At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

In this exciting role as a Compliance Specialist within the Enterprise Field Corrective Action (FCA) and Product Hold Order (PHO) organization, you 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 Medtronic. 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.

Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.

Responsibilities may include the following and other duties may be assigned.

• 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 MDT 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
• Ensures FCA documents and records are maintained with accuracy and in compliance with good documentation practices and record retention requirements.
• Identifies, leads, and implements continuous improvement projects to increase effectiveness, efficiency, and compliance.
• Ensures alignment with legal and ethical standards of the organization.
• Develops, implements, administers and certifies compliance policies, procedures, and practices.
• 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.
• Enforces anti-bribery and anti-competition laws.
• Analyzes metrics and audits functional compliance program.
• Maintains current knowledge of laws for financial, advertising and marketing reporting, regulations, and industry guidance that impact the company's compliance program.

Minimum Requirements: 

• Bachelor's degree and a minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience
• Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
• May have practical knowledge of project management.

Nice to Have:

• Knowledge of Field Corrective Actions
• Project Management experience
• Knowledge of regulatory reporting
• Must be data driven
• Ability to work in a cross-functional team environment
• Understanding of Compliance standards for medical devices

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requiremen