Manager, Clinical Projects - IVDR
Posted on: 3 Jan 2021
Sparks, MD
Job Description
Job Description Summary
Reporting to the Director, Medical Affairs [and indirectly to the WW VP, Medical Affairs], the Manager, Clinical Projects IVDR (Mgr/CP-IVDR) is accountable for the achievement of key functional business objectives for IVDR remediation. The Mgr/CP-IVDR ensure functional excellence and efficiency, demonstrating expert understanding of advanced technical/scientific principles applicable to the platform/program area of focus and those of associated disciplines (such as R&D;, Quality, Business, or Project Management), and is recognized as an MA IVDR expert across units or functions.
Job Description
Duties & Responsibilities:
* Represent Medical Affairs (MA) on IVDR project teams.
* Represent Medical Affairs (MA) on IVDR management teams.
* Provide updates on IVDR remediation work to BU and corporate MA.
* Provide thorough reviews of IVDR required documentation.
* Work with cross-functional teams to address issues and gaps.
* Liaise with outside consultants as needed.
* Potentially support the department in the further understanding of IVDR requirements needed for new product development efforts.
* Responsible for direct management of contract associates, including coaching, feedback, and development.
Knowledge/Education/Experience:
* Bachelor degree required, with preferred education/experience focus in the life sciences, clinical, laboratory or other relevant technical areas.
* Education and experience sufficient to independently contribute on multi-functional project teams as a subject matter expert in platform area of focus.
* Knowledge of BD-IDS, legacy-DS, products and systems is preferred.
***This position is a minimum of 30 hr/wk***
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-PRO
Primary Work Location
USA MD - Sparks - 7 Loveton Circle
Additional Locations
Work Shift
Becton, Dickinson and Company
Franklin Lakes, NJ
Becton, Dickinson and Company develops, manufactures, and sells medical supplies, devices, laboratory equipment, and diagnostic products worldwide. The company’s BD Medical segment offers peripheral IV and advanced peripheral catheters, central lines, acute dialysis catheters, vascular care and preparation products, needle-free IV connectors and extensions sets, IV fluids, closed-system drug transfer devices, hazardous drug detection, hypodermic syringes and needles, anesthesia needles and trays, enteral syringes, sharps disposal systems; infusion pumps and dedicated disposables, medication compounding workflow systems, automated medication dispensing, automated supply management systems, medication inventory optimization and tracking systems; syringes, pen needles, and other products for diabetes care; and prefillable drug delivery systems.
Its BD Life Sciences segment provides specimen and blood collection products and systems; automated blood and tuberculosis culturing, molecular testing, microorganism identification and drug susceptibility, and liquid-based cytology systems, as well as rapid diagnostic assays, microbiology laboratory automation products, and plated media products; and fluorescence-activated cell sorters and analyzers, monoclonal antibodies and kits, reagent systems, bench-side solutions, and molecular indexing and next-generation sequencing sample preparation products, as well as clinical oncology, immunological, and transplantation diagnostic/monitoring reagents and analyzers.
The company’s BD Interventional segment offers hernia and soft tissue repair, biological and bioresorbable grafts, biosurgery, and other surgical products; surgical infection prevention, thoracic and abdominal drainage, and surgical and laparoscopic instrumentation products; peripheral intervention products; and urology and critical care products. Becton, Dickinson and Company was founded in 1897 and is based in Franklin Lakes, New Jersey.
-
IndustryManufacturing
-
No. of Employees76,032
-
Website
-
Jobs Posted597
