Job Description

Medical Writer IV

Duration: 6-12 months from the start date of the worker with possibility to extend contract

Location: St. Paul, MN; Santa Clara, CA; or remote

Onsite or Remote Role-

Schedule: 8 to 5 in respective time zone; if not in PST time zone, occasional meetings after 5 pm might be required.

Top 3 Skills or Any Specific type of Experience you are looking for:

* Experience writing Medical Device MDR compliant CERs, CEPs and SSCPs

*Microsoft Office proficiency

*Vascular or other medical device experience such as Clinical Study

Management

*Education: A bachelor's degree is required along with 6-8 years of

experience.

• Excellent analytical abilities with strong organizational and time management skills

Role Overview:

We are currently seeking a Clinical Evaluation Reporting (CER) / Medical Writer specializing in vascular medical devices. This role is part of the Regulatory Clinical Evaluation team and involves providing both technical and strategic writing support throughout the product development lifecycle.

The primary responsibility is the development of Clinical Evaluation Reports and related documentation for vascular products. The ideal candidate will have experience in clinical study design and management, scientific or medical writing, and/or quality engineering or risk management, along with strong communication skills.

Key Responsibilities:

• Author and contribute to Clinical Evaluation documentation, including Plans/Reports (CER/CEP), PMS and PMCF Plans/Reports, SSCPs, and regulatory responses
• Review, evaluate, and summarize clinical data from sources such as clinical trials, published literature, post-market surveillance, and risk assessments
• Analyze data to support regulatory submissions and product approvals
• Collaborate with internal teams and stakeholders to plan and execute CER-related projects
• Support additional deliverables across clinical, regulatory, quality, and engineering functions as needed
• Work closely with cross-functional teams including Sales & Marketing, R&D, Regulatory Affairs, Clinical Affairs, Quality Engineering, Risk Management, and Medical Affairs
• Maintain in-depth knowledge of assigned products and identify relevant data sources for evaluation
• Review and ensure alignment across documents such as IFUs, patient guides, risk management files, and training materials
• Contribute to responses for regulatory queries and notified body questions
• Prepare documentation for regulatory submissions, risk assessments, and compliance processes
• Ensure high-quality, accurate, and consistent documentation aligned with internal standards and regulatory requirements
• Maintain compliance with applicable regulations and standards such as ISO 13485, ISO 14155, ISO 14971, MEDDEV 2.7.1, MDR, and FDA/EU guidelines

Education and Experience:

Required:

• Bachelor's degree or equivalent practical experience
• 6–8 years of medical writing experience in healthcare/pharmaceutical industries or 8+ years in technical writing
• Experience across medical, pharmaceutical, medical device, or clinical research domains

Preferred:

• Degree in biomedical sciences, medicine, or a related field
• CER writing experience
• Strong communication and interpersonal skills
• Experience working in cross-functional teams
• Strong analytical and multitasking capabilities with effective time management
• Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Outlook

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