Job Description
Requisition ID:6310 Job Title:Senior Regulatory Affairs Specialist - Remote 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.
Purpose of the Position:
The Senior Regulatory Affairs Specialist is responsible for ensuring compliance of the organization's medical devices with global regulatory requirements, with a strong focus on the European Union Medical Device Regulation (EU MDR 2017/745). This role includes developing and maintaining regulatory documentation, managing regulatory submissions, and providing strategic guidance to cross-functional teams on regulatory matters. The Senior Regulatory Affairs Specialist will work closely with internal and external stakeholders to facilitate market access, product lifecycle management, and post-market compliance. Position Summary:
In this role, you will serve as a subject matter expert on EU MDR compliance, contributing to the development, submission, and maintenance of technical documentation and ensuring regulatory requirements are met throughout the product lifecycle. You will support regulatory submissions, post-market surveillance activities, and vigilance reporting while collaborating with cross-functional teams such as R&D, Quality Assurance, and Clinical Affairs. Additionally, you will monitor the evolving regulatory landscape, provide input on risk management activities, and support the company's commitment to maintaining the highest standards of regulatory compliance. Accountabilities:
Regulatory Submissions and Documentation
Compliance and Post-Market Activities
Cross-Functional Collaboration
Regulatory Strategy and Guidance
Audits and Inspections
Skills and Competencies:
Regulatory Expertise: In-depth knowledge of MDR requirements, technical documentation, and post-market compliance activities.
Project Management: Strong organizational and time-management skills to manage multiple priorities and deliverables.
Communication: Excellent written and verbal communication skills to convey regulatory requirements clearly to diverse stakeholders.
Problem-Solving: Analytical and critical thinking skills to assess regulatory risks and develop practical solutions.
Collaboration: Ability to work effectively with cross-functional teams and external partners to meet regulatory and business objectives.
Attention to Detail: High level of accuracy and thoroughness in regulatory submissions and documentation.
Adaptability: Ability to navigate complex and evolving regulatory landscapes effectively.
Qualifications and Education:
Bachelor's degree in a scientific, engineering, or medical field (e.g., Biology, Biomedical Engineering, Regulatory Science).
Advanced degree (Master's or Ph.D.) is a plus.
Regulatory Affairs Certification (RAC) or equivalent certification is preferred.
Experience:
Preferred 4 years of experience in regulatory affairs within the medical device industry or 2 years of experience with an advanced degree.
Extensive knowledge of EU MDR 2017/745, including technical documentation, clinical evaluations, post-market surveillance, and risk management requirements.
Proven experience in preparing and managing CE marking submissions and working with Notified Bodies.
Familiarity with global medical device regulations (e.g., FDA, ISO 13485, ISO 14971, MDSAP) is highly desirable.
Experience in post-market regulatory activities, including vigilance reporting and field safety corrective actions.
Preferred Qualifications:
Experience with digital health technologies, software as a medical device (SaMD), or combination products is an advantage.
Familiarity with additional global regulatory frameworks (e.g., China NMPA, Japan PMDA, Canada, Australia) is a plus.
This role offers an opportunity for a regulatory professional to contribute to global compliance initiatives and work on innovative medical device products while supporting the organization's mission to improve patient outcomes and maintain regulatory excellence. Salary Range: The anticipated average base pay range for this position is $86,657- $144,503In specific locations, the pay range may vary from the base posted.
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 #LI-Remote
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Avanos Medical
401(k)
Jan 09, 2025