[Hiring] Medical Writer @Pulse Biosciences

Role Description

The Medical Writer develops, writes, and edits high-quality clinical and regulatory documentation required to support the development, registration, and post-market surveillance of medical devices. This role works closely with Clinical Affairs, Regulatory Affairs, R&D, and Quality Engineering to interpret clinical data and ensure compliance with global standards.

To Make an Impact, You Will:

• Audit, edit, and maintain clinical and regulatory documents, including Clinical Evaluation Reports (CERs), Clinical Study Protocols and Reports (CSPs/CSRs), Investigator’s Brochures (IBs), IFUs, Post-Market Clinical Follow-up (PMCF) plans and reports, and risk management documentation.
• Ensure compliance to applicable regulations and guidance (ISO13485, ISO14155, ISO14791, MDR, and EU and FDA guidance documents) and applicable Pulse Biosciences SOPs.
• Collaborate with Clinical, Regulatory, Quality, Biostatistics, and R&D Engineering to ensure aligned messaging and data interpretation.
• Conduct literature reviews and synthesize clinical data from multiple sources.
• Review and edit manuscripts for submission and publication in peer-reviewed journals.
• Translate complex scientific and clinical information into clear, concise, and regulatory-compliance narratives.
• Support document strategy, timelines, and regulatory submissions (e.g., FDA, PMA, CE marking technical documentation).
• Be involved in responses to complex queries such as those issued by notified bodies and stakeholders.
• Maintain document consistency, version control, and audit readiness.
• Contribute to SOP development and process improvements.

Qualifications

• BS in Life Sciences, Medical Technology, Engineering, related scientific field, or relevant experience required.
• 5+ years of medical writing experience in the medical device or pharmaceutical industry or 7+ years general technical writing.
• Writing, editing, and managing clinical and technical documentation utilized in the development of new products and improvement of existing products.
• Experience supporting FDA submissions.
• Excellent writing, editing, and communication skills.
• Strong knowledge of clinical research methodologies and evidence generation for medical devices.
• Strong knowledge of ISO 14155 and EU MDR or FDA regulatory requirements.
• Proficient knowledge and skill in Microsoft Office Suite applications and document management systems.
• Ability to interpret and create complex tabular and graphical clinical data presentations.
• Proficiency in using database tools, such as PubMed, EMBASE, or MEDLINE.
• Excellent scientific writing skills, including an ability to summarize and interpret complicated data effectively, concisely, and persuasively.
• Knowledge of additional languages is an asset.
• Strong attention to detail.
• Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
• Ability to work as a team member, manage multiple projects and deadlines, and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast-growing company.
• Ability to lift 10-15 pounds.

Benefits

• A variety of health insurance plans and supplemental insurance options.
• 401k retirement savings plan.
• Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success.
• Enjoy paid time off, paid holidays, flexible work schedule, and wellness program, including onsite gym and mindfulness classes.
• A commitment to providing a respectful work environment to our diverse workforce.

Company Description

Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients. The Company’s proprietary CellFX® nsPFA™ (nanosecond Pulsed Field Ablation) technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue.

The Company is actively pursuing the development of its CellFX nsPFA technology for use in the surgical treatment of atrial fibrillation and percutaneously in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers.