Mid-level industry position
- Medical subject expert and resource on medical, scientific, technical and therapeutic areas supporting medical science's 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.
The Successful Applicant
MBBS is a must.
Experience of working with Medical Devices firms is highly preferred.
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
For those individuals that supervise others, the following statements are applicable:
* Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the company Policy.
Establishes and promotes a work environment that supports the Quality Policy and Quality System