Medical Affairs Manager - Medical Devices

- Medical subject expert and resource on medical, scientific, technical and therapeutic areas supporting medical sciences' objectives and strategies.

- Contributes medical relevance to risk assessments and quality risk management reviews, analyses and processes such as FMEAs, DFUs, CRBA/CESs, MESL, PIRs, HHAs, Has and CAPAs.

- Conducts exploratory analyses of medical data and data extraction collaborating with Business heads, clinical, global medical safety, quality and product development teams.

- Authors and conducts literature reviews, multilevel in-depth medical analyses, white papers, medical / disease educational materials, summaries for strategy and documentation.

- Medical expert and liaison across all business units and functions including but not limited to clinical, regulatory, quality, research and development, legal, global medical safety and post market surveillance.

- Participates as contributor and reviewer of clinical research protocols and documentation (including but not limited to ICFs, CRFs, safety plans), study reports and statistical analysis plans.

- Serve as a representative to leadership boards and committees as requested. Fully trained as per QA training compliance for representation.