Technical Writer - PSUR Consultant

Job Title: Technical Writer – PSUR Consultant Key Responsibilities: Prepare, update, and maintain PSURs to ensure compliance with EU MDR 2017/745, FDA, and other international regulatory standards. Collect and analyze safety and post-market surveillance data from internal and external sources. Collaborate with cross-functional teams including Regulatory Affairs, Quality Assurance, Clinical, and Risk Management to ensure accurate and timely reporting. Conduct literature reviews and integrate findings into PSURs. Ensure all PSURs are written clearly, concisely, and scientifically, aligning with regulatory requirements. Maintain version control, document management, and audit readiness of PSURs. Assist in writing and editing risk management reports, clinical evaluation reports (CERs), and other regulatory submissions as needed. Stay up to date with evolving regulations, guidance documents, and best practices related to post-market surveillance and regulatory reporting. Qualifications & Skills: Bachelor’s or Master’s degree in a scientific, technical, or medical field (e.g., Life Sciences, Biomedical Engineering, Regulatory Affairs). 2+ years of experience in technical writing, regulatory writing, or post-market surveillance in the medical device or pharmaceutical industry. Strong understanding of EU MDR (Article 86), ISO 13485, ISO 14971, FDA regulations, and other relevant global requirements. Experience in analyzing safety data, clinical literature, and regulatory reports. Proficiency in Microsoft Office Suite, document management systems (DMS), and regulatory submission tools. Excellent written and verbal communication skills, with the ability to translate complex data into clear, structured reports. Strong project management skills with the ability to manage multiple deadlines in a fast-paced environment. Experience working with cross-functional teams and regulatory bodies is a plus.