Compliance Specialist

*W2 ONLY*

Compliance Specialist (6 month contract // Minneapolis, MN):

Top 3 Skills Required:

1. Problem Solving & Attention to detail
2. Strategic Thinking & Regulatory Compliance
3. Communication & Collaboration

Primary Responsibilities:

• 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 customers
• 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

Duties:

• 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 (ex. 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.

Nice To Have

• Excellent written and verbal communication abilities
• Experience developing effective written communications and executive presentations
• Experience in customer service, supply chain, or contracts
• Experience participating in product recalls/field corrective actions
• Experience with FDA regulatory medical device requirements, 21CFR Part 806, Part 7; ISO 13485, Medical Device Directive
• General knowledge of Database Systems such as SAP, Siebel, Factory Works
• Project/Program management experience with ability of managing multiple projects simultaneously