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Associate Director Regulatory Affairs - Medical Device

Company: Avanos
Location: Alpharetta
Posted on: October 10, 2019

Job Description:

Requisition ID:?1137?Job Title:?Associate Director Regulatory Affairs - Medical Device?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 ground-breaking solutions in everything we do;
  • Making a difference in how we work and collaborate, constantly nurturing our nimble, fast-moving innovation culture;
  • 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 thrives to be independent and different, one that supports and inspires you to excel and to help change what medical devices can deliver, now and tomorrow.??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 www.avanos.com. ?The roleThe Associate Director Regulatory Affairs?provides Leadership and direction in the implementation of regulatory strategies, policies, and procedures that assure domestic and global regulatory compliance. The incumbent will be responsible for the Regulatory Affairs operations of Avanos? Interventional Pain business with global footprints to ensure that business objectives are achieved and comply with applicable regional/country regulations. The incumbent will manage a Regulatory Affairs staff focused on the development and commercialization of new device products and support of current products. Incumbent will act as the Regulatory Representative for the assigned business unit and will represent Avanos in interactions with regulatory agencies, customers and purchasing organizations, outside companies, and relevant professional organizations.?Essential Duties and Responsibilities:
Assure resources are aligned to support the regulatory requirements of Avanos? Interventional Pain business. Coordinate the timing, preparation, and submission of domestic and international regulatory filings. Provide leadership to ensure that Regulatory Affairs attracts, develops and retains the best people and fosters an environment that motivates a diverse team to fully use its capabilities in achieving desired business results. Provide scientific and regulatory consulting services to regions, business units, and new product development teams and liaison with key healthcare and regulatory experts. Serve as consultant and advisor to management and project teams on compliance with applicable regulations. Monitor changes to domestic (federal & state) and international regulations that may impact Avanos businesses and provide oversee strategies to manage required change. Collaborate with Medical Sciences, Clinical Research, Product Safety, Product Development, and Quality Assurance staff to ensure development of safe and efficacious products.?Additional Responsibilities:
Provides Regulatory intelligence and historical RA data to support legal IP and Patent claims in US. Supports global health economics / reimbursement staff by advising on regulatory strategy and filings / licenses world-wide for franchise. Reviews & Approves human clinical medical device trials / studies assuring compliance with applicable regulations. Reports global status of registrations frequently to Franchise Leader and VP level management. Responsible for obtaining / maintaining country specific standards, regulations, and requirements. Develops and maintains technical documentation (MDR) technical file (MDD), STEDs to efficiently provide physical evidence of safety and effectiveness. Assists import / export transportation teams with product Regulatory information and FDA detention or other global customs clearance regulatory documentation Provides expert regulatory advice to GPMS teams world-wide. Actively seeks improvement activities for internal regulatory processes. Produces timely and accurate Regulatory metrics regarding registration status (domestic & International).?Your qualificationsRequired:
Bachelor?s degree and a minimum of eight years or equivalent of relevant regulatory experience in the medical device industry; Knowledge of quality and business processes; Excellent communication skills, both written and verbal; Experience interfacing effectively with domestic and international regulatory agencies.? In-depth knowledge of domestic (FDA) and international regulatory requirements and medical device registrations, design control activities for medical devices, as well as experience with FDA and Notified Body inspections; Analytical, quantitative and problem-solving skills are required; Previous people management experience required; Ability to travel up to 10%, some international.?Preferred:
An advanced degree and/or regulatory affairs certification is beneficial.?? ?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 apply 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.?free onsite gym - onsite cafeteria - 401(k) + 6% match - immediate vesting - benefits on day 1 - uncapped sales commissions - HQ region voted ?best place to live? by USA Today

Keywords: Avanos, Alpharetta , Associate Director Regulatory Affairs - Medical Device, Healthcare , Alpharetta, Georgia

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