Standards & Regulations Management Specialist - Remote or Hybrid

Company: Avanos Medical
Location: Alpharetta
Posted on: July 31, 2022

Job Description:

Requisition ID: 4326Job Title: Standards & Regulations Management Specialist - Remote or HybridJob 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 www.avanos.com .The Role As an individual contributor, the function of the Standards & Regulations Management Specialist is to support the Global Quality Department ensuring compliance with standards and the applicable US and international medical device/drug regulations in which the company does business.Job Roles And Responsibilities
  • Owning the Avanos External Requirements process, including Standard Review Board, and responsible to facilitate it for all Avanos business franchises
  • Evaluate the impact of changes to standards and regulations related to country specific requirements for the Avanos global quality system
  • Coordinate with the Quality Planning and Change Control processes to inform new and changing medical device requirements, identify an owner who can conduct gap assessments and define an implementation plan as appropriate, or provide requirement interpretation and implementation plan as required
  • Leads communication and deployment of country regulations and standards with Global Avanos Quality Systems and Regulatory Affairs teams
  • Collaborate across all Avanos business franchises to evaluate the impact of new country regulations and standards for their products/solutions /services
  • Identify any owners of Standard & Regulations gap and impact assessments, monitor progress, and support action items accordingly
  • Support the implementation of any related process changes owned by the global quality system organization
  • Coordinate with the PMO and R&D to ensure resources are allocated for the deployment of the new or revise standards for relevant medical, healthcare and supporting products/solutions/services
  • Collaborate with PMO and R&D to develop an action plan and tracker for new or revised standards for national medical products/solutions/services and design change implementation, manages issues and escalations appropriately
  • Maintain SME positions of influence in standards committees and when appropriate other industry organizations that establish or influence requirements on medical healthcare and supporting products/solutions/services.
  • Coordinate with RA and Quality teams to communicate with our notified body to ensure compliance with international certifications.
  • Support implementation and validation of the Avanos EtQ Reliance electronic system. Required Your Qualifications
    • Years of experience: 5+ years of experience in Regulatory Affairs
    • Education: Bachelor's degree in engineering, or similar
    • Strong broad knowledge of regional and global medical device regulations, requirements
    • Experience in the pharma/medical device industry with experience in regulatory affairs or R&D with direct experience associated with product standards and regulation implementation
    • Knowledge of global/regional regulatory guidelines and standards for medical device industry
    • Working experience in multisite, multi-cultural, multilayer global environment in different time zones
    • Excellent written and verbal communication skills
    • Proven strength in logical, analytical, and writing ability
    • Demonstrated project management skills and attention to detail required.
    • Identifies and resolves problems in a proactive manner. Preferred
      • Certification(s) / License(s): RAC accreditation
      • Preferred experience with a broad spectrum of medical devices across all device classifications
      • Experience as participating member of a standards organization (such as AAMI, ANSI, ISO, etc.) 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 AvanosJoin 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 countOur 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 - uncapped sales commissions - HQ region voted 'best place to live' by USA Today

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