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

Avanos; Georgia; Remote; USD 90,000 - 120,000; Full time

Job summary

A leading medical device company is seeking an experienced Labeling Regulatory Manager to oversee the labeling process and ensure compliance. You will act as a key liaison between technical departments, manage multiple projects, and drive the global labeling strategy. Qualified candidates should have over 10 years in the medical device industry, strong communication skills, and an advanced understanding of labeling regulations. This position is based in Alpharetta, Georgia and offers a competitive salary with excellent benefits.

Benefits

Generous 401(k) employer match

Free onsite gym

Benefits on day 1

Qualifications

• Minimum of 10 years of experience in the Medical Device Industry.
• Minimum of 5 years regulatory and labeling experience.
• Advanced knowledge of global labeling regulations.

Responsibilities

• Ensure labeling promotes safe and effective product use.
• Act as liaison between technical and non-technical departments.
• Drive global labeling design control strategy.

Skills

Excellent verbal & written communication

Project management

Strong leadership skills

Education

10+ years in Medical Device Industry

Bachelor's degree in a relevant field

Tools

Regulatory compliance tools

Project management software

Job description

Overview

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.

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.

Job Position Accountabilities / Expectations

• Ensure labeling 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 GS1 standards and other global regulatory requirement.
• 10% travel

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