Sr. Compliance Specialist – 1st Shift

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 companys compliance program.

Minimum Requirements:

Bachelors 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 device s

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 (https://www3.benefitsolver.com/benefits/BenefitSolverView?pagename=signon&conum=30601&coaffid=medtronic)

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 (http://www.medtronic.com) .

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.

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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.

We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.

We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will…

Build a better future, amplifying your impact on the causes that matter to you and the world

Grow a career reflective of your passion and abilities

Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning

These commitments set our team apart from the rest:

Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.

Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.

Better outcomes for our world . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.

Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. Youre shaping the future of healthcare technology and defining the next generation of breakthroughs in care

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.

For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .

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