Sr. Clinical Scientist.

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.

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 .

The Sr. Clinical Scientist is responsible for creating new and / or updating existing CERs in accordance with directives in the Avanos CER Standard Operating Procedure (SOP).

The Writer may assist to alter the SOP to accommodate policy changes initiated by CER-applicable authorities and / or stakeholders within Avanos.

Additionally, the Writer serves as an effective liaison between the Clinical Evaluation portion of the Avanos’ Global Quality Division and cross-functional teams within Avanos to coordinate CER creation and updates, prepare for audits conducted by Notified Bodies, and address Quality Management issues that include a CER component.

These involve participating in meetings and providing subject matter expertise on clinical evaluation-specific activities in multi-disciplinary teams Post-Market Surveillance (PMS), Research and Development (R&D), Marketing, Quality, Product Supply, and Regulatory teams).

The Writer provides leadership in knowledge of CER-related strategy and documentation including, but not limited to, the European Union Medical Device Regulation (EU MDR) and its associated CER-relevant Medical Device Coordination Group (MDCG) guidance documents, MEDDEV rev 4 (June 2016), and the CER SOP, and may support or participate in the preparation of regulatory submissions as needed.

Job Position Accountabilities / Expectations

Responsible for writing CERs according to the organization’s SOP, the EU MDR and associated CER relevant MDCG guidance documents, and MEDDEV rev 4 (June 2016), as directed by the

senior team member.

Ensure that the CERs are linked to appropriate Quality Systems and Regulatory documents style "color : black">

Risk Management, PMS, etc.) to make certain information is consistent and accessible where needed.

• Assist in the development of schedules to ensure that CER timelines are met.
• Participate in workshops and on initiatives to help define processes globally and keep abreast of CER regulatory requirements and industry trends / practices, ensuring that a proactive ongoing

Review of processes and procedures is in place to maintain a strong regulatory profile, while continually improving process efficiencies.

• Support, and at times, act as a Subject Matter Expert (SME) during audits and inspections pertaining to CER processes and reports.
• Partner with cross-functional business components related to the CER process, such as the Medical Director, PMS, Design Quality Engineers, R&D, and Regulatory Affairs.- Assists with the

maintenance of GCA standard operating procedures.

Key Relationships with the following teams / people

• Regulatory Affairs personnel
• Global Postmarket Surveillance personnel
• R&D personnel
• Notified bodies
• Third party advisors & consultants

Qualifications / Education / Experience / Skills Required

• Bachelors of Science degree in a life science or related field ; or commensurate experience in other fields with 8 years of direct experience as a technical writer in the medical device or related industry
• A minimum of five (5) years of direct technical writing experience in the medical device or related industry
• Prior experience writing, reviewing, and editing clinical evaluation reports
• Basic understanding of biostatistical and clinical research concepts
• Basic knowledge of regulatory requirements and guidances associated with standalone’ regulatory documents (eg, protocols, investigator brochures, and clinical study reports)

Preferred experience for this role :

• Advanced degree in a biologically-related science.
• Experience in the medical device industry and knowledge of CER regulatory requirements, medical / scientific literature-based evidence generation, and CER creation / revision.
• Demonstrated knowledge and experience in quality regulatory compliance, adverse event reporting, medical device risk management processes, and experience with common biostatistical methods.
• Regulatory / Notified Body Audit Experience

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.

free onsite gym benefits on day 1 HQ region voted best place to live’ by USA Today