BD (Becton, Dickinson and Company) CME-A regulatory specialist in Caesarea, Israel
Job Description SummaryBased in CME-A, Golden-CO, this CME-A Regulatory Affairs specialist will contribute to CME-A regulatory activities for CME-A pumps and relevant disposable infusion pump sets by preparing/maintaining 510k and related regulatory documents, projects and possible international submissions.
Support the CME-A international registration/certification activities for existing and new products:
Assess regulatory compliance of the existing CME-A products portfolio and the related required activities in partnership with the concerned CME and BD functions;
Formulate and execute action plans with the various functional stakeholders to ensure that regulatory compliance is maintained or enhanced;
contribute to preparation/revision of CME-A Technical Doc.s & Int'l Reg.s as needed;
Support the business by maintaining the compliant status of CME-A products/processes with applicable international regulations;
Help CME RA Mngr in defining the regulatory strategy and performing the requested registrations, in compliance with applicable regulations and according to the communicated business needs;
Prepare the international registrations submission in partnership with the BD regional RA contacts or local distributors with regards to obtaining, changing or renewing registrations, or responding to questions from the Authorities;
Contribute to Regulatory Intelligence, assess impact of new regulations / changes in existing regulations and help determining their strategic impact.
Primary Work LocationISR CME-Israel
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.