Vyaire Medical Clinical Affairs Associate Medical Writer – Clinical Evaluation Report (CER) Writer in Irvine, California
Clinical Affairs Associate Medical Writer – Clinical Evaluation Report (CER) Writer
At Vyaire, we help the world breathe easier. As a global leader in respiratory care, we know what we do enables, improves and extends lives. We are a young company with a long history of revolutionary products. We devise extraordinary solutions that allow patients to lead ordinary lives. We believe the best way to create value for our customers, is to become invaluable. We know a dynamic culture with diversity of thought makes this possible. Our colleagues are people who specialize in exceeding expectations, building lasting relationships and making it a priority to listen. We are dedicated to anticipating what’s next and get it done. We thrive on contributing and making a difference.
To learn more, visit our website: www.vyaire.com
Watch our video: https://www.youtube.com/watch?v=ZDrQoMbMRrI&feature=youtu.be
About this role
Vyaire teams are dedicated to connecting clinicians and patients with the highest quality respiratory healthcare solutions in the market. At Vyaire, you will find a company that puts the customer at the center of all we do. Our culture is one that rewards performance and each interaction we have with a customer furthers our mission to be the global leader in respiratory care.
As a Clinical Affairs, Associate CER writer, you will be responsible for creating Clinical Evaluation documentation including PMS, PMCF, CEP, CER and Literature review matrix. Your documentation will support regulatory submissions to obtain CE mark and maintain CE mark compliant to globally applicable regulations and standards, including MDD/MDR requirements.
Responsible to author high quality, compliant documentation, edit, review, and format documents that conform to Vyaire process and procedure (Clinical Evaluation Reports [CER], Clinical Evaluation Protocols [CEP], Post-market Surveillance [PMS] Plans, Post-market Clinical Follow-up (PMCF) Plans, etc.) and internal document standards, while meeting project timelines.
Assuming primary responsibility for the following tasks: create sorting spreadsheets from raw search data; perform initial screening to identify article type and perform inclusion/exclusion screening; review and summarize relevant medical articles for the State of the Art and Clinical Literature sections of the CER; perform searches on the Maude database for study and/or comparator devices; review raw post-market surveillance data and create tables and/or explanation; prepare literature search protocols and methodologies; and perform additional tasks as required to support Clinical Affairs deliverables.
Attending meetings about document(s) in development and providing document status reports as needed.
Collaborating with other CER writers to ensure continuous improvements to writing processes and for professional training.
Support internal and external audits for CER compliance to MDD/MDR requirements.
Required to attend PMS data review meetings, when applicable, to identify potential safety and/or performance risks or trends requiring consideration into the CER process.
Analyses and evaluates results of literature reviews, product surveys, state-of-the-art determinations, product life-cycle clinical evidence gathering.
Develop a strong working relationship with internal stakeholders to ensure compliance to global regulations and standards for source documents for clinical evaluation are met.
Other duties as required.
Associates and/or Bachelor of Science degree in engineering or a scientific or technical discipline.
A minimum of 2 years of related clinical evaluation writing experience in the medical device, pharmaceutical, and/or medical diagnostics industry.
Basic understanding of regulations, standards, and guidelines related to medical devices clinical studies, and quality systems, including: 21 CFR (e.g., 803,812, 814, 820, and 830); MDD 93/42/EEC; AIMDD 90/385/EEC; MDR 2017/’745; MEDDEV 2.7/1 Rev. 4; ISO 14971; ISO 14155; ISO 13485.
Strong command of medical and surgical terminology
Strong computer skills, project management skills, problem solving skills and a high attention to detail.
Strong communication skills, both written and oral.
Comfortable working in a regulated industry that demands tracking changes to regulatory requirements.
Exceptional organizational skills.
Possess sound judgment and decision-making capabilities in technical, business, and regulatory compliance arenas, with strong expertise of domestic and international regulatory compliance requirements (e.g. FDA QSR and ISO/EN standards)
Proficiency in IT application for centralized database to track and monitor metrics.
Effectively interface with the Quality Assurance, RA, and R&D partners.
Experience dealing with government regulatory bodies, Competent Authorities, and Notified Bodies.
Atlanta, GA, Dallas, TX, Hartford, CT, Indianapolis, IN, Irvine, CA, Madison, WI, Mettawa, IL, Milwaukee, WI, Minneapolis, MN, Philadelphia, PA, Phoenix, AZ
We aspire to a “higher calling” , aligning ourselves with healthcare providers to improve the lives of those who are treated with our devices.
Across the Ventilation, Respiratory Diagnostics and Anesthesia Delivery & Patient Monitoring market segments, we represent the largest pure-play company of our kind, with an ambitious and innovative vision for growth. We hold each other mutually accountable for the quality and reliability of our products and work together toward setting a new market standard in these categories.
We are transforming the future of respiratory care; explore how you can be a part of it.
We are a unified “breathing company”, with a global team that is unrivaled in the respiratory care continuum. Each of our 5,000 people worldwide is critical to achieving our shared purpose of improving the lives of those who are treated with our devices. Our people are empowered to “do the right thing” every day and always put patients first. Our market presence, breadth of product and technical expertise enable us to impact the lives of patients around the world every day.
One of our unique strengths is the diversity of our community. We want to treat each teammate fairly and provide equal employment opportunities regardless of a person’s race, color, religion, gender or gender identity, sexual orientation, age, marital status, national origin, veteran or disability status, or any other characteristic.
One of our unique strengths is the diversity of our community. We want to treat each teammate fairly and provide equal employment opportunities regardless of a person's race, color, religion, gender or gender identity, sexual orientation, age, marital status, national origin, veteran or disability status, or any other characteristic.
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