5 Senior Regulatory Technical Writer (Hybrid) Jobs in Alpharetta, GA
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Senior Regulatory Technical Writer (Hybrid)
$67k-83k (estimate)
Full Time | Medical Technology
2 Weeks Ago
Avanos Medical is Hiring a Senior Regulatory Technical Writer (Hybrid) Near Alpharetta, GA
Requisition ID: 5914Job Title: Senior Regulatory Technical Writer (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 .
We are looking for a Senior Technical Writer with substantial experience in the medical device industry to join our team. The successful candidate will produce clear, concise, and accurate medical device labeling including, but not limited to, instructions for use (IFUs), information for patients (IFPs), patient information leaflets (PIL), and product inserts.
You will join our growing team and work closely with cross-functional development teams so that the labeling meets technical specifications and design requirements while ensuring that the end user can read and fully understand the content.
Job Position Accountabilities / Expectations
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 .
We are looking for a Senior Technical Writer with substantial experience in the medical device industry to join our team. The successful candidate will produce clear, concise, and accurate medical device labeling including, but not limited to, instructions for use (IFUs), information for patients (IFPs), patient information leaflets (PIL), and product inserts.
You will join our growing team and work closely with cross-functional development teams so that the labeling meets technical specifications and design requirements while ensuring that the end user can read and fully understand the content.
Job Position Accountabilities / Expectations
- Author medical device labeling with the end user in mind. Use plain language and visual aids as applicable.
- Demonstrate robust critical thinking and effective communication skills, quickly grasping complex technical concepts and making them easy to comprehend in text.
- Achieve a thorough knowledge and understanding of Avanos medical devices during the writing process (e.g., intended use, function, applications, components, risks).
- Attend project meetings as needed and collaborate with cross-functional team members.
- Exhibit a strong knowledge of global regulatory requirements (e.g., FDA, EU MDR, Health Canada) and industry standards (e.g., ISO, IEC), particularly as they apply to labeling.
- Edit and proofread labeling for clarity, grammar, formatting, and adherence to company guidelines, maintaining consistency and branding.
- Update and revise IFUs based on feedback, design change, verification, validation, and changes to regulations and standards.
- Manage and maintain version control of documents.
- Stay current with industry trends, regulations, and guidelines related to medical device documentation.
- Develop optimized IFU templates, procedures, and work instructions, and identify issues associated with design.
- Meet timeline commitments with minimal supervision. Communicate anticipated assignment completion dates.
- Any other duties as assigned by management.
- Build positive internal and external working relationships.
- Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Educate cross-functional colleagues about the significance of regulated labeling and its relation to safety, efficacy, and compliance to gain consensus on labeling requirements.
- Possess a highly motivated, positive, can-do attitude, capable of handling new/unknown requests and challenging situations with ease.
- Bachelor’s degree in a related field or equivalent combination of education and experience.
- 7 years’ in Technical Writing in the Medical Device industry working with external customer-facing materials (patients, clinicians, physicians, HCP, etc)
- Familiarity with InDesign or other desktop publishing software.
- Definitive knowledge of global regulations and industry standards as they relate to labeling requirements and documentation.
- Solid experience working in a medical device quality system.
- 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
$67k-83k (estimate)
POST DATE
06/10/2024
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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