Device Vigilance Leader
Location:
Hanover , New Jersey
Posted:
October 16, 2017
Reference:
1479808487
Your tasks and responsibilities
The primary responsibilities of this role, Device Vigilance Leader are to:

  • Generate concepts and actively implement medical device standards in accordance with corporate policy and applicable global regulations for complaint handling, global reporting, and trending based on analysis of clinical data sets;
  • Lead trend evaluation and analysis of safety event data sets associated with the device user interface across Consumer Health and Pharmaceutical product portfolios;
  • Act as Deputy of the Head of Device Safety Management in product quality issue management and Pharmacovigilance (PV) representative in the Product Quality and Safety Committee (PQSC) for medical device topics;
  • Be responsible for PV input into user requirements, design validation, device risk assessment and Post-Market Surveillance of medical devices;
  • Submit periodic reports to leadership on key clinical safety metrics associated with the user interface and emerging product issues and present data at management review meetings;
  • Act as a Pharmacovigilance representative on global Device Development Teams (DDTs) for medical devices across Consumer Health and Pharmaceutical product portfolios;
  • Evaluate clinical study protocols to ensure fulfilment of medical device requirements and implement new concepts for conforming with regulations when identified;
  • Act as a Pharmacovigilance representative and be responsible for Post-Market Surveillance activities and contributions related to safety events associated with the device user interface across Consumer Health and Pharmaceutical product portfolios;
  • Represent PV Device Safety Management as a subject matter expert and present processes during internal and external audits (including Notified Body Audits) and National Competent Authorities inspections;
  • Interpret global regulations for execution and recommend modification to operational procedures to ensure continued compliance and state of the art industry conformity;
  • Actively drive continuous improvement of medical device related processes including active, solution based, collaboration with respective internal and external partners;
  • Provide experienced based training to internal and external personnel to ensure compliance with regulations and conformity with requirements for best-in-class medical devices standards;
  • Work within Bayer medical device network to establish key partners and ensure global awareness and adherence to medical device policy and procedures.


Who you are
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:

Required Qualifications:

  • Master's Degree in Engineering or Life-science discipline with six (6) years of professional medical device industry experience in a Research & Development (R&D) position OR Bachelor's Degree in Engineering or Life-science discipline with eight (8) years of professional medical device industry experience in a R&D position;
  • 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, ISO13485, ISO14971;
  • European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and working understanding of Medical Device Regulations and industry of implementation);
  • Industry experience and clinical understanding of human factors related to the device user interface and familiarity with complaint track and trend concepts with ability to diagnose safety risks related to medical devices;
  • Good scientific application of statistical methods used for evaluating complaint trends and establishing thresholds for routine trend reviews related to human factor, malfunction, and other issues associated with the user interface and user safety;
  • Excellent analytical skills, data collection, management and reporting skills;
  • Demonstrated ability working with technical type issue management, as well as an understanding of design and functionality of medical devices;
  • Well experienced and able to develop and administer management information systems for complaints trending and deficiency identification and correction;
  • Experience applying engineering concepts such as design of experiments, risk management, validation, methodical problem solving, and statistical analysis to drive continuous improvement activities/ process development for medical device safety;
  • Experience and knowledge of device design & development through to post marketing (device life-cycle);
  • Experience in project management with demonstrated success in effectively managing teams, executing on projects, and communicating expectations;
  • Proven oral and written communication skills;
  • Proven analytical and critical thinking skills;
  • Excellent knowledge of patient safety, quality, clinical research, strategic planning, health biostatistics or epidemiology;
  • Excellent presentation and writing skills (summary reports, evaluations, authority presentations, etc.);
  • Strong "influence management" skill set demonstrated in both the healthcare delivery and corporate environments;
  • Strong leadership skills and ability to work collaboratively within a diverse, global, matrixed organization;
  • Excellent communications skills in English (written and spoken);
  • Self-starter with proven ability to successfully work with minimal supervision;
  • Strong sense of responsibility, balanced decision making, and high ethical standards, confidentiality and discretion keeping;
  • Excellent written and verbal communication skills with the ability to collaborate and build networks;
  • Experience in multidisciplinary teams as well as in the collaboration with experts and interfaces;
  • Excellent process understanding and ability to translate regulatory requirements/laws into realistic business processes;
  • Excellent organization skills and ability to prioritize multiple projects amongst steady-state, day-to-day efforts;
  • Systematic, accurate, reliable and efficient way of working;
  • Proactive and initiative-taking attitude;
  • Willingness to work flexible hours (e.g. collaborations according to global time zones).


Your application
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans
 
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
 

Country: United States
Location: NJ-Whippany

A little about us:
Why Bayer? Because we’re a pioneer in the fields of human, animal, and plant health. Because we invent solutions that will create a sustainable future for our planet. Because a career with Bayer means you can put your passion into practice and make an impact.

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