Director Medical Device Safety

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.

The Director of Medical Device Safety (MDS) leads and develops global Pharmacovigilance (PV) business processes and analyses clinical data sets related to complaint handling, regulatory reporting and clinical development for Bayer medical devices and combination products.

The Director of MDS is an expert who provides safety oversight and content contributions to design control, clinical evaluations, vigilance reporting to authorities and post-marketing surveillance for Bayer Pharmaceutical and Consumer Health medical devices and combination products worldwide.

The incumbent will serve, and represent Bayer, as the named Deputy Person Responsible for Regulatory Compliance Safety (PRRC-Safety Officer) ultimately responsible for all aspects of compliance and safety (as it relates to vigilance reporting & post market surveillance) specified under the European Medical Device Regulation 2017/745 for Bayer Pharmaceutical and Consumer Health medical devices in order to judge if the product is safe for use.

YOUR TASKS AND RESPONSIBILITIES:

• 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.

• Person Responsible for Regulatory Compliance (PRRC) Regulatory and Quality and the PRRC Offices across Consumer Health, Pharmaceuticals and Radiology.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• 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 in English.

Preferred Qualifications:

• Master’s degree in engineering or Life-science Discipline with 6 years of professional medical device industry experience OR Bachelor's Degree in Engineering or Life-science Discipline.

• 8 years of professional medical device industry experience, and at least 4 years of professional industry experience in quality management systems relating to medical devices and pharmacovigilance.

This posting will be available for application until at least November 21, 2024.

Application Period: 11/06/24 - 11/21/24 Reference Code: 832916

Division: Pharmaceuticals Location: United States : New Jersey : Whippany

Functional Area: Medical Affairs & Pharmacovigilance Position Grade: VS 2

Employment Type: Regular Work Time:

Contact Us

AddressTelephoneE-Mail

200127 Internal *8080 cnrecruiting@bayer.com

Shanghai External 400 012 2021

Job Segment: Medical Device, Compliance, Pharmaceutical, QC, Public Health, Healthcare, Legal, Science, Quality