• Lead the qualification, evaluation, and continuous monitoring of all third-party contract manufacturers. • Review and verify co-man compliance with FDA cGMP , NSF, and other certification bodies. • Ensure each manufacturing partner operates within approved quality systems and meets Blueroot Health’s production, testing, and documentation standards. • Maintain and update approved supplier/manufacturer qualification files, audits, and risk assessments. • Act as primary Blueroot Health compliance liaison for co-man quality questions, deviations, documentation requests, and investigative follow-up. • Review, manage, and approve all raw material specifications, blended batch specs, in-process specs, and finished product specifications. • Ensure all raw materials, intermediates, and finished goods have validated and complete specification sheets aligned with regulatory expectations. • Oversee receipt and verification of Certificates of Analysis (CoAs) from co-mans, ensuring completeness, accuracy, and compliance with specifications. • Maintain active, accessible, organized files for all specifications, CoAs, and quality-related documentation. • Prepare, manage, and review Master Manufacturing Records (MMRs) and Batch Production Records (BPRs) to ensure compliance prior to manufacturing release. • Review all batch documentation from co-mans for completeness, deviations, testing results, and non-conformance investigations. • Approve release of finished goods for shipment to Blueroot Health distribution centers once all quality requirements are met. • Ensure all documentation required for dietary supplement cGMP compliance is current, accurate, and audit ready. • Organize and support regulatory and certification inspections (FDA, NSF, State/Federal agencies). • Maintain facility registration documentation (FDA site registration, state registrations, third-party certifications). • Manage and update Standard Operating Procedures (SOPs), training records, and quality procedures related to co-manufacturing compliance. • Maintain active files for deviations, QC investigations, OOS reports, CAPAs, and other quality events. • Coordinate with co-mans to ensure investigations are completed thoroughly and on time. • Verify lab results meet product specifications; follow up when results deviate or require deeper investigation. • Analyze quality and performance data from co-mans to identify trends, risks, or process improvement opportunities. • Maintain records and summaries for customer complaints requiring QA review, including Adverse Events (AEs) and Serious Adverse Events (SAEs).

• Architect of the compliance system: You continuously develop our company-wide Compliance Management System and build a stable foundation that enables growth and provides security. • Guardian with foresight: You ensure our management can sleep calmly — because you identify risks early, manage them confidently, and maintain a stable, compliant foundation. • Project manager & coordinator: You keep an overview of all compliance processes, manage projects independently, and ensure smooth collaboration with internal and external stakeholders. • Designer with clarity: You think structurally, act efficiently, and develop processes that are clear, lean, and effective. • Bridge-builder: You connect departments, understand diverse perspectives, and translate complex requirements into clear, actionable measures. • Solution-oriented partner: You act as a sparring partner for executives and colleagues, advise on equal footing, and work with them to find practical paths to compliance. • Learning architect & driver of initiatives: You design training that inspires — interactive, practice-oriented, and engaging. You create learning environments where colleagues not only listen but also think along, empathize, and contribute.

Role Description The Compliance Specialist is responsible for assisting in the oversight of an enterprise-wide Corporate Compliance Program to detect, correct and prevent violations of Federal and State laws, rules, or regulations. The position is responsible for assisting the Chief Compliance Officer with implementing, maintaining and monitoring the compliance program elements that includes: - Investigations - Policies - Standards - Workforce training - Awareness of general compliance requirements - Reporting and investigating concerns of FWA This position will help in the evaluation of the FWA and Compliance Program. The Compliance Specialist will report to the Chief Compliance Officer in the investigation of suspected violations and in the development and oversight of corrective action plans. The Compliance program involves a continuous process of adhering to legal, ethical and professional standards applicable to AllCare employees, Board of Governors, providers, contractors, temporary employees, consultants and subcontractors. The Compliance Specialist will cooperate and assist in submitting appropriate referrals and case documentation to enforcement agencies such as: - Medicaid Fraud Unit (MFCU) - Office of Program Integrity (OPI) - Office of Inspector General (OIG) - Department of Justice (DOJ) - Centers for Medicaid and Medicare Services (CMS) - Oregon Health Authority (OHA) Qualifications - Bachelor's degree (BA) from a four-year college or university; or one to two years related experience and/or training; or equivalent combination of education and experience in criminal justice, fraud management, or healthcare administration. - Work experience in investigations, with certification as a Certified Fraud Examiner (CFE), Accredited Healthcare Fraud Investigator (AHFI), Certified Professional Coder (CPC), Certification in Healthcare Compliance (CHC), or other fraud-related certifications. - Knowledge of CPT Codes, ICD-10 Codes, Medicare Guidelines, OIG Work Plan priorities, Oregon Health Plan Contract Requirements, HIPAA, FWA and Compliance CFRs, Regulations and Statutes. - Valid Oregon Driver’s License and vehicle insurance. - Certification in Healthcare Compliance (CHC). Requirements - Ability to perform essential job duties with or without reasonable accommodation and without posing a direct threat to safety or health of employee or others. - Ability to read, analyze, and interpret the most complex documents. - Ability to respond effectively to the most sensitive inquiries or complaints. - Ability to write speeches and articles using original or innovative techniques or style. - Ability to make effective and persuasive speeches and presentations on controversial or complex topics to top management, public groups, and/or boards of directors. - Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. - Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. - Job requires specialized computer skills. Must be adept at using various applications including database, spreadsheet, report writing, project management, graphics, word processing, presentation creation/editing, communicate by e-mail and use scheduling software. - Ability to define problems, collect data, establish facts, and draw valid conclusions. - Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and work with several abstract and concrete variables. Benefits - May require the use of personal vehicle for local travel (subject to mileage reimbursement). - May require the use of a personal cell phone (cell phone stipend applicable). Company Description The employee must occasionally lift and/or move up to 10 pounds. While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel and talk or hear. The employee is occasionally required to stand; walk and reach with hands and arms. The noise level in the work environment is usually moderate. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this job. The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties. Monday - Friday 8:00AM-5:00PM with a 1 hour lunch and two 15 minute paid breaks.

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 We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Work with us to incentivize better patient care and partner across the industry to make healthcare more affordable and accessible. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide. This role supports the Regulatory Affairs (RA) team in managing regulatory submissions, documentation, and compliance activities for medical devices. The position works closely with RA Managers, business partners, and international teams to ensure products meet local regulatory requirements, maintain registrations, and support the lifecycle of regulatory projects across Latin America. It combines project coordination, documentation management, and cross-functional collaboration to ensure regulatory processes run smoothly and efficiently. This position will be a remote position in Bogotá. Responsibilities may include the following and other duties may be assigned: - Support preparation, submission, and follow-up of regulatory applications, registrations, and approvals with health authorities - Maintain and update regulatory documentation, databases, and tracking tools for ongoing projects - Coordinate with internal stakeholders (business units, regulatory teams, and global partners) to gather information for submissions - Assist with regulatory compliance activities including document management, translations, and approval notifications - Monitor regulatory processes and follow up on timelines, submissions, and requests from government agencies Required Knowledge and Experience: - Bachelor’s degree in biomedical engineering, pharmacy, life sciences, or related discipline - Basic understanding of regulatory affairs processes and medical device regulations - Strong organizational and project coordination skills - Excellent written and verbal communication skills to interact with cross-functional teams - Ability to manage multiple tasks, maintain documentation accuracy, and work with regulatory databases or tracking tools - Fluent in english 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.  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). 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