Compliance Specialist ~ FCA

Compliance Specialist

W2 only

No C2C

Location: Mounds View MN - 4 days per week working on site

Top 3 things the hiring manager is looking for in a candidates experience:

• Problem Solving & Attention to detail
• Strategic Thinking & Regulatory Compliance
• Communication & Collaboration
  
  

Top 3 Tasks or Responsibilities in scope for this role:

• Identify FCA strategies, actions and milestones to be included in the FCA plan.
• Provide weekly FCA/projects status updates (track, execute and report on) to internal and external customers3. Assist in the response to regulatory inquiries related to Field Corrective Actions (FCAs).
  
  

Education Required: Bachelor's degree with 4 years of work experience in Quality, Compliance and/or medical/pharma regulated industry OR Advanced degree with 2 years of work experience in Quality, Compliance and/or medical/pharm regulated industry.

A Day in the Life For Field Corrective Action (FCA) Compliance Specialist:

• Oversee the global execution of the global FCA plans to ensure adherence to plan actions and milestones by working cross functionally and with international partners.
• Provide weekly FCA status updates.
• Draft FCA status updates to regulators as needed to the FDA or regulatory compliance entity.
• Lead cross functional teams to facilitate the development, review and approval of global Field Corrective Action (FCA) Plans.
• Facilitate the development of FCA materials (letters, presentations, etc…) to effectively communicate relevant information to appropriate customers (e.g. health care providers, risk managers, hospital personnel, patients) and Medtronic field personnel to mitigate patient risks.
• Identify FCA strategies, actions and milestones to be included in the FCA plan.
• Work with regulatory contacts to identify, plan and coordinate notifications to regulatory bodies and respond to regulatory and field inquiries in a timely fashion.
• Analyze current business processes and identify best practices to develop improved, standardized processes for Product Hold Orders (PHO) and FCAs.
• Coordinate with different stakeholders in supply chain and quality to initiate, execute, reconcile and close Product Hold Orders.
• Assist in the response to regulatory inquiries related to Field Corrective Actions (FCAs).
• Ensure that the FCA plan follows all applicable internal, corporate and regulatory standards or requirements.
• Provide backroom support for internal and external inspections.
• Provide backroom support for CAPA's and process improvement projects.
• Maintain data and prepare reports, presentations, proposals and status updates for management.
• Performs other duties as assigned. Responsibilities may also include the following and other duties may be assigned.
• Develops, implements, administers and certifies compliance policies, procedures, and practices.
• Ensures alignment with legal and ethical standards of the organization.
• Provides compliance advice, investigates complaints and verifies deficiencies are corrected.
• Develops employee communication and training programs that focus on the elements of a companywide compliance program.
• Analyzes metrics and audits functional compliance program.
• Maintains current knowledge of laws for regulations, and industry guidance that impact the company's compliance program.
  
  

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