Medical Writer

About the Role

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 .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.

To Excel, You Will Bring:

• 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.