Associate Director, Regulatory Affairs – Remote Position Available In Fulton, Georgia

Job Description:

Requisition ID:

6311

Job Title:

Associate Director, Regulatory Affairs –

Remote Job Country:

United States (US) Here at Avanos Medical, we passionately believe in threethings: Making a difference in our products, services and offers, neverceasing to fight for groundbreaking solutions in everything wedo; Making a difference in how we work and collaborate, constantlynurturing our nimble culture of innovation; Having an impact on the healthcare challenges we all face, andthe lives of people and communities around the world. At Avanos youwill find an environment that strives to be independent anddifferent, one that supports and inspires you to excel and to helpchange what medical devices can deliver, now and in the future. Avanos is a medical device company focused on delivering clinicallysuperior breakthrough solutions that will help patients get back tothe things that matter. We are committed to creating the nextgeneration of innovative healthcare solutions which will addressour most important healthcare needs, such as reducing the use ofopioids while helping patients move from surgery to recovery.

Headquartered in Alpharetta, Georgia, we develop, manufacture andmarket recognized brands in more than 90 countries. Avanos Medicalis traded on the New York Stock Exchange under the ticker symbolAVNS. For more information, visit . Job Summary The Associate Director, Regulatory Affairs, plays a criticalleadership role in ensuring the organization’s medical devicescomply with global regulatory requirements, with a particularemphasis on the European Union Medical Device Regulation (EU

MDR2017/745

). This position is responsible for developing andimplementing regulatory strategies, managing regulatorysubmissions, and ensuring ongoing compliance to support productlifecycle management, market access, and business objectives. TheAssociate Director serves as a key liaison with regulatoryagencies, notified bodies, and cross-functional teams, providingexpertise and strategic guidance to navigate the evolvingregulatory landscape. As the Associate Director, Regulatory Affairs, you will lead thedevelopment and execution of regulatory strategies for thecompany’s medical device portfolio, focusing on MDR compliance forCE marking and post-market surveillance. You will overseeregulatory submissions, technical documentation, and conformityassessment processes, ensuring alignment with regulatoryrequirements and business goals. This role involves collaborationwith cross-functional teams, including Quality, R D, Clinical,and Marketing, to drive timely product approvals and supportregulatory aspects of product development and lifecycle management.

Additionally, you will monitor regulatory changes, provide riskassessments, and implement strategies to maintain compliance andmitigate regulatory risks in global markets. The successfulcandidate will have deep expertise in MDR requirements and a strongability to manage regulatory challenges while fostering a cultureof compliance and continuous improvement. Job Position Accountabilities / Expectations Regulatory Strategy and Compliance Develop and implement comprehensive regulatory strategies tosupport CE marking under the EU Medical Device Regulation (MDR2017/745) for the company’s medical device portfolio. Ensure compliance with global regulatory requirements,including

ISO 13485, FDA 21 CFR

Part 820, and other applicablestandards and regulations. Lead the preparation, submission, and maintenance of regulatorydocumentation, including Technical Documentation and General Safetyand Performance Requirements (GSPR) Support/enable cross functional partners through participationand reviews of strategies associated with risk management, clinicalevaluation, design verification and validation, post-marketactivities, etc. Regulatory Submissions and Approvals Oversee regulatory submissions for CE marking and potentiallyother global markets, ensuring timely approval of new and existingproducts. 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 applicableregulations. Cross-Functional Collaboration Collaborate with R D, Quality Assurance, Clinical Affairs,and Manufacturing teams to provide regulatory input during productdevelopment, design changes, and post-market activities. Support clinical and preclinical activities by ensuringalignment with MDR clinical evidence requirements. Participate in risk management activities, ensuring regulatoryrequirements are incorporated into the product lifecycle.

Post-Market Compliance Support and participate in regulatory audits performed by bothinternal and external authorities Regulatory Intelligence and RiskManagement Monitor, interpret, and communicate regulatory changes, trends,and guidance to ensure the organization remains proactive incompliance. Provide regulatory risk assessments and mitigation strategiesto support business objectives. Implement best practices and continuous improvement initiativesto enhance regulatory processes and systems. Leadership andTraining Lead and mentor the regulatory affairs team, fostering aculture of collaboration, accountability, and excellence as alignedwith the Avanos Values. Provide regulatory training and guidance to internalstakeholders to ensure awareness and understanding of regulatoryrequirements. Continue to increase knowledge in the areas of RegulatoryAffairs, including, but not limited to, MDR 2017/745, ISO 13485,regulatory writing, regulatory strategy, regulatory risk andgoverning guidance and regulations. The Associate Director will act as a key contributor to the globalregulatory function, reporting as a trusted partner to the SeniorDirector of Global Regulatory Affairs. Positions reporting to this job may include: Pr. Regulatory AffairsSpecialist, Sr. Regulatory Affairs Specialist, and RegulatoryAffairs Specialist This position will work closely with the Sr. Director RegulatoryAffairs in EU and team, as well as the

EU AuthorizedRepresentative External Interface:

International Regulatory Bodies (e.g., FDA, Health Canada, NotifiedBody, etc.),

Distributors, and Suppliers, Subject Matter Expertise:

Demonstrate in-depth knowledge of MDR2017/745, including clinical evaluation requirements, PMS, PMCF,risk management, and conformity assessments.

Timely Delivery:

Ensure timely preparation and submission ofregulatory documentation to meet project milestones and businesstimelines.

Effective Communication:

Serve as a key regulatory liaison withinternal and external stakeholders, communicating complexregulatory requirements in a clear and actionable manner.

Problem Solving:

Proactively identify regulatory challenges andprovide strategic solutions to minimize delays or risks tocompliance.

Ethics and Compliance:

Maintain the highest level of integrityand compliance, ensuring that all regulatory activities align withapplicable laws, regulations, and company policies.

Adaptability:

Remain agile in response to the evolvingregulatory landscape, adjusting strategies and processes as neededto maintain compliance and achieve business objectives. Thisposition is a leadership role requiring exceptional regulatoryexpertise, strong cross-functional collaboration, and a proactiveapproach to navigating the complexities of global medical deviceregulations, with a primary emphasis on MDR compliance.

Qualifications and Education:

Bachelor’s degree in a relevant scientific, engineering, ormedical discipline (e.g., Biology, Biomedical Engineering,Regulatory Science). Advanced degree (e.g., Master’s, Ph.D.) in a related field ispreferred. Regulatory Affairs Certification (RAC) or similar professionalcertification is a plus.

Experience:

A minimum of 8 years of experience in regulatory affairs withinthe medical device industry, or 5 years with an advanced degree,and with at least 3-5 years in a leadership or managementrole. Extensive experience with EU MDR 2017/745, including technicaldocumentation, clinical evaluation requirements, conformityassessments, and post-market surveillance processes. Proven track record of successful regulatory submissions andapprovals 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 applicablestandards.

Preferred Qualifications:

Knowledge of additional global regulatory frameworks (e.g.,China NMPA, Japan PMDA, Canada, Australia) is highlydesirable. Experience with digital health technologies, software as amedical device (SaMD), or combination products is a plus. This position requires a high level of regulatory expertise,leadership skills . click apply for full job details