Medical Writer

Pulse Biosciences (Nasdaq: PLSE): Join the Future of Bioelectric Medicine 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. Visit pulsebiosciences.com to learn more. Why Join Us? At Pulse Biosciences, we are driven by purpose and innovation. Our Mission: To build a viable Company that designs, produces, and commercializes nano-pulse technology to improve and extend the lives of patients. To solve the needs of patients, physicians, and healthcare providers with high quality and high reliability products and services, developed in accordance with rigorous scientific, engineering, and clinical standards. We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members. Our Culture: A community of creative, forward-thinking individuals tackling challenges with ingenuity and collaboration. Our Commitment: Hiring the best and brightest minds to advance our world-class organization. What You Will Experience: Culture and Purpose - Purposeful and rewarding work collaborating with bright and curious minds brings us together! Innovative Environment - An environment that fosters innovation to take products from concept to human use quickly! Growth Opportunities - Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment! Comprehensive Benefits - A variety of health insurance plans and supplemental insurance options, and 401k retirement savings plan. Ownership and Rewards - Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success. Work-Life Balance - Enjoy paid time off, paid holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes. Diversity & Inclusion - A commitment to providing a respectful work environment to our diverse workforce. 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