Regulatory Affairs Medical Writer

Job Type

Full-time

Description

The position will play a vital role in post-market surveillance activities within our regulatory and clinical affairs team. This position focuses on coordinating and supporting product safety, efficacy, and regulatory compliance as well as supporting the planning, and execution of Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up (PMCF), Clinical Evaluation Plans (CEP), and Periodic Safety Update Reports (PSUR) / Post-market surveillance reports (PMSR). The ideal candidate should possess a strong understanding of regulatory compliance and clinical research methodologies. Effective collaboration with internal teams, and regulatory bodies is crucial to ensure all activities adhere to regulatory requirements, Good Clinical Practice (GCP), and company standards are met

Requirements

Data and Document Management

• Maintain and oversee study documentation, including source documents and study regulatory files.
• Assist in the preparation and submission of clinical study documentation, including Clinical Evaluation Reports (CERs), study protocols, and study reports. Support the preparation of clinical data for regulatory submissions, including FDA submissions and CE mark applications.
• Assist with Post-Market Clinical Follow-up (PMCF) activities to collect data on the long-term safety and effectiveness of medical devices after market release. Support the tracking and reporting of clinical outcomes post-launch.
• Assist in the creation and execution of Clinical Evaluation Plans (CEP) for new and existing medical devices, including designing strategies to collect relevant clinical data and determining appropriate methodologies for product assessment.
• Contribute to the preparation of Periodic Safety Update Reports (PSUR) / Post-market surveillance reports (PMSR), ensuring that all safety and performance data from clinical studies and post-market surveillance are accurately summarized and reported in accordance with regulatory requirements.
  
  

Regulatory and Compliance

• Ensure that all study-related activities comply with federal, state, and local regulations ICH-GCP guidelines, ISO 14155, applicable FDA, ISO 13485, and MDR regulations.
• Assist with the preparation and submission of regulatory documents for post-market surveillance reports.
• Maintain up-to-date knowledge of industry standards and regulatory requirements to ensure adherence to guidelines and internal policies.
  
  

Communication and Reporting

• Prepare study updates and metrics to internal and external stakeholders.
• Understanding of medical terminology, regulatory requirements, and the ability to communicate complex information clearly and concisely.
• Contribute to the preparation of study reports, and regulatory submissions needed.
  
  

Cross-functional Collaboration

• Work closely with internal teams (e.g., Regulatory Affairs, Quality Assurance, Product Development, etc.) and external partners to ensure smooth execution of timely delivery of required reports.
  
  

Qualifications

• Bachelor's degree in life sciences, healthcare, or a related field
• 2-3years of experience in regulatoryclinical affairs, within the medical device, and healthcare industry.
• Knowledge of FDA, EU MDR, ICH-GCP, ISO 14155, IRB, and ISO 13485 regulations.
• Excellent organizational skills with the ability to manage multiple tasks and prioritize effectively.
• Strong written and verbal communication skills, with attention to detail in documentation.
• Ability to work independently and as part of a cross-functional team in a fast-paced environment.
  
  

Preferred Skills

• Experience with medical device writing and clinical trials
• Familiarity with data analysis software and medical terminology