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Senior Medical Device Safety Manager

Bayer SAS, Reading

Senior Medical Device Safety Manager

Salary Not Specified

Bayer SAS, Reading

  • Full time
  • Permanent
  • Remote working

Posted 1 day ago, 26 Nov | Get your application in today.

Closing date: Closing date not specified

job Ref: cc2036c4ebc8467e8c7eea0326d7fda2

Full Job Description

  • 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 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 Safety Officer according to §30, 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

    Degree in Engineering or Life-science Discipline with significant medical device industry experience and professional industry 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 life-cycle (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

    At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.

    Be You at Bayer where you have the opportunity to be part of a culture influencing Health for all and Hunger for none.
    • To achieve our vision we see reward for all our employees as incredibly important, so here are some of the benefits you will receive as a Bayer employee. What we offer:
  • Competitive compensation package consisting of an attractive base salary and annual bonus. Individual bonus can also be granted for top performance awards.
  • Mobility Benefit
  • 28 days annual leave plus bank holidays
  • Private Healthcare, generous pension scheme and Life Insurance
  • Wellness programs and support
  • Employee discount scheme
  • State of the art offices
  • International career possibilities
  • Flexible and Hybrid working
  • Help with home office equipment
  • Volunteering days
  • Support for professional growth in a wide range of learning and development opportunities
  • We welcome and embrace diversity providing an inclusive working environment
    • The best possible work-life balance is of great importance to us, which is why we support flexible hybrid working model.

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