Associate Director Device Vigilance

Whippany, NJ, United States
Apr 16, 2018
Required Education
Masters Degree/MBA
Position Type
Full time

Your tasks and responsibilities

The primary responsibilities of this role, Associate Director Device Vigilance, are to:

  • Generate concepts and actively implements medical device standards in accordance with corporate policy and applicable global regulations for complaint handling, global reporting, and trending;
  • Manage medical devices related process document content to ensure conformity with worldwide regulations and Bayer processes;
  • Represent Pharmacovigilance (PV) in Quality System Document meetings and leads document compilation teams, as medical device expert;
  • Conduct trend evaluation and analysis of safety event data sets associated with the device user interface across Consumer Health and Pharmaceutical product portfolios;
  • Be responsible for PV input into user requirements, design validation, device risk assessment and Post-Market Surveillance of medical devices;
  • Be a Pharmacovigilance representative responsible for Post-Market Surveillance activities and contributions related to safety + device user interface across various product portfolios;
  • Provide PV counsel as medical device subject matter expert during internal and external audits (including Notified Body Audits) and National Competent Authorities inspections;
  • Interpret global regulations for execution and recommends modification to operational procedures to ensure continued compliance and state of the art industry conformity;
  • Actively drives continuous improvement of medical device related processes including active, solution based and 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 four years of professional medical device industry experience in a R&D position OR Bachelor's Degree in Engineering or Life-science Discipline with six years of professional medical device industry experience in a R&D position;
  • Demonstrated, working 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 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 to diagnose related safety risks;
  • Good scientific application of statistical methods used for evaluating complaint trends and establishing thresholds for routine trend reviews (e.g. human factor, malfunction, user interface and user safety);
  • Solid analytical skills, data collection/ management and reporting skills;
  • Able to develop and administer management information systems for track and trending;
  • Experienced in project management with demonstrated success in effectively working in teams;
  • Excellent presentation and writing skills (summary reports, evaluations, authority presentations, etc.);
  • Strong ability to work collaboratively within a global, matrixed organization;
  • Self-starter with proven ability to successfully work with minimal supervision;
  • Strong sense of responsibility, balanced decision making, and high ethical standards;
  • Strong communications skills in English (written and spoken);
  • Excellent organization skills and ability to prioritize 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