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Manager, Global Regulatory Operations

Apply Now Job ID R-329959 Date posted 02/07/2019

Job Description Summary

In this newly created position reporting to the Director, Regulatory Operations, Systems, the Manager, Regulatory Operations is responsible for leading the compilation of compliant electronic submissions to global regulatory health authorities including but not limited to managing BD’s processes and systems supporting the development, implementation and maintenance of processes and systems for enterprise document management.

Job Description

  • Job Responsibilities:
  • Design Workflows, Automation procedures and Reports for various Regulatory Management Systems.
  • Responsible for handling design, automation, troubleshooting and analysis of multiple projects in Regulatory Systems in a regulated environment.
  • Responsible for reviewing and approving validation deliverables of GxP regulated computerized systems to ensure full compliance with Health Authority regulatory requirements and adherence to company policies and procedures by supporting computer validation projects and base business support teams.
  • Thorough understanding of Regulatory and Quality Management Processes combined with strong computer and technology skills to achieve desired outcomes.
  • Develop and implement SOPs/processes, working practices, workflows, quality controls, and compliant document management and submissions principles.
  • Conduct routine oversight of the strategic and operational document development of regulatory records and other GxP documentation intended for submission to Health Authorities.
  • Maintain and manage new technology platforms, including document management and publishing systems.
  • Ensure quality of submission documents and published output including formatting, navigation and dataset completeness.
  • Support the authoring, review, approval, transfer, and archival of regulated documentation.
  • Provide support in the development of regulatory compliance strategies in targeted areas to ensure country and region-specific regulations and local environments are identified and addressed.
  • Maintain familiarity with current and future global regulatory submission standards.
  • Strong leadership and influence management skills and the ability to function effectively in large matrix organizations.
  • Strong project management skills.
  • Excellent analytical and problem-solving skills
  • Expertise in development of validated enterprise regulatory IT systems
  • Sound working knowledge of the global regulatory environment
  • Strong coaching and mentoring skills
  • Ability to effectively communicate complex issues and programs to all levels of the organization.
  • Significant experience and knowledge of document management and publishing systems and tools
  • Thorough understanding of Regulatory and Quality Management IT processes (eg. SDLC, CSV) combined with strong computer and technology skills to achieve desired outcomes

Leadership:

  • -Proven ability to earn the trust of leaders within the organization, including senior leaders
  • -Proven ability to mobilize, motivate and direct a matrix team towards a common vision and common set of objectives
  • -Proven ability to resolve conflict (striving for win-win outcomes)
  • -Proven ability to deliver tough messages in a professional manner
  • -Proven ability to act independently and to execute with limited information and ambiguity

Project management responsibilities included but not limited to:

  • -Develop and manage project timelines

    -Facilitate user requirements gathering sessions

    -Collaborate with IT in the development of the system design and coordinate development activities for system integration points

    -Ensure application is thoroughly tested and validated to meet user requirements

    -Determine ways to collect, reconcile, migrate and store regulatory documentation

    -Develop and deploy end user training

    -Develop post go-live support structure

    -Gather new enhancements request for continuous process and system improvements

    -Determine user license requirements for systems

    -Manage and plan future system release cycle

Education and/or Experience:

  • Bachelor degree in science or health related discipline (advanced degree preferred)
  • Minimum of 6 years of professional experience of medical devices with 5 years of relevant Regulatory Systems ownership/management or IT experience(.such as SFDC, Document Management systems, Qlikview and SAP).
  • Deep understanding of interpreting business processes into user requirements and system capabilities
  • Knowledge of software development lifecycle for validated systems
  • Regulatory eCTD/501(K)/PMA publishing knowledge and experience.
  • Knowledge and experience with enterprise document management systems and functionality (DMS).
  • Knowledge of U.S. and international regulations including cGMP, GCP, GLP, ICH guidance documents.
  • Knowledge and understanding of global regulatory submission formats, industry standards, guidelines, validation concepts, and publishing best practices including eCTD/501K format and registration tracking.
  • Ability to work with high level contacts and exposure to sensitive information necessitating considerable use of tact, diplomacy, discretion and judgment.
  • Detail-oriented with the ability to promptly assess documents and data for accuracy as well as consistency
  • Strong interpersonal skills with the ability to influence others in a positive and effective manner
  • Strong team and customer focus
  • Working knowledge of medical device and IVD development, approval process and life-cycle
  • Excellent communication skills; both oral and written
  • Prior experience in developing and maintaining medical device and IVD documents throughout their lifecycle.
  • Broad knowledge of the med tech industry.
  • Demonstrated ability to contribute to a continuous learning and process improvement environment.
  • #LI-TECH

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

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