Principal Compliance & Audit Specialist - JR (Finance)

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 Principal Compliance Audit Specialist role, you will be responsible for managing assigned projects and working with internal customers and stakeholders to achieve defined Internal Audit and Compliance objectives.
A Day in the Life

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

• Plans, executes, and reports on internal audits in accordance with regulatory requirements and international standards, which may include US and international regulatory agencies / authorities.
• Analyzes audit data and presents findings to management and/or regulatory bodies in support of Corrective Action Plans, which may include coaching business partners on compliance gaps, data, and/or resulting corrective actions.
• Interprets and implements applicable regulations as they apply to products, processes, practices, and procedures.
• May counsel stakeholders about these requirements as necessary.
• Ensures compliance with internal and external regulatory agencies, which may include investigating and resolving compliance violations, questions, or concerns.
• Develops and implements programs, communications, and/or training designed to increase employee awareness and knowledge of compliance policies and/or processes.
• Remote

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects - from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

MUST HAVE (Minimum Requirements)

Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.

Requires a Bachelor degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. • 214.2(h)( 4)(iii)(A) and minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience.

NICE TO HAVE (Preferred Qualifications)

• Understanding of global regulatory requirements for medical devices, including FDA regulations (e.g., 21CFR Part 820), ISO 13485, ISO 14971, Medical Device Directive, MDSAP, QMSR and European Medical Device Regulation.
• Technical experience in one or more of the following areas: design controls, CAPA methodologies, sterilization, microbiology, active medical devices, MDR, corrections and removals, pre/ post-market, IVDR, animal and human tissue, SaMD, SiMD, Product Security.
• Experience defining, driving, and implementing process improvement efforts.
• Strong organizational skills and time management skills
• Ability to support multiple projects, prioritize, conduct team meetings, and meet project deadlines.
• Excellent communication (oral and written), presentation, and interpersonal skills.
• Proven experience in achieving results through influence management and motivating teams

DIFFERENTIATING FACTORS

Autonomy: Seasoned individual contributor.
Works independently under limited supervision to determine and develop approach to solutions.
Coaches and reviews the work of lower level specialists; may manage projects / processes.

Organizational Impact: May be responsible for entire projects or processes within job area.
Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties .
Makes improvements of processes, systems or products to enhance performance of the job area.
Analysis provided is in-depth in nature and often provides recommendations on process improvements.

Communication and Influence: Communicates with senior internal and external customers and vendors.
Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.

Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area.
May manage projects, requiring delegation of work and review of others' work product .

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.

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

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 95,000+ 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.

If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.