Compliance/Audit Spec

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life In this exciting role as a Compliance Specialist for the Field Corrective Action (FCA) Scoping Team within the Enterprise Field Corrective Action (FCA)and Product Hold Order (PHO) organization, you will be responsible for supporting all Operating Units (OU) for the FCA scoping and notification process. This position involves coordination with a diverse group of stakeholders across Medtronic including Quality, Distribution, Customer Service, Manufacturing, IT, and Global Regional Partners. 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. Responsibilities may include the following and other duties may be assigned. Manage and execute 1st and 2nd attempt FCA communications for Neuroscience, Medical Surgical and Cardiovascular portfolios, with focus on physical and digital mailings in compliance with regulatory requirements. Ensure FCA documents and records are maintained with accuracy and in compliance with good documentation practices and record retention requirements. Communicate primarily and frequently with internal contacts. Contact others to share information, status, needs and issues in order to inform, gain input, and support decision-making. Track, document, and report mailing outcomes to support audit readiness and ensure closure of communication within defined timelines Support continuous improvement projects to increase effectiveness, efficiency, and compliance. 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. Must Have: Minimum Requirements Requires a Bachelor's Degree with 2-3 years of work experience in Quality or regulated industry Quality management or document control experience Capable of effectively managing multiple demands from a variety of sources Intermediate to Advanced Excel analysis experience, including use of functions such as VLOOKUP/XLOOKUP, Pivot Tables, and formulas. Nice to Have: Excellent written and verbal communication abilities. Experience with Good Documentation Practices Excellent knowledge of Excel Detail oriented and an agile learner Experience working with large sets of data Experience with FDA regulatory medical device requirements, 21CFR Part 806, Part 7; ISO 13485, Medical Device Directive Capable of effectively managing multiple demands from a variety of sources 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. DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . 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 . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. 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 (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 2 years of relevant experience, or advanced degree with 0 years of experience. 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. ‌ Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at . ‌ 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).