Director Medical Device Safety

Bayer plc

Später bewerben

We're looking for a candidate to fill this position in an exciting company.

  • 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
  • Serve as the named Deputy Person Responsible for Regulatory Compliance Safety (PRRC-Safety Officer) responsible for ensuring that the obligations referred to in the Medical Device Regulation 2017/745 (MDR) and described in the corresponding Quality System Documents are complied with as it relates to vigilance reporting & post market surveillance, as well as, deputize the named "Sicherheitsbeauftragten" (Safety Officer) according to §30, Medizinproduktegesetz (Medical Device Regulation) for medical devices for which Bayer holds the CE certification, when required
  • 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

  • Master's Degree in Engineering or Life-science Discipline with long-term professional medical device industry experience or Bachelor's Degree in Engineering or Life-science Discipline with eight years of professional medical device industry experience, and at least several years of professional experience in quality management systems relating to medical devices and pharmacovigilance
  • Expert understanding and application of medical device regulations and industry standards globally for design control, device risk management, and post-market surveillance throughout the device lifecycle (e.g. 21 CFR Parts 803, 806, and 820, 822, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and European Union Medical Device Regulation 2017/745;
  • 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, as well as major pharmacopeias (PharmEur., USP), monographs and compendia methods;
  • Strong leadership experience, communication skills as well as ability in networking;
  • Excellent and well-developed analytical thinking combined with high sense of responsibility and accountability;
  • Fluent English; verbally and in writing

Später bewerben

Stellenangebot in: Berlin