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Job Description SummaryDrive and manage the development of clinical evaluations, with supportive literature reviews and analyses and drive the generation and updating of Clinical Evaluation Reports (CERs) for EU MDR compliance. The Sr. Manager will provide strategic input and work cross-functionally with regulatory affairs, research and development and quality departments as well as post-market surveillance for the generation of clinical evidence for submission to regulatory authorities. The individual will liaise between their CER vendor and internal teams to ensure the coordinated and efficient completion of all medical aspects of the requirements for the technical files related to MEDDEV/MDR compliance. The Sr. Manager will ensure timely annual updates of CERs for existing products and the generation of new product CERs.Job DescriptionOrganize and lead the projects needed to ensure compliance with the new MDR regulation and an efficient response from the business, regulatory and evidence generating functions.
Coordinate and lead efforts to develop and maintain reports and data sets (including Clinical Evaluation Report and Risk Management Documentation deliverables), to support adherence to international regulations and reporting requirements.
Serve as the subject matter expert to support the EU MEDDEV/MDR program for the medical & scientific content of internal product documentation and regulatory submissions for new products and for renewals.
Partner globally with and provide strategic input to Medical & Regulatory Affairs teams for clinical activities for the MEDDEV/MDR program and evidence generation needs.
Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs, Marketing to ensure accurate and appropriate input into the Clinical Evaluation Report sections.
Drive post-market surveillance (PMS) activities by leading systematic literature reviews (e.g., screens articles against inclusion / exclusion criteria, interpreting study results, synthesizing literature and preparing reports) for Infusion device / system products.
Ensure the Clinical Evaluation Report documents are written in accordance with procedures, internal and external guidelines and applicable regulations.
Perform MAUDE database searches and reviews and summarizes content.
Author and drive the generation of Risk/Benefit Analyses, Known Use Error Reports or other relevant Medical Affairs documents required for regulatory deliverables.
To be successful in this role, you require:Knowledge of IV therapy and infusion device systems
Risk management and clinical workflows experience related to the use of infusion device systems
Solid clinical, scientific background and proficient writing skills, to manage the production of Clinical Evaluation Plans and Reports for BD Infusion Device Products and Systems.
Excellent communication skills, including the ability to interpret, assimilate and author clinical documents that meet complex international regulatory and safety standards
Excellent time management skills with ability to meet deadlines.
Position requires ability to work in a home or office environment with connectivity to the internet.
Proficiency in MS Office with expertise in Microsoft Word, Excel and use of templates and formatting.
Position requires overnight travel; likely not to exceed 15 to 20% of time, annually.
Education and experience required:Professional clinical degree (Nursing or Pharmacy)
Medical Devices experience
Project and CRO Vendor Management experience
Knowledge of Regulatory pathways, EU MEDDEV/MDR and MEDDEV related to pre- and post-market evidence needs
Prior clinical experience with BD product categories highly desired
Prior functional experience with quality systems and risk management processes highly desired.
Practice experience as a licensed healthcare provider highly desired
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, or any other protected status.#LI-PROPrimary Work LocationUSA CA - San Diego Bldg A&BAdditional LocationsWork ShiftBecton, 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, or any other protected status.
Vacancy expired!