Medical Writer

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About the Role:

Medical Writer

Key Responsibilities:

• Write and update CERs, SSCPs, SOAs, and LRRs in compliance with applicable regulatory requirements and guidelines

• Participate in all core steps of systematic literature reviews, including search, screening, data extraction, analysis, and synthesis

• Summarize clinical, non-clinical, and regulatory data to perform risk/benefit analyses on medical devices

• Compare device safety and performance against the state of the art and investigate unexpected outcomes

• Utilize various software systems, including Microsoft Office, EndNote, Distiller, Wrike, and in-house AI tools, to create required documents

• Follow all company procedures, regulatory guidelines, and health, safety, and environmental practices

• Collaborate with cross-functional teams including Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs

• Communicate business-related issues or opportunities to management effectively

Education & Experience Requirements:

• BA, BS, or BSN required; advanced degree preferred

• Minimum of 3 years’ experience in medical writing or related roles

• Experience in the medical device industry and knowledge of CER regulatory requirements, evidence generation, and literature reviews preferred

• Familiarity with clinical research, quality/regulatory compliance, and adverse event reporting is a plus

• Strong oral communication, presentation, project management, and prioritization skills

Additional Qualifications/Desirable:

• Background in life sciences (Dentistry, Optometry, Veterinary Science, etc.) is welcomed

• Experience with CER creation, MEDDEV 2.7.1 rev 4, MDCG/MDR regulations considered a strong advantage

• Proven ability to perform literature searches, summarize clinical conditions, and assess risks and benefits for medical devices

• Experience reviewing supporting device documentation and analyzing device performance data

This is an exciting opportunity for a detail-oriented professional to contribute to regulatory and scientific documentation within the medical device sector while working in a collaborative, cross-functional environment.