To Discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL www.linkedin.com/in/deepak-arya-8a79aa22a/), email your updated resume at Email deepak.arya@collabera.com. Thank you!

Pay Range: $45 to $55 an hour. 

Client Industry: Medical Devices

Locations: Santa Clara, CA; St. Paul, MN; Maple Grove, MN; Plano, TX. 

Duration: 12 Months Contract, with potential extension based on performance and business

Job Summary:

The Medical Writer will develop clinical evaluation and regulatory documentation for vascular medical devices throughout the product lifecycle. The role focuses on evaluating clinical evidence, reviewing scientific literature, and preparing regulatory ready reports and submissions. The successful candidate will collaborate with cross functional teams to support product safety, clinical evaluation, and regulatory compliance. Strong medical writing, analytical skills, and attention to detail are essential.

Key Responsibilities:

• Author Clinical Evaluation Plans, Clinical Evaluation Reports, Summary of Safety and Clinical Performance documents, regulatory responses, and supporting documentation.
• Evaluate and summarize clinical investigation data, scientific literature, post market surveillance findings, and post market clinical follow up evidence.
• Review Instructions for Use, patient guides, risk management files, clinical evaluation protocols, post market surveillance plans, and clinical follow up reports for consistency and accuracy.
• Support regulatory submissions, notified body responses, risk reviews, and regulatory inquiries.
• Collaborate with Regulatory Affairs, Clinical Affairs, Clinical Science, Quality Engineering, Risk Management, Research and Development, and Medical Affairs teams.
• Ensure documentation accuracy, data integrity, and compliance with applicable regulatory standards, guidance, and internal procedures.

Required Qualifications:

• Bachelor’s degree or equivalent combination of education and work experience.
• 6 to 8 years of medical writing experience in the medical or pharmaceutical industry, or 8 or more years of general technical writing experience.
• Experience in medical device, pharmaceutical, clinical research, medical, or scientific writing.
• Strong written and verbal communication, analytical skills, and attention to detail.
• Experience evaluating clinical data, scientific literature, and medical references.
• Proficiency in Word processing, spreadsheets, presentations, and email applications.

Preferred Qualifications:

• Experience authoring Clinical Evaluation Reports and Clinical Evaluation Plans.
• Degree in biomedical sciences, medicine, or a related healthcare discipline.
• Knowledge of ISO 13485, ISO 14155, ISO 14971, MEDDEV 2.7.1, European medical device regulations, and applicable regulatory guidance.
• Experience working with cross functional teams on complex regulatory documentation.

Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long term disability insurance, short term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually AS Applicable)