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Regulatory Specialist, Principal

3 months ago

San Diego, United States Avanos Medical Full time

Requisition ID:6013

Job Title:Regulatory Specialist, Principal

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 www.avanos.com.

Job Position Purpose / Summary

With minimal oversight, this position will lead on-market product sustaining and compliance regulatory activities as part of a global team to develop and implement strategies that will ensure timely introduction of substantial changes to market in a fast-paced environment. You will author complete and scientifically sound regulatory submissions and lead interactions with US FDA, EU Notified Body and country regulatory contacts to ensure timely approvals.

Job Position Accountabilities / Expectations

  • Author and submit all aspects of Class II/Class III medical device applications for US FDA, EU MDR and/or Canada including writing, compiling, and submitting as well as maintaining existing EU MDD Technical Files.

  • Assess the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations.

  • Provide leadership, oversight, and accountability in the development and implementation of broad-scale compliance initiatives.

  • Provide expertise and guidance for applicable new or revised global regulatory requirements and standards relevant to Avanos products and Quality Management System (QMS).

  • Independently prepare detailed impact assessments and action plans of new or revised regulations and applicable standards (gap analysis).

  • Demonstrate appropriate risk-based decision-making, and prioritize key activities to maintain product conformity.

  • Support internal and external audits as Subject-Matter-Expert for sustaining state-of-the-art conformity during the product lifecycle and QMS.

  • Provide regulatory input and technical guidance to cross-functional teams

  • Partner with global regulatory affiliates and leverage product expertise to provide submission documentation for expedited international market access and sustaining support.

  • Collaborate with other departments to ensure CAPAs are addressing root cause.

  • Remain current on Regulatory Intelligence in accordance with role and projects, including Global Regulations and Standards.

  • Share knowledge and collaborate on a wide range of competing business priorities and tailor risk-based compliance solutions accordingly.

  • Develop and deliver training programs to educate internal teams on product compliance obligations and best practices. Network with external stakeholders, such as regulatory authorities, industry associations, and certification bodies to stay informed on regulatory changes.

  • Support regional import/export and quality matters to facilitate clearance of product through transportation and distribution.

Required Qualifications:

  • Bachelors degree required or 7+ years of Regulatory experience in the medical device industry

  • Experience with EU MDR, FDA and/or international regulatory agency requirements as well as ISO/IMDRF

  • Excellent written and verbal communication skills; Must be able to write clear, understandable technical documents, i.e. regulatory documentation and scientific presentations

  • Led negotiations/discussions with FDA, Health Canada, and/or Notified Bodies related to pre-market submissions and/or resolution of post-market concerns or follow-up for medical devices

  • Led the development and implementation of global Regulatory strategy for new products or significant changes to existing products

  • Experience performing review of Advertisement and Promotional materials

  • Led or participated in performing CAPA root cause investigations, product non-conformances, recalls, etc.

  • Demonstrated computer skills, strong written and interpersonal communication skills * Ability to travel up to 20%

Preferred Qualifications:

  • Experience in FDA pre-sub, 510(k), PMA and/or Technical File/Design Dossier *

  • Good understanding of product development process and design control through knowledge of US FDA and international medical device regulations

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.

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.

benefits on day 1