Medical Writer IV — Regulatory Clinical Evaluations

Experis Technology Group; Santa Clara (CA); Sur place; USD 70 000 - 95 000; Plein temps

Résumé du poste

ManpowerGroup’s client, a leader in medical device innovation, seeks a Medical Writer IV to join the Regulatory Clinical Evaluation team in Santa Clara, CA. The role focuses on authoring Clinical Evaluation Plans/Reports and related documents across the product life cycle.

Responsibilities include evaluating clinical evidence from investigations and literature, ensuring quality and regulatory alignment (ISO13485, MDR, EU/FDA guidance), and collaborating with cross-functional partners.

Qualifications

• 6–8 years of medical writing experience in medical devices or pharmaceutical industry.
• Experience with clinical investigations, literature reviews, post-market surveillance, or PMCF writing.
• Strong written and verbal communication skills with cross-functional collaboration.

Responsabilités

• Write and contribute to Clinical Evaluation Plans and Reports (CEP/CER) and related documentation.
• Evaluate and summarize clinical evidence from investigations, literature, PMS, and PMCF.
• Ensure alignment across documents (IFUs, risk files, PMS plans, SSCPs) and regulatory compliance.

Connaissances

Medical writing

Clinical evaluation

Regulatory knowledge

Cross-functional collaboration

Documentation quality

Formation

Bachelor’s Degree in Life Sciences

Outils

Word

Excel

PowerPoint

Outlook

Description du poste

ManpowerGroup’s client, a leader in medical device innovation, seeks a Medical Writer IV to join the Regulatory Clinical Evaluation team in Santa Clara, CA. The role focuses on authoring Clinical Evaluation Plans/Reports and related documents across the product life cycle.

Responsibilities include evaluating clinical evidence from investigations and literature, ensuring quality and regulatory alignment (ISO13485, MDR, EU/FDA guidance), and collaborating with cross-functional partners.