BD (Becton, Dickinson and Company) Director, EU/MDR/IVDR, Medical Governance in Franklin Lakes, New Jersey
Job Description SummarySummary Description
As a senior member of Global Medical Safety and Governance, this role will lead enterprise oversight of Medical Affairs requirements for the EU Medical Device Regulation/ In Vitro Diagnostics Regulation. This role will report to the Sr. Director of Medical Governance and Information.
The Director, EU MDR/IVDR, Medical Governance, will drive strategy for managing the Medical Affairs approach to compliance with EU MDR/IVDR including creating department policies, procedures and work instructions in order to facilitate consistent enterprise wide processes for EU MDR/IVDR. In addition, the role will lead the creation a governance model for this work to ensure compliance with the Medical and Clinical activities related to EU MDR/IVDR. This role will lead a network Medical Affairs/Clinical team from across the business. This team will serve as the network to ensure the procedures and processes can be leveraged across the businesses, share learnings from business experience with Notified bodies and share best practices. In addition, this role will serve as a liaison to other cross-function teams working on EU MDR/IVDR. This role will also be responsible to seek and create opportunities for efficiency for delivering Medical Affairs processes for EU MDR/IVDR.
As well as being an expert in EU MDR/IVDR, the incumbent will be expected and to collaborate with other functional and cross-function associates working on compliance with EU MDR/IVDR.
The role will collaborate with parts of the Global Medical Safety organization as well as Regulatory and Quality to ensure smooth and complete alignment of processes related to EU MDR/IVDR adverse event reporting and other EU MDR/IVDR safety activities.
The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position:
Create a framework and strategy for key Medical Affairs and Medical Safety aspects to be compliant with EU MDR/IVDR and execution of key areas where a central model would create efficiency
Integrate/create a set of control structures for Medical/Clinical EU MDR/IVDR activities including processes, procedures and associated accountabilities to ensure consistent governance and quality assurance.
Serve as a liaison to cross-functional/cross-business EU MDR/IVDR working teams to ensure appropriate Medical Affairs/Clinical representation on those teams as well as appropriate feedback to the functional activities related to EU MDR/IVDR.
Partner with Quality and Regulatory to ensure clear and appropriate alignment of processes for adverse event reporting for EU MDR/IVDR
Partner with Global Clinical Development as needed for achieving EUDAMED reporting activities.
Build and manage an operational team to execute the EU MDR/IVDR safety and governance activities. Manage EU MDR/IVDR temporary resources
Effectively communicate EU MDR/IVDR departmental strategy, metrics, and project status expectations with team members, stakeholders and Sr. Management in a timely and professional manner.
Identify opportunities for efficient work practices and continuous improvement that would support the business unit Medical/Clinical EU MDR/IVDR work (i.e. identify and manage vendor for literature searches).
Primary Work LocationUSA NJ - Franklin Lakes
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status