Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Senior Manager, Medical Device Safety
YOUR TASKS AND RESPONSIBILITIES
The primary responsibilities of this role, Senior Manager Medical Device Safety PV, are to:
Provide content input to Project teams for designing, planning and conducting analyses of safety data for the assessment of medical device safety and performance;
Provide content input to the post-marketing surveillance (PMS) program activities including, PMS system documentation, PMS planning and report management;
Provide content input, develop and execute PMS trending methodologies, analysis, written contributions and trend report preparations;
Provide New Product Development contributions to design control for medical devices throughout the AS process;
Make recommendations based on integrated trending analyses and generate presentations in collaboration with program teams;
Support standardization of database structures and implement standard processes required for integrated trending activities;
Be responsible for monitoring, analyzing and applying trending methodologies to the vigilance data submitted to Health Authorities (e.g MDRs);
Be responsible for the production and accuracy of medical device analysis and interpretation of results;
Be responsible for the orchestration of PMS program activities under the ownership of PV MDS.
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:
Bachelor's Degree in Engineering, Mathematics or Life-science Discipline with 4 years of professional experience in medical devices or similar sector;
Working understanding of medical device regulations and industry standards globally specifically 21 CFR 820, 803, ISO 13485, and euMDR 2017/745;
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);
Able to develop and administer management information systems for track and trending;
Strong analytical and technical skills that include data collection, analysis and required report generation;
Strong communication skills and ability to work both, independently and cross-functionally with Quality, Regulatory, Marketing and other applicable functions within the business;
Demonstrate ability to think outside the box and make recommendations for improvement;
Good presentation and writing skills (summary reports, evaluations, etc.);
Fluent in English.
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. 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. Location: United States : New Jersey : Whippany Division: Pharmaceuticals Reference Code: 166545 Contact Us + 1 888-473-1001, option #5
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