Vyaire Medical REMOTE Clinical Affairs Associate, Clinical Writer in Minneapolis, Minnesota

REMOTE Clinical Affairs Associate, Clinical Writer Help the World Breathe Easier by Collaborating with Innovative Vyaire Employees Around the World As a global leader in respiratory care, we know what we do enables, improves and extends lives. We are an energetic company with a long history of revolutionary products. We devise outstanding solutions that allow patients to lead ordinary lives. We believe the best way to create new 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, establishing last 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://youtu.be/vE6nTH_FElA The Impact You’ll Make in this Role As a(n) Clinical Affairs Associate, Clinical Writer, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

• Assisting in authoring high quality, compliant documentation that conforms to Vyaire processes and procedures along with relevant guidelines and regulations. Documentation includes but is not limited to: Post-market Surveillance (PMS) and Post-market Clinical Follow-up (PMCF) Plans, Summary of Safety and Clinical Performance (SSCP) and PMS/PMCF report documents.
• Assuming primary responsibility for gathering and organizing inputs to support the aforementioned documents. Primary tasks include: performing searches and data extraction on various external databases (MAUDE, DAEN, etc.) and internal databases, organization of data extraction through creation of spreadsheets & tables to support PMS analysis, assist with conducting scientific literature reviews and perform screenings to identify relevant literature to support Clinical Writing.
• Execute general medical writing, editing, and proofreading activities, as needed.
• Ensure inputs are produced in accordance with standard operating procedures, internal and external guidelines (e.g MDD and MDR), and electronic templates.
• Be a key collaborator in project meetings to gather required information for assigned projects and ensure deliverables/inputs to support project documentation are available.
• Collaborating with cross-functional teams and CER writers to gather and organize inputs and ensure continuous improvements to writing processes.
• Support internal and external audits relating to clinical writing documentation.
• Develop a strong working relationship with internal stakeholders to ensure compliance to global regulations and standards for source documents for clinical documentation to support clinical writing activities.
• Performs other duties as required.

Your Skills and Expertise To set you up for success in this role from day one, Vyaire is looking for candidates who have the following required qualifications:

• Associate degree required; bachelor’s degree preferred
• Experience dealing with government regulatory bodies, Proficient Authorities, and Notified Bodies; or respiratory clinical experience

Additional qualifications that could help you succeed even further in this role include:

• Basic understanding of regulations, standards, and guidelines related to medical devices clinical studies, and quality systems, including but not limited to: 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 preferred.
• Strong command of medical and surgical terminology, preferred.
• Strong digital literacy, project management skills, problem solving skills and a high attention to detail.
• Excellent written English skills, able to accurately interpret data and express findings in a clear and concise written manner.
• Attention to detail—style, consistency, grammar, syntax, scientific accuracy.
• Knowledge and experience in internet research.
• Excellent project/time management and organizational skills and ability to work on own initiative.
• Comfortable working in a regulated industry that demands tracking changes to regulatory requirements.
• Optimally collaborate with cross-functional teams, including but not limited to, Quality Assurance, Regulatory Affairs, Engineering, and Design Assurance.

Travel: May include up to [0%][domestic/international] Relocation Assistance: May be authorized Benefit elections are among the most meaningful choices that we make for ourselves and our family. That is why Vyaire offers a comprehensive benefits package that includes various options to meet the diverse needs of our employees. Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status). Atlanta, GA, Chicago, IL, Dallas, TX, Detroit, MI, Houston, TX, Mettawa, IL, Milwaukee, WI, Minneapolis, MN, Nashville, TN Full time 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. To learn about our terms of use, please review Terms & Conditions (http://www.vyaire.com/terms-of-use) . Also, provided here is a link to our Privacy Policy (http://www.vyaire.com/privacy-policy) 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. Apply tot his job Apply To this Job