Medical Writer

Company Overview:

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion has over 1,400 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, www.artivion.com.

Position Overview:

Responsible for creating, editing, and managing high-quality scientific and regulatory documents that support the development, approval, and lifecycle management of medical devices. This role involves working cross-functionally with internal stakeholders-including Clinical, Regulatory, R&D, and Quality teams-to ensure timely and compliant documentation in line with global regulatory requirements. Manage assigned departmental project tasks/systems in principal areas or responsibilities identified below.

Responsibilities:

• Writing regulatory documents supporting clinical deliverables for product lines.
• Ensure product line compliance with US and International regulations and standards, as applicable to clinical regulatory requirements, including document preparation and submissions.
• Coordinating deliverables for the CER, PMCF, and SSCP process for product lines.
• Collaborate with Clinical, R&D, Quality, Regulatory, Risk Management, Field Assurance, and Marketing.
• Effectively communicate timelines and assist teammates in keeping them.
• Conduct literature reviews and write research summaries related to product lines.
• Prepare product IFUs and assist with labeling and labeling changes (including receipt of applicable translations).
• Collect, query, analyze, distribute and present clinical and pre-clinical data. Develop and maintain any applicable clinical research databases, as necessary.
• Interface with technical representatives, regional managers, and research teams for the purpose of technical training and addressing customer questions/concerns.
• Generate interim and final clinical study reports.
• Communicate with customers and field staff regarding the planning of clinical trials, complaints, problems, and general correspondence.
• Coordinate the execution of peer-reviewed projects (publications, posters, abstracts) and marketing literature.
• Develop clinical protocols and/or investigational plans, informed consent forms, case report forms, handouts, SOPs, analyses, etc. as needed. Prepare status reports, as required.
• Perform literature reviews and reference management using tools such as PubMed and EndNote.
• Other assigned responsibilities (including previously identified tasks being performed at a higher level than one's current title).

Qualifications:

Education:

• Bachelor's degree in life sciences, biomedical engineering, medical writing, or related field (advanced degree preferred: MS, PhD, PharmD, or MD).

Experience:

• 2-5 years of medical writing experience in the medical device, pharmaceutical, or healthcare industry.
• Familiarity with regulatory documentation for medical devices and understanding of applicable regulations (EU MDR, FDA 510(k), etc.).

Skills:

• Excellent written and verbal communication skills.
• Strong attention to detail and organizational skills.
• Ability to interpret complex scientific and clinical data.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) and reference management software.

Preferred Qualifications:

• Experience with Class II or III medical devices.
• Familiarity with document management systems.
• Knowledge of systematic literature review methodology.
• Certification or training in medical writing (e.g., AMWA, EMWA) is a plus.