Requisition ID:5969

Job Title:Senior Program Manager, Regulatory Affairs - Labeling

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 AvanosCOVID-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, visitwww.avanos.com.

The Program Manager, Regulatory Affairs, Labeling will have accountability for coordination of labeling creation, revisions, and remediation projects across the organization. The Program Manager will drive project execution in accordance with design & change control requirements and global medical device regulations for medical devices. This role requires frequent interaction and strong collaboration with cross-functional partners for the purpose of coordinating labeling activities and creating efficiencies with intra-project labeling, particularly in the area of remediation. This role has shared responsibility and accountability for ensuring the Quality, global compliance and business process requirements are met across end-to-end labeling activities and that labeling related policies and related objectives are established and are compatible with the strategic direction of the organization. The Program Manager serves as a champion of best practices, compliance, and continuous improvement and participates in/leads business and corporate-wide initiatives. This leadership role is responsible for positive customer experiences as it relates to the global product information, applying specialized knowledge to realize labeling requirements and process strategies across existing and new product development.

Job Position Accountabilities / Expectations

• Ensure labeling (e.g., labels, promotional material, patient and user manuals) promotes safe and effective use of the product and conforms with applicable laws, regulations, standards, and Avanos policies.
• Provide program management across multiple process improvement initiatives/ labeling related workgroups.
• Act as liaison between technical and non-technical departments, facilitating cross-team collaboration and understanding of comprehensive labeling design control requirements.
• Facilitate and coordinate the efforts of team members, cross-functional stakeholders, and labeling related service suppliers to deliver project deliverables per commitments.
• Organize and track projects, proactively manage risks, manage project escalations, prioritize tasks, and meet specific business objectives.
• Support labeling related operational execution - including back up for labeling project tracker, labeling systems implementation, and maintenance activities.
• Provide labeling related performance analytics and metric reporting.
• Drive global labeling related design control strategy - including requirements, verification/ validation, traceability.
• Serve as technical expert in global labeling requirements definition - including global regulatory, technical and standards-based requirements, risk mitigation requirements, and commercial requirements.
• Own, maintain, and update labeling policies, procedures, and work instructions as needed. * Initiate Obsolescence of labeling materials that do not meet requirements.
• Conduct audits of labeling processes and outputs as needed.
• Review and approve labeling related DHF documentation, as needed.
• Bring regulatory compliance questions/issues to the attention of management.

Key Relationships / Customer Expectations

• Excellent verbal & written communication, conflict resolution and negotiation skills as the role will be required to interact with and influence other disciplines involved in labeling development
• Demonstrated successful leadership experience, including in multi-functional teams including Global Sales & Marketing (GSM), Regulatory, Legal, Clinical/Medical Affairs, Quality, Corporate Communications, and other Functional Departments
• Follows logical, structured, and consistent thought processes when planning, speaking, and presenting in meetings
• Ability to organize information into a clear and logical sequence * Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Ability to work independently with minimal direction, including functional representation within teams and committees in order to attain group goals * Considered an expert within the company and may have external presence in area of expertise
• Communicate effectively with all levels of management, business units (Corporate and International), and possesses a high degree of flexibility/selectivity in prioritizing business units and projects to meet established goals
• Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team
• Ability to work as part of and lead multiple teams *
• Excellent project management, strong project leadership skills.
• Have excellent interpersonal skills and be able to work effectively with a variety of personnel from different functional disciplines.
• Develop and execute strategies and plans to meet key operational goals.

Qualifications / Education / Experience / Skills Required

• Minimum of 10 years of experience in the Medical Device Industry or related industry
• Minimum of 5 years regulatory and labeling experience * Advanced knowledge of global labeling regulations, standards, and best practices.
• Advanced experience with regulatory review of labeling * Experience with international regulatory labeling requirements
• Ability to author concise verifiable global labeling requirements
• Ability to distill complex process content, requirements, challenges etc. to brief, concise, and understandable language when communicating across teams
• Manage concurrent projects and priorities, develop project schedules and effectively communicate project status and activities to stakeholders
• Recognize and define big picture and be detailed oriented on project / program / product details - with adaptability to recognize and communicate shifts in strategy, priorities, or implementation needs
• Operate independently and effectively under committed timelines * Knowledge of FDA, MDR, global standards (e.g.,ISO,IEC,AAMI/ANSI), GS1 standards and other global regulatory requirement.
• 10% travel

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, pleaseapply 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.

free onsite gym | benefits on day 1 | HQ region voted 'best place to live' by USA Today