8 Regulatory Labeling Specialist (Hybrid) Jobs in Alpharetta, GA
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Regulatory Labeling Specialist (Hybrid)
$72k-94k (estimate)
Full Time | Medical Technology
3 Weeks Ago
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Avanos Medical is Hiring a Regulatory Labeling Specialist (Hybrid) Near Alpharetta, GA
Requisition ID: 5915Job Title: Regulatory Labeling Specialist (Hybrid)Job Country: United States (US)Here at Avanos Medical, we passionately believe in three things:
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 Regulatory Affairs (RA) Specialist will drive and facilitate the global Unique Device Identification (UDI) and labeling requirements. In addition, the staff specialist will collaborate and partner with cross-functional teams and be the primary RA contact for global UDI and labeling including, but not limited to EU/EUDAMED and US FDA/GUDID.
The Individual Will
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 | HQ region voted ‘best place to live’ by USA Today
- 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.
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 Regulatory Affairs (RA) Specialist will drive and facilitate the global Unique Device Identification (UDI) and labeling requirements. In addition, the staff specialist will collaborate and partner with cross-functional teams and be the primary RA contact for global UDI and labeling including, but not limited to EU/EUDAMED and US FDA/GUDID.
The Individual Will
- Serve as the core team member for Avanos regulatory labeling initiatives, including but not limited to NPD (New Product Development), maintenance projects, custom kits, and UDI tasks.
- Produce and maintain medical device labeling, including, but not limited to, package labels, shipping labels, on-device labels, device artwork, and pre-printed packaging artwork.
- Research labeling regulations and prepare labeling specifications for new product development.
- Partner with cross-functional teams to align on required information for regulatory submissions, labeling, and UDI database entries, and provide regulatory input to project teams as required.
- Responsible for completion of Label, Instruction for Use (IFU), and Unquie Device Identification (UDI) Assessments.
- Ensure accuracy and compliance with global labeling and UDI requirements.
- Review product labeling against indicated content to ensure compliance with labeling regulations and requirements (U.S., EU, and Rest of World (ROW) as required), and approve change requests to release labeling documentation for Production/Manufacturing label usage.
- Regulatory Intelligence-Interpret regulations and associated guidance documents to actively monitor and communicate changes related to UDI and labeling.
- Review of labeling content (including IFU and labels) and researching the data for labeling substantiation.
- Any other duties as assigned by management.
- A Bachelor´s degree in a relevant discipline.
- Minimum of 3 years of experience in the medical device labeling and/or Regulatory Affairs.
- Demonstrated computer skills and strong written and verbal communication.
- Broad knowledge and understanding of U.S., EU, OUS, and UDI labeling regulations, as well as overall FDA and MDD/MDR regulations preferred. Ability to stay abreast of medical device regulations.
- Demonstration of strong problem-solving skills. Able to analyze all aspects of a situation, identify potential solutions, and implement the best solution in a timely manner.
- 10% travel
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 | HQ region voted ‘best place to live’ by USA Today
Job Summary
JOB TYPE
Full Time
INDUSTRY
Medical Technology
SALARY
$72k-94k (estimate)
POST DATE
06/07/2024
EXPIRATION DATE
07/05/2024
HEADQUARTERS
HATYAI 203 (CENTRAL 2), SOUTH
SIZE
1,000 - 3,000
FOUNDED
1994
CEO
CHUAH CHIN HUAT
REVENUE
<$5M
INDUSTRY
Medical Technology
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