Senior Program Manager, Regulatory Affairs - Labeling (REMOTE).

Avanos; Town of Gates (NY); Remote; USD 90,000 - 150,000; Full time

Job summary

An innovative medical device company is seeking a seasoned professional to lead labeling compliance and project management efforts. This role offers a unique opportunity to impact healthcare solutions and improve patient outcomes. You will be at the forefront of ensuring that products meet regulatory standards while collaborating across teams to drive initiatives that make a difference. With a commitment to excellence and a supportive work culture, this position is ideal for someone passionate about making a meaningful impact in the medical field. Join a company that values innovation and offers a comprehensive benefits package, making your career count.

Benefits

Comprehensive benefits package

401(k) plan with employer match

Onsite gym facilities

Healthcare benefits starting day one

Work/life benefits

Qualifications

• 10+ years in medical device industry with regulatory and labeling experience.
• Advanced knowledge of global labeling regulations and standards.

Responsibilities

• Ensure compliance with labeling regulations and standards.
• Manage multiple projects and facilitate cross-team collaboration.

Skills

Regulatory Compliance

Labeling Standards

Project Management

Communication Skills

Leadership

Analytical Skills

Education

Bachelor's Degree

10+ years in Medical Device Industry

Regulatory and Labeling Experience

Job description

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.

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 to address key healthcare needs, such as reducing opioid use and aiding patient recovery post-surgery. Headquartered in Alpharetta, Georgia, we develop, manufacture, and market recognized brands in over 90 countries. Avanos Medical is traded on the New York Stock Exchange under the ticker symbol AVNS. For more information, visit.

Job Position Accountabilities / Expectations

• Ensure labeling (labels, promotional material, patient and user manuals) promotes safe and effective product use and complies with applicable laws, regulations, standards, and policies.
• Provide program management across multiple process improvement initiatives and labeling-related workgroups.
• Act as liaison between technical and non-technical departments, facilitating cross-team collaboration and understanding of labeling design control requirements.
• Coordinate efforts of team members, stakeholders, and service suppliers to meet project deliverables.
• Organize and track projects, proactively manage risks, escalate issues, prioritize tasks, and meet business objectives.
• Support labeling operational activities, including system implementation and maintenance.
• Provide analytics and metrics reporting related to labeling performance.
• Drive global labeling design control strategies, including requirements, verification, validation, and traceability.
• Serve as a technical expert on global labeling requirements, including regulatory, technical, standards-based, and risk mitigation aspects.
• Maintain and update labeling policies, procedures, and work instructions.
• Manage obsolescence of labeling materials that do not meet standards.
• Conduct audits of labeling processes and outputs as needed.
• Review and approve labeling-related documentation, such as DHF.
• Address regulatory compliance issues with management.

Key Relationships / Customer Expectations

• Excellent communication, conflict resolution, and negotiation skills for interaction across disciplines.
• Proven leadership experience in cross-functional teams, including global sales, marketing, regulatory, legal, clinical, quality, and communications.
• Structured and logical thinking in planning, speaking, and presenting.
• Ability to organize information clearly and logically.
• Capability to meet multiple deadlines with accuracy and efficiency.
• Ability to work independently and represent functions in teams and committees.
• Recognized expertise within the company and possibly externally.
• Effective communication with all management levels and business units, with flexibility in prioritization.
• Deep discipline expertise and broad related knowledge to enhance team efficiency.
• Leadership in managing multiple teams.
• Strong project management and leadership skills.
• Excellent interpersonal skills for effective collaboration.
• Developing and executing operational strategies and plans.

Qualifications / Education / Experience / Skills Required

• Minimum 10 years of experience in the medical device or related industry.
• At least 5 years of regulatory and labeling experience.
• Advanced knowledge of global labeling regulations, standards, and best practices.
• Experience with regulatory review of labeling.
• Familiarity with international regulatory labeling requirements.
• Ability to write clear, verifiable global labeling requirements.
• Skill in simplifying complex process content for communication across teams.
• Experience managing concurrent projects and priorities, with effective stakeholder communication.
• Ability to recognize the big picture while paying attention to details, and adapt to strategic shifts.
• Independent operation under tight timelines.
• Knowledge of FDA, MDR, GS1 standards, and other global regulations.
• Willingness to travel approximately 10% of the time.

Join us at Avanos

Make a difference in our products, solutions, and culture, and positively impact lives worldwide.

Make your career count

We offer a comprehensive benefits package, including competitive salary, healthcare, retirement plans, and work/life benefits. Our 401(k) plan offers a generous employer match with immediate vesting. Enjoy onsite gym facilities, benefits starting day one, and work in a region voted ‘best place to live’ by USA Today.