Medical Writer

Pulse Biosciences

About The Position

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.

Requirements

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.
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.

Nice To Haves

Knowledge of additional languages is an asset.

Responsibilities

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.