Join a dynamic regulatory clinical evaluation team supporting the development and life cycle of vascular medical devices. This role is ideal for a detail-oriented medical writer who enjoys turning complex clinical, scientific, and regulatory information into high-quality documentation that supports product submissions and compliance.

Responsibilities

• Develop and refine clinical evaluation deliverables, including Clinical Evaluation Plans, Clinical Evaluation Reports, SSCPs, regulatory responses, and related documentation.
• Review and synthesize evidence from clinical studies, published literature, post-market surveillance, risk documentation, and post-market clinical evaluations.
• Support product applications and submissions by analyzing clinical data and preparing clear, accurate written materials.
• Collaborate with cross-functional partners across regulatory affairs, quality, clinical affairs, engineering, risk management, medical affairs, sales, marketing, and other stakeholder groups.
• Maintain familiarity with assigned products and incorporate relevant information from a wide range of technical and clinical sources.
• Review IFUs, patient materials, training content, risk files, protocols, plans, and reports to help ensure consistency and alignment.
• Contribute to responses to complex questions from external stakeholders and regulatory bodies.
• Ensure documentation quality, accuracy, consistency, and compliance with applicable policies, procedures, regulations, and guidance.

Skills

• Bachelor’s degree or an equivalent combination of education and work experience.
• 6–8 years of medical writing experience in the medical or pharmaceutical industry, or 8+ years of general technical writing experience.
• Experience writing in a medical, pharmaceutical, medical device, clinical research, or related environment.
• Strong written and verbal communication skills with the ability to explain complex information clearly.
• Excellent analytical skills and the ability to manage multiple priorities and deadlines effectively.
• Comfort working in collaborative, cross-functional team settings.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.
• Ability to produce accurate work with strong attention to detail and consistency.

Preferred Skills

• Background in biomedical science, medicine, or another health-related discipline.
• Prior experience creating Clinical Evaluation Reports and related regulatory documents.
• Familiarity with clinical study design, clinical study management, quality engineering, or risk management.
• Experience working with medical device regulatory requirements and guidance, including ISO 13485, ISO 14155, ISO 14791, MEDDEV 2.7.1, MDR, and FDA/EU guidance.
• Ability to support responses to regulatory inquiries and external questions with sound judgment and professionalism.

Horizontal is committed to fostering an inclusive workplace where diversity, equity, and belonging are valued. We welcome candidates with a wide range of backgrounds, experiences, and perspectives, and we encourage everyone to apply if they meet the core requirements of the role.

By applying for this position, you acknowledge and agree that Horizontal Talent may contact you regarding your application using automated technology, including phone calls, SMS/text messages, or email, which may be delivered by our virtual AI recruiter, Alex.

Please apply through this online posting or by visiting our Job Board at www.horizontaltalent.com/job-board. Applications will be accepted for 4 weeks. For those that join the team, we offer competitive compensation and benefits including medical, dental, vision, and retirement. Check out all we have to offer and how you can become part of the Horizontal Talent Team. The pay range for this role is $36 - $70 per hour based on qualifications and experience.