, please apply here . Join us at Avanos Join us and you can make a difference in our products, solutions and our culture. Most of all, you can make a difference in the lives, people, and communities around the world. Make your career count Our commitment to improving the health and wellbeing of others begins with our employees - through a comprehensive and competitive range of benefits. We provide more than just a salary - our Total Rewards package encompasses everything you receive as an employee; your pay, health care benefits, retirement plans and work/life benefits. Avanos offers a generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting. Benefits on day 1