Job Description

Compliance Specialist (24 month contract // Northridge, CA):

Must be on-site at the Northridge Campus in CA in a hybrid capacity 2 days a week

Top 3 Required Skills:

1. Writing skills- preferably technical writing
2. Experience working with FCAs in a Medical Device setting
3. Proficiency in EXCEL, including pivot tables, V-Look Ups, functions, etc.

Top 3 Tasks in scope for this role:

1. Report Writing (Taking information, summarizing the information, and putting into a report)
2. Reconciling Data sets (being comfortable working with lots of data and validating the information)
3. Working cross-functionally to gather missing data from internal stakeholders (phone calls, emails, etc.)

Education Required: Bachelor’s Degree

Years’ Experience Required: 3+ years of experience

Description:

In this role as a Compliance Specialist within the Enterprise Field Corrective Action (FCA) and Product Hold Order (PHO) organization, candidate will be responsible for the execution and closure of Field Corrective Actions (FCAs) globally. Job duties specifically include project management of FCA activities (e.g. notifications, retrievals, software updates), reconciling large amounts of data, drafting, reviewing, and submitting regulatory reports, and reporting on daily, weekly, and monthly metrics. This position involves coordination with a diverse group of people across the client’s organization. The individual for this role will need to work independently and as a team player with the ability to use sound judgement and work through ambiguous situations utilizing peers and leadership for assistance as appropriate. The ideal candidate would have experience with Field Corrective Actions, reconciling data sets, and a strong knowledge of compliance standards.

Duties:

• Provides project or program support to a functional group or business process
• Monitors project status and timetables
• Gathers and compiles information for regulatory reports
• Provides reconciliation of data to ensure all requirements/evidence is available
• Draft, coordinate review, and submit regulatory reports
• Ensure compliance of FCA files to regulations and client’s processes; identifying gaps and following up with OUs/regions/applicable owners to resolve
• Compiling final FCA file and all supporting evidence according to processes and regulations

Required Knowledge and Experience:

• Requires a Bachelor’s Degree and minimum of 3 years of relevant experience, or advanced degree with 2 years of experience.

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