QA/RA Project Manager
DeepHealth
Senior Medical Writer, Clinical Evaluation
Abbott
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $75,300 - $150,700 per year
Job Level
Senior
Tech Stack
Assembly
About the role
- Writes and contributes to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, PMS and PMCF Plans/Reports, SSCPs, Regulatory Responses and other related documentation.
- Evaluates and summarizes clinical evidence including data from sources such as clinical investigations, literature, post-market surveillance, risk, and post market clinical evaluations.
- Analyzes results in preparation for product applications and submissions.
- Collaborates with team members and stakeholders in planning for and supporting CER related projects and processes.
- Supports additional clinical, regulatory, quality and engineering related deliverable as assigned.
- Effectively communicates and collaborates with Sales and Marketing, R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs, Clinical Science, Risk Management and Medical Affairs in completing clinical evaluation project related deliverables.
- Maintains thorough knowledge of assigned products.
- Identifies appropriate sources of relevant data, interprets, evaluates and incorporates information from various sources including literature, clinical data, and medical references.
- Reviews IFUs, patient guides, Risk Management files, Clinical Evaluation Protocols, Clinical Evaluation Reports and Plans (CER/CEP), physician training materials, ensuring alignment of risk information.
- Involved in responses to complex queries such as those issued by notified bodies and stakeholders.
- Authors and contributes to necessary documents for regulatory submissions and communications, risk reviews and other processes such as regulatory inquiries.
- Ensures quality in all deliverables and documentation with attention to detail, consistency and integrity of data.
- Responsible for compliance with applicable corporate and divisional policies and procedures.
- Ensures compliance to applicable regulations and guidance’s (ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, and EU and FDA guidance documents) and applicable Abbott SOPs and DOPs.
Requirements
- Bachelor’s degree in a Science, Medical Technology or equivalent technical degree OR an equivalent combination of education and work experience.
- Minimum 3 years’ relevant experience in a related area such as R&D, Technical Product Development, or Quality in a healthcare industry.
- Must possess comprehensive written and verbal communication, interpersonal, presentation, analytical, project management skills and the ability to prioritize and handle a large volume of projects simultaneously and meet deadlines.
- Writing, editing and managing engineering and technical documentation utilized in the development of new products and improvement of existing products.
- Developing spreadsheets or databases for the capture, assembly, and graphical presentation of metrics.
- Non-product application validation - Process establishment including metrics definition, statistical analysis and analytical techniques.
- Experience in complaint handling, operation or service of diagnostic instrumentation, or medical technology.
- Preferred: Advanced degree in science, biomedical engineering, medicine, nursing or similar health related discipline.
- Preferred: 3+ years of medical writing experience in the medical device or pharmaceutical industry or 7+ years general technical writing; CER writing experience.
- Proficient with Word, Excel, PowerPoint, Outlook, etc.
- Understanding of medical technology
- Experience working in a broader enterprise/cross-division business unit model.
