QARA Intelligence Specialist
QARA Intelligence Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Monitor the US regulatory and global standards landscape to identify new and changing regulations guidances and
standards that impact Teleflex products and processes.
Engage with regional regulations and standards providers business units and manufacturing sites to maintain a
state of compliance with applicable standards and regulations including maintenance of the external documents
watchlist.
Engage assigned technical review board and extended technical review board members to ensure appropriate
communication on potential impact to products and processes leading to timely processing of new and changing
regulations and standards.
Engage assigned subject matter experts to complete impact assessments in a timely manner and manage
collaboration across SMEs to complete gap and impact assessments holistically and consistently.
Build and lead project teams across business units and functions to manage assessment of impact and alignment on
implementation planning in a manner that is focused on problemsolving and ensuring continued compliance.
Analyze trend and report on standards and regulations management process on a periodic basis as determined by
Quality and Regulatory (QARA) Management including identifying changes that may have impact to products or
QMS that may be escalated at management review meetings.
Create and deliver training materials in support of the Standards and Regulation Management process when
required. Engage with stakeholders to ensure understanding of the process and requirements.
Adhere to and ensure compliance with Teleflex’s Code of Ethics all Company policies rules procedures and
housekeeping standards.
Complete the role outlined in the relevant processes
o Acts as point of contact to receive standards updates from the standards subscription service and regulation
updates from the Regional Regulations and Standards Provider
o Completes forms required for the process
o Works with members of the Technical Review Board and Extended Technical Review Board to document the
preliminary applicability assessment and Subject Matter Experts (SMEs) across BUs and Functions
o Identify potential impact to global QMS documents and work with global QMS document owners to complete
the impact assessment.
o Provides notification to SMEs who are responsible for performing gap and impact assessments for their
respective BUs or functions.
Processes updated gap and impact assessments in the electronic document management system (e.g. Global Agile)
as applicable. This includes archiving documents that may have been approved outside of Global Agile.
Leads technical review meetings for updated gap and impact assessments in collaboration with assigned subject
matter experts in order to confirm the completed gap and impact assessments capture the full scope of impact and
implementation
Maintains External Documents Watchlist in collaboration with regional regulatory and the business units and ensures
that Teleflex has adequate monitoring of all standards and regulations that are applicable
Works with Management Representatives at Teleflex facilities in scope of this work instruction to provide information
that may be required as pertinent to their location and compiles and reports on process metrics for data review
meetings
Employment Type
Full Time
Company Industry
Key Skills
- All-Source Intelligence
- Military Intelligence
- GIS
- ICD Coding
- Intelligence Experience
- Military Experience
- Analysis Skills
- Microsoft Powerpoint
- Joint Operations
- Intelligence Analysis
- Leadership Experience
- Writing Skills
