Medical Writer

Pulse Biosciences, Inc.

Medical Writer responsible for developing and editing documentation for medical devices at Pulse Biosciences. Collaborating with various teams to ensure compliance and clarity in clinical communication.

Posted 5/12/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

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. Ensures compliance to applicable regulations and guidance’s (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)
Involved in responses to complex queries such as those issued by notified bodies and stakeholder
Maintain document consistency, version control, and audit readiness
Contribute to SOP development and process improvements

Requirements

What you’ll need

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 device
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

Comp & perks

A variety of health insurance plans and supplemental insurance options
401k retirement savings plan
Paid time off
Paid holidays
Flexible work schedule
Wellness program, including onsite gym and mindfulness classes
Stock options awards
Employee Stock Purchase Plan (ESPP) to share in our success

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

medical writingclinical evaluation reportsclinical study protocolsregulatory submissionsclinical research methodologiesevidence generationdocument management systemsdata presentationtechnical documentationISO 14155

Soft Skills

writing skillsediting skillscommunication skillsattention to detailinitiativeteamworkflexibilityproject managementjudgmentconscientiousness