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
Keywords: Avanos Medical, Alpharetta , Standards & Regulations Management Specialist - Remote or Hybrid, Executive , Alpharetta, Georgia
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