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Medical Writer

2 hours, 47 minutes ago
United States
Full-time
Senior
Technical Writer
Technical Writing and Documentation
Git
Apply Now
Pulse Biosciences

Pulse Biosciences

Powering the next generation in bioelectric medicine with Nanosecond Pulse Field Ablation technology. Pulse Biosciences pioneers in the research, design and production of our patented Nanosecond Pulsed Field Ablation™ (nsPFA™) technology for use in hig...

Health Care Providers & Services
51-250
Founded 2016
$80M raised
View All Jobs 4

Description

  • Develop, write, and edit clinical and regulatory documents supporting development, registration, and post-market surveillance activities.
  • Audit, maintain, and update documents such as CERs, CSPs/CSRs, IBs, IFUs, PMCF plans and reports, and risk management documentation.
  • Ensure documentation complies with applicable regulations, guidance, and company SOPs, including ISO 13485, ISO 14155, ISO 14791, MDR, and FDA/EU guidance.
  • Collaborate with Clinical Affairs, Regulatory Affairs, Quality, Biostatistics, and R&D Engineering to align messaging and interpret data.
  • Conduct literature reviews and synthesize clinical evidence from multiple sources.
  • Review and edit manuscripts for submission to peer-reviewed journals.
  • Translate complex scientific and clinical information into clear, concise regulatory narratives.
  • Support document strategy, timelines, and regulatory submissions such as FDA PMA and CE marking technical documentation.
  • Respond to complex queries from notified bodies and other stakeholders.
  • Maintain document consistency, version control, audit readiness, and contribute to SOP development and process improvements.

Requirements

  • Bachelor’s degree in Life Sciences, Medical Technology, Engineering, a related scientific field, or relevant experience.
  • 5+ years of medical writing experience in the medical device or pharmaceutical industry, or 7+ years of general technical writing experience.
  • Experience writing, editing, and managing clinical and technical documentation for new product development and product improvement.
  • Experience supporting FDA submissions.
  • Strong knowledge of clinical research methodologies and evidence generation for medical devices.
  • Strong knowledge of ISO 14155 and EU MDR or FDA regulatory requirements.
  • Proficiency with Microsoft Office Suite and document management systems.
  • Ability to interpret and create complex tabular and graphical clinical data presentations.
  • Proficiency using literature databases such as PubMed, EMBASE, or MEDLINE.
  • Excellent writing, editing, communication, and scientific writing skills with strong attention to detail.
  • Ability to work independently with minimal direction, use good judgment, and manage multiple projects and deadlines.
  • Ability to work flexibly in a dynamic, fast-growing environment; additional languages are an asset.
  • Ability to lift 10–15 pounds.

Benefits

  • Variety of health insurance plans and supplemental insurance options.
  • 401(k) retirement savings plan.
  • Stock option awards and Employee Stock Purchase Plan (ESPP).
  • Paid time off and paid holidays.
  • Flexible work schedule.
  • Wellness program, including an onsite gym and mindfulness classes.
  • Learning culture with professional and personal growth opportunities.
  • A respectful, diverse, and inclusive work environment.

Interested in this position?

Apply directly on the company website

Apply Now

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