Regulatory Specialist, Principal

4 weeks ago

Alpharetta, United States Avanos Medical Full time

Requisition ID:6086

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.

Regulatory Specialist, Principal

This position will develop and implement Regulatory strategies for new product development and significant changes to existing products, to obtain timely regulatory approval globally. This individual will author/approve necessary technical documentation for US, Canada, and EU submissions. This position will be the Regulatory Affairs leader for assigned product line(s).

Essential Duties and Responsibilities:

* Independently prepare global pre-market Regulatory strategies and evaluates significant changes, including timing, costs, and design requirements for registrations worldwide

* Provide regulatory input and technical guidance as a Core Team Member on global regulatory requirements to cross-functional development teams

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

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

* Prepare and submit all aspects of Class II/Class III medical device applications for US FDA, EU MDD/MDR and/or Canada including writing, compilation, submission, interaction with health authority(s), and continuing maintenance.

* Lead discussions with Regulatory bodies including preparation of agendas, slides, and publication of meeting minutes, to support timely approvals or resolution of issues

* Remain current on Regulatory Intelligence in accordance with role and projects, including Global Regulations and Standards * Support regional import/export and quality matters to facilitate clearance of product through transportation and distribution

* Conduct change control impact assessments, inclusive of artwork as well as advertisement and promotional literature to determine compliance with regulations and existing registrations

Qualifications Required:

* Bachelor's degree in a relevant discipline

* Minimum of 7 years of experience in Regulatory Affairs for medical devices

* Prepared and submitted all sections of a US FDA 510k, IDE, or PMA, including writing, compilation, submission, and interaction/negotiation with FDA

* 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

* Demonstrated computer skills, strong written and interpersonal communication skills

* Ability to travel up to 10%

Preferred Requirements:

* Advanced degree in Regulatory Affairs

* RAPS RAC certification

* Experience with FDA and/or international regulatory agency requirements and ISO/IMDRF

* Prepared and submitted all sections of Class II or Class III Health Canada medical device applications

* Prepared and submitted all sections of Class II or Class III medical device applications for EU MDD or MDR

The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.

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

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