Responsible for planning, executing, and closing Field Corrective Actions (FCAs) in compliance with international regulations and maintaining accurate records of FCA activities.

Job Requirements:

Experience with FCA planning, execution, and closure in regulated industries. Knowledge of FDA, EU MDR, ISO 13485, and other international regulatory requirements. Experience in maintaining records of field corrective actions, product recalls, and customer notifications. Ability to collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, R&D, Manufacturing, and Customer Service. Familiarity with preparing and submitting FCA reports to regulatory agencies.

Preferred Skills:

Strong knowledge of enterprise FCA processes and remediation support. Experience working with internal stakeholders and external partners to address FCA-related matters.

Job Responsibilities:

Prepare input for Product Bounding of identified FCAs. Develop strategies for FCA planning, execution, and timely closure. Ensure FCA activities are compliant with international regulations, including FDA and EU MDR. Maintain comprehensive records of field corrective actions and product recalls in compliance with regulatory standards. Provide guidance and leadership to cross-functional teams on FCA-related activities. Collaborate with the Enterprise FCA team to prepare and submit necessary reports to regulatory agencies. Support remediation efforts and ensure effective communication of corrective actions with internal and external stakeholders.

Pay Details: $40.00 to $54.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
The California Fair Chance ActLos Angeles City Fair Chance OrdinanceLos Angeles County Fair Chance Ordinance for EmployersSan Francisco Fair Chance Ordinance