Clinical Evaluation Medical Writer

Overview

• Contribute to clinical evaluation and regulatory compliance in the medical device industry.
• Author reports and plans adhering to European Union Medical Device Regulation (EU MDR).
• Perform systematic literature searches and critical appraisals for clinical data synthesis.
• Collaborate with stakeholders to ensure timely deliverables and project milestones.
• Utilize advanced Microsoft Word for document control and structured formatting.
• Work on-site or remotely based on experience and profile suitability.
• Engage in post-market surveillance and periodic safety update reporting.
• Support audit and submission queries with comprehensive responses.

Key Responsibilities & Duties

• Author and maintain clinical evaluation reports and post-market surveillance documentation.
• Conduct comprehensive literature searches and critically evaluate clinical evidence.
• Develop state-of-the-art product family documentation for regulatory purposes.
• Coordinate with stakeholders to manage project timelines and deliverables.
• Ensure compliance with EU MDR and other regulatory guidelines.
• Maintain databases of peer-reviewed literature and clinical data.
• Provide guidance to entry-level professionals and support cross-functional assignments.
• Communicate effectively with internal teams to share information and support decision-making.

Job Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Medicine, Biomedical Engineering, or Public Health.
• Minimum 2 years of experience in clinical evaluation or post-market surveillance.
• Proficiency in Microsoft Office, particularly advanced MS Word functionalities.
• Strong expertise in PSUR and PMCF writing under EU MDR compliance.
• Solid project management skills for timeline and stakeholder coordination.
• Ability to critically appraise and synthesize clinical evidence.
• Knowledge of regulatory guidelines for clinical evaluation requirements.
• Flexibility to work on-site or remotely based on profile suitability.