Compliance Specialist at Medtronic in Minneapolis, Minnesota

Job Description:

We anticipate the application window for this opening will close on - 22 Nov 2024

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 on the Enterprise Field Corrective Action (FCA) Execution Team, you will be responsible for supporting the Cardiovascular and Neuroscience Portfolios in execution of Field Corrective Actions (FCA's) globally.

Job duties specifically include support of Cardiovascular and Neuroscience FCA Execution Portfolio Leads in managing execution of select FCAs, ensuring robust FCA documentation, including drafting and submitting monthly regulatory reports and documenting and retaining evidence of completion of FCA activities (e.g. notifications, retrievals, software updates), reporting on metrics, and escalating risks.

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, in complying with Quality regulations, requirements, and standards, and in reconciliation of data sets.

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.

• Prioritizes patient safety and regulatory compliance by acting swiftly in collaboration with cross functional partners to ensure timely FCA execution


• Monitors FCA execution status and timetables


• Gathers and documents evidence of FCA task completion


• Ensures FCA documents and records are maintained with accuracy and in compliance with good documentation practices and record retention requirements.


• Gathers and compiles information for regulatory reports


• Draft, coordinate review, and submit regulatory reports


• Supports continuous improvement projects to increase effectiveness, efficiency, and compliance.


• Ensures alignment with legal and ethical standards of the organization.


• Enforces antibribery and anticompetition laws.

Differentiating Factors:

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  Autonomy: Works independently with general supervision on larger, moderately complex activities / assignments


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  Organizational Impact: Sets objectives for own work to meet the objectives of the Cardiovascular and Neuroscience FCA portfolios, may have some involvement in cross functional assignments


• 
  Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.


• 
  Communication and Influence: Communicates primarily and frequently with internal contacts. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.

• Required Knowledge and Experience:
  
  
  
  • Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience.
  
  
  • Requires a Baccalaureate degree and minimum of 2 years of relevant experience, or advanced degree with a minimum of 0 years relevant experience.
  
  
  
  

Must Have: Minimum Requirements

Include: To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

• Bachelor's degree and minimum of 2 years of relevant experience or advanced degree with minimum of 0 years of relevant experience.


• Capable of effectively managing multiple demands from a variety of sources

Nice to Have

• Excellent written and verbal communication abilities.


• Experience with FDA regulatory medical device requirements, 21CFR Part 806, Part 7; ISO 13485, Medical Device Directive.


• Experience supporting internal and external audits


• Experience supporting continuous improvement projects

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 requirements that may be specific to each role.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$68,000.00 - $102,000.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 90,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here .

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.