Sr. Compliance Specialist-1st Shift at Medtronic in Mounds View, Minnesota

Job Description:

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 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):$82,400.00 - $123,600.00

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.

At Medtronic, most positions are posted on our career site for 3-7 days.