Medical Writer (Medtech)

TL;DR

Medical Writer (Medtech): Generating and developing documents for clinical evaluations and investigations with an accent on CER, PMCF, and EU MDR compliance. Focus on performing systematic literature reviews and drafting high-quality, submission-ready clinical study documentation.

Location: Must be based in the US (hybrid or fully remote), preferably in the EST zone

Salary: $105,000–$115,000 base

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows in intensive care and cardiovascular procedures.

What you will do

• Lead the development of Clinical Evaluation Reports (CER) and documentation in alignment with EU MDR and MEDDEV 2.7/1 Revision 4.
• Contribute to Post-Market Clinical Follow-up (PMCF) through literature review and clinical data analysis.
• Perform comprehensive systematic literature reviews using PubMed, Embase, and other search engines.
• Draft and edit clinical study documentation, including investigational plans, protocols, and Investigator’s Brochures.
• Develop manuscripts for peer-reviewed medical journals and abstracts for medical congresses.
• Optimize Clinical Affairs SOPs and serve as a subject matter expert on clinical aspects of technical documentation.

Requirements

• Bachelor's degree in a relevant scientific discipline.
• Minimum of 3 years of medical writing experience.
• Must be based in the US.
• Strong working knowledge of EU MDR, MEDDEV guidance, ISO 14155, and ICH guidance.
• Proficiency in PubMed, Embase, and literature search engines.
• Excellent project management and oral/written communication skills.

Nice to have

• Direct experience with clinical evaluations within the Medical Device industry.
• Medical writing certification.
• Experience with DistillerSR, EndNote, or other literature review tools.

Culture & Benefits

• Health, Dental, and Vision insurance benefits.
• 401k plan with company match.
• Paid Time Off and Parental/Caregiver Leave.
• Wellness initiatives and Health Assistance Resources.
• Tuition Reimbursement and Life Insurance.