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.