Requisition ID:5651

Job Title:Associate Director, Regulatory Affairs, On-Market Compliance

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 .

Job Position Purpose and Summary

This RA Associate Director role provides regulatory affairs leadership in the development, registration and life-cycle management of Avanos Medical, Inc. products, with an emphasis on on-market products. This role oversees compliance of on-going activities with applicable regulations and company procedures, develops new procedures and policies as needed, and trains employees as applicable.

Job Position Accountabilities/ Expectations

1. Provide leadership to maintain compliance with domestic and international regulations
2. Provide leadership ensuring that regulatory strategies are developed and implemented in a manner to ensure successful achievement of business objectives working in conjunction with various business units.
3. Ensure that domestic and international regulatory submissions (e.g., 510(k)s, MDRs, Establishment Registrations and Product Listings, CFGs, Technical Files, Design Dossiers, Vigilance Reports, License Applications, MDPRs, etc.) are prepared and submitted accurately, completely and in a timely manner to meet business objectives (e.g., CFR, ISO, MDD, CMDR, etc.).
4. Contribute to and participate in the review of process/product changes, labeling, claims, complaints, etc., to determine the need for any regulatory activities and to ensure compliance to FDA and international requirements.
5. Contribute to and participate in the review of potential quality non-conformance items to determine the regulatory impact and to support continued compliance to FDA and international requirements
6. Support and participate in the follow-up, tracking and assembling of regulatory commitments to regulatory Agencies as required.
7. Provide regulatory support for new/modifications to product design/ project teams.
8. Support and participate in audits performed by internal and external representatives (e.g., FDA, Notified Body, etc.).
9. Lead the implementation of regulatory activities throughout the Avanos - and it's facilities - which includes import-export support.
10. Support the preparation and execution of Field Action activities.
11. Provide leadership to ensure that the organization fosters an environment that motivates a diverse team to fully use its capabilities in achieving desired business results.
12. Embrace the Culture of Accountability and actively demonstrate Avanos behaviors
13. Serve as a regulatory member on product/project teams, and provides business support when needed.
14. Perform other responsibilities, as assigned.
15. Continue to increase education/knowledge in the area of Regulatory Affairs.

Key Relationships/ Customer Expectations

Internal Interface:

• Reports to the Global Sr. Director of Regulatory Affairs, Commercial Regulatory Affairs, for Avanos Medical, Inc
• Partners closely with other Assoc. Regulatory Affairs Directors along with cross-functional Director level leadership.
• Positions reporting to this job may include: Pr. Regulatory Affairs Specialist, Sr. Regulatory Affairs Specialist, and Regulatory Affairs Specialist

External Interface:

Regulatory Bodies (e.g., FDA, Health Canada, Notified Body, etc.), International Distributors, Suppliers and Authorized Representatives

Key Leadership Behaviors

Desired leadership behaviors include:

• Strategic and critical thinking with a visionary mindset
• Personnel engagement and motivation through leadership in action
• Stakeholder engagement through intentional collaboration and communication
• Coaching mindset
• Time management

Active demonstration of Avanos Core Values (i.e., Accountability, Candor, Speed, Global Mindset, Customer-centric, Collaborative)

Qualifications

Required:

• Bachelor's Degree.
• Eight to ten years' experience in Regulatory Affairs.
• Exceptional written and verbal communication skills.
• Team player with excellent organizational skills.
• Detail-focused with ability to multitask effectively and work efficiently within a strict timeline-driven environment.
• Demonstrated success in the preparation and acceptance of both domestic and international medical device submissions for obtaining successful marketing authorizations.
• Effective written and verbal communication skills.
• Strong knowledge of domestic and international medical device laws and regulations.
• Computer Skills, Microsoft windows (Excel, Word, Outlook) and Access.

Preferred:

• FDA QSR, MDD 93/42/EEC, ISO 13485, CMDR. Regulatory Affairs Certification (RAC).

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 .

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