**Job Description Summary** **Job Description** The **Regulatory Compliance Project Manager – Standards Management** position is primarily focused on monitoring standards, regulations and guidance documents in order to ensure continued compliance to the State of the Art.   **Job Responsibilities:** _(Primary Duties, Roles, and/or Authorities)_ + Keep abreast of all relevant standards, guidelines, and regulations, and hold quarterly meetings with stakeholders to communicate changes. + Ensure gap assessments are performed by the appropriate stakeholder functions and documented per procedure. + Manage projects, as necessary, to remediate gaps/maintain State of the Art compliance. This will include: + Developing strategies to address gaps. + Organizing and leading cross-functional teams and contract resources. + Keeping schedules and, if necessary, budgets for remediation efforts. + Coordinating with other ongoing documentation efforts, such as IVDR maintenance, to ensure efficient + Completing all necessary documentation updates including, labels, IFUs, EU IVDR documentation, etc. + Coordinating with International RA team to support ROW registrations. + Coordinating change control and Notification of Change (NoC). + Provide training or deliver presentations to cross-functional groups across TCI and DS on salient regulatory topics. + Recognize potential compliance problems areas or associate ambiguity and make recommendations to resolve. + Work independently and carries out the above tasks with minimal supervision. **Education and Experience:** + B.S. degree in a scientific, health sciences or technical discipline (e.g., engineering, bioengineering, biology, chemistry). + Minimum 5 years regulatory experience and working knowledge in regulated medical device or in vitro diagnostic device companies or an equivalence combination of experience with an advanced degree. + Experience in preparing, approving and maintaining Technical Documentation and other submissions compliant with US, EU and global regulations + Demonstrated ability to lead cross-functional team to consistently to meet regulatory requirements and project timelines. + Proficient in using Microsoft Word, Excel, PowerPoint, and Project. + Strong communication (written, oral) and project management skills. + Able to handle multiple competing tasks with great attention to detail. + Able to work independently to achieve objectives on or before schedule. + Demonstrated cross-functional collaboration and teamwork skills including influencing without authority. + Comprehensive knowledge of IVD regulations and standards. + Current knowledge of European quality system standards, and requirements under EU IVDR and MDR preferred. Ability to navigate ambiguous regulatory requirements and standards interpretation. Required Skills Optional Skills . **Primary Work Location** IND Bengaluru - Technology Campus **Additional Locations** **Work Shift** 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.