Director Medical Device Safety
hace 5 meses
**Director Medical Device Safety**
**Description Purpose**:
The Director of Medical Device Safety (MDS) leads and develops global Pharmacovigilance (PV) business processes and analyses clinical data sets related to complaint handling, regulatory reporting and clinical development for Bayer medical devices and combination products. The Director of MDS is an expert who provides safety oversight and content contributions to design control, clinical evaluations, vigilance reporting to authorities and post-marketing surveillance for Bayer Pharmaceutical and Consumer Health medical devices and combination products worldwide.
**Scope (global, regional or local)**
The Director of Medical Device Safety will actively manage strategic and, organizational activities required for successful operation of the PMS and Vigilance systems. The incumbent will provide global, regional and local consultation on medical device topics during Health Authority and Notified Body interactions, inspections and audits. as well as to internal and external stakeholders in the course of inspections, contractual agreements, and product quality related topics and task forces.
**Tasks**:
- Generate concepts, define strategies and actively implements medical device PMS and Vigilance standards within the function Pharmacovigilance (PV), Medical Device Safety (PVMDS) and beyond, as a medical device expert serving Bayer Pharmaceuticals and Bayer Consumer Health globally
- Manage and provide content contributions to the medical device vigilance system including reporting to health authorities worldwide, system processing, documentation and training, serious incident electronic reporting, vigilance compliance monitoring for serious incidents and serious public health threats, trending and reporting for non-serious incidents and periodic summary reports
- Manage and contribute to the post-marketing surveillance (PMS) program activities including, PMS system documentation, PMS planning and report management, PMS trending methodologies, analysis and written contributions, management of PMS Trending and Review Board for performance and safety, and device PSUR & Annual Review Board - Provides NPD contributions to design control for medical devices throughout the AS process.
- Interprets global regulations for execution and recommends modification to operational procedures to ensure continued compliance and state of the art industry conformity. - Represents PVMDS during Health Authority inspections and both announced and unannounced Notified Body audits; reviews, responds and implements corrective and preventative actions with respect to medical device vigilance and PMS from audit and inspection findings
- Represent PVMDS organizationally and during governance activities required for successful operation of processes across multiple divisions, functions, sites and diverse cultures globally.
**Labor relations**:
- Person Responsible for Regulatory Compliance (PRRC) Regulatory and Quality and the PRRC Offices across Consumer Health, Pharmaceuticals and Radiology
- Qualified Person for Pharmacovigilance (QPPV) and QPPV Office
- PV leadership team in the course of issue management and project assignments
- Head of Medical Device Safety, Pharmacovigilance
- Head of Product Quality Safety, Pharmacovigilance
- Head of Medical Device and eHelath
- QSC members, Head of Production, Head of PS Compliance, GRA
- Compliance, Legal, Corporate Communication
- QA Heads and delegate QA Gatekeeper of the divisional Product Supply
- Units (Pharma, Consumer Health) and GCPhD, as PV Gatekeeper and PTC / product quality / medical device related work interactions
- Global and local medical experts (TA Heads, GSLs, GMA, Toxicology, Medical Directors, PVCHs)
**Qualifications & Competencies**:
- Master's Degree in Engineering or Life-science Discipline with 6 years of professional medical device industry experience OR Bachelor's Degree in Engineering or Life-science Discipline with 8 years of professional medical device industry experience, and at least 4 years of professional industry experience in quality management systems relating to medical devices and pharmacovigilance.
- Expert knowledge of worldwide medical device legislation and regulations and how to translate this into medical device safety processes, in particular, device vigilance, post market surveillance and design control for medical devices and drug-device combination products
- Deep understanding of product quality specifications, methods of quality control and their interpretation, technical aspects of production and quality assurance and quality control related to medical devices and constituent parts of a combination product
- Extensive experience interacting with, and negotiating with, Health Authorities and Notified bodies worldwide as it relates to medical devices
- Extensive knowledge in Pharmacovigilance, and medical device related regulations and guidelines
- Strong leadership experience, commu
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