Job title: Regulatory Affairs Analyst
Company: CR Bard
Job description: Job Description Job Description Summary Job Description DEO Analyst supports the Business Process Lead (BPL) in the operation of the DEO Management Program for the business unit. The DEO Analyst is responsible for the coordination and tracking of in
Job Description Job Description Summary Job Description DEO Analyst supports the Business Process Lead (BPL) in the operation of the DEO Management Program for the business unit. The DEO Analyst is responsible for the coordination and tracking of information and assignment progress between the Central Standards Committee, BU Oversight Committee, and DEO Owners Bachelor’s degree in life Science, technical discipline, or business administration Professional Experience A minimum of 2 years working in the medical device industry or other regulated industries. Job Responsibilities Gap Impact Assessment Monitor for DEO changes using subscription tools (e.g. IHS) Notify stake holders of change (i.e., BPL, BU DEO Oversight Committee, Global Standards Coordinator), Identify BU DEO Owner(s) and functional SMEs in consultation with Sr Mgt Provide copy of redlined version, if available or easily generated. Schedule meetings between stake holders, owners and SMEs as requested for delegation of assignments, planning, or general communication updates. Facilitate workflow of Horizontal DEO between BDX and MDS Verify or assist in collating SME inputs and routing of the Gap Impact Assessment and Mitigation Plan form, (e.g. CPR-047 FRM 1 or equivalent) DEO List for Monitoring/Owners/Function SMEs Maintain the MDS page within the BDX DEO monitoring list. Monitor for DEO additions to BU LR2T (or equivalent tool) and update MDS DEO monitoring list. Organize Oversight Committee to identify BU DEO Owner(s) and function SMEs Maintain MDS List of DEO Owners & Function SMEs Initiate Gap Impact Assessment of added or revised DEO Standard Development Organizations (SDO) Maintain MDS portion of BDX master list of associates participating on SDO committees and those shadowing/training pre-placement. Tracking and Reporting Track completion of assessments, extension requests and mitigation commitments. Send reminder emails prior to due dates of tracked items. Provide monthly metrics on the various aspects of the DEO Management Program as needed Other Support pilot testing of e-workflow tools Field general how-to questions from associates Work closely with BDX DEO Analyst to streamline BDX/BU coordination efforts wherever possible. Support preparation and presentation of training materials and training events Knowledge and Skills Knowledge Experience with Medical Device New Product Development and design control Recognition of standards and regulations and their importance in a regulated industry Understanding of concepts of ‘state of the art’ and standards compliance Skills This position requires high proficiency in: Organization and time management Communication through various channels and formats Documentation and adherence to Good Documentation Practices Attention to detail Ability to rapidly build knowledge and understanding of BD DEO management program, policies, and roles of affiliated associates Experience coordinating multifunctional teams and multiple projects simultaneously Desired / Additional Skills & Knowledge (Not essential to the job but will be an advantage to possess) Audit experience Experience with Change Control
Location: Bangalore, Karnataka
Job date: Wed, 16 Mar 2022 23:32:41 GMT
Apply for the job now!