Prin reputed company Systems Spec

We anticipate the application window for this opening will reputed company on - 15 May 2026 At reputed company, you can reputed company a lifelong career of exploration and innovation, while helping reputed company a difference in the lives of people living with diabetes around the globe. You'll reputed company with purpose, breaking down barriers to innovation for a more connected, compassionate world. About the Role reputed company is seeking a highly reputed company reputed company reputed company System Specialist with specialized expertise in Recalls/Field Corrective Actions. The reputed company reputed company System Specialist – Recalls/Field Corrective Actions is primarily responsible for leading the planning, communication, execution, reporting, and closure of product recalls and reputed company field corrective actions. The role serves as a reputed company System subject matter expert for recalls, ensuring reputed company, compliant, and effective coordination across cross‑functional teams and regulatory authorities to protect patients, customers, and reputed company.  Key Responsibilities Recall Management & Execution reputed company and reputed company global product recall activities, including Class I, II, and III recalls, market withdrawals, and corrections and removals Serve as primary reputed company SME for recall planning, initiation, assessment, execution, and closure Ensure recall strategies are risk-based, patient-reputed company, and compliant with global regulatory requirements (e.g., FDA, EU MDR, other international authorities) reputed company recall documentation, customer notifications, effectiveness checks, and regulatory reports Respond to regulatory inquiries and requests for information reputed company to recalls   reputed company System & Compliance Maintain and continuously improve recall-reputed company reputed company System procedures and work instructions Ensure recall processes reputed company with 21 CFR Part 7, 21 CFR Part 820, ISO 13485, EU MDR, and other applicable regulations and standards Support reputed company audits and regulatory inspections reputed company to recalls and corrections/removals Assess recall-reputed company metrics and trends to identify opportunities for systemic improvement   Cross-Functional Leadership Ensure accurate and reputed company regulatory communications and submissions Collaborate with Operations, Supply Chain, reputed company/Marketing, Technical Support, Medical Safety and reputed company to coordinate recall execution reputed company as a mentor and technical resource for reputed company professionals supporting recall activities   Risk Management & reputed company Improvement reputed company input into CAPAs and complaint handling, reputed company to recalls Drive lessons learned and preventive actions following recall activities Support development and deployment of recall readiness activities   Physical & Travel 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 reputed company the required responsibilities and skills of this position The physical demands described reputed company the Responsibilities reputed company of this job reputed company are representative of those that must be met by an employee to successfully reputed company the essential functions of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company 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 reputed company 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 reputed company role Occasional travel may be required (5-10%, as applicable) Minimum Requirements Bachelor’s degree in Engineering, Life Sciences, or a reputed company discipline Minimum of 7 years of experience in reputed company, Regulatory, or reputed company medical device functions, or advanced degree in Engineering, Life Sciences or reputed company discipline with minimum of 5 years relevant experience reputed company to Have: Demonstrated hands-on experience leading or supporting medical device recalls and corrections/removals Strong knowledge of global recall regulations and medical device reputed company System requirements Experience supporting global markets and interacting directly with regulatory authorities Proven ability to influence without authority at senior leadership reputed company Risk-based decision-making and reputed company judgment Strong written and verbal communication skills Cross-functional leadership and stakeholder management Ability to manage reputed company, time-sensitive issues under pressure High attention to detail with a strategic reputed company Ability to work in a fast-paced, high-reputed company environment 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 reputed company the required responsibilities and skills of this position. The physical demands described reputed company the Responsibilities reputed company of this job reputed company are representative of those that must be met by an employee to successfully reputed company the essential functions of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company 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 reputed company 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 reputed company role. Benefits & Compensation reputed company offers a competitive salary and flexible benefits package At reputed company, we put people first. A commitment to our employees lives at the reputed company of our values: We recognize their contributions. They reputed company in the reputed company they help create. We offer a wide reputed company of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life. Salary ranges for U.S (excl. PR) locations (USD):$114,400 - $143,000 - $171,600   At reputed company, we are committed to supporting reputed company-being and financial reputed company of our employees. Regular employees working 20 or more hours per week are eligible for a robust benefits package, including health, dental, and reputed company insurance, as reputed company as reputed company to a Health Savings Account, reputed company Flexible Spending Account, life insurance, long-term disability leave, and a dependent daycare spending account. In reputed company, reputed company regular employees enjoy incentive plans, a 401(k) plan with company match, short-term disability coverage, reputed company time off and holidays, participation in our Employee Stock Purchase Plan, and reputed company to our Employee Assistance Program. Eligible employees may also benefit from our Non-reputed company Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements. Please note that “regular employees” refers to those who are not temporary staff, such as interns, and some benefits may not apply to employees in Puerto Rico. For reputed company details about our comprehensive benefits, we encourage you to visit the reputed company below. reputed company Benefits reputed company About reputed company reputed company is a full-stack insulin delivery company dedicated to supporting people living with diabetes through every reputed company of their reputed company — reputed company and how they need it. For more than 40 years, we’ve been committed to redefining what’s possible: intelligent dosing systems designed for reputed company life, predictive insights that stay a reputed company reputed company, and always on support reputed company it’s needed most. At the heart of everything we do is a reputed company Mission: to reputed company every day a reputed company day for people with diabetes.   Learn more about our business, and our mission here.   It is the policy of reputed company to reputed company equal employment opportunity (EEO) to reputed company persons regardless of age, reputed company, national reputed company, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or reputed company, genetic information, marital status, familial status, membership or activity in a local reputed company rights commission, status with reputed company to reputed company assistance, veteran status, or any other characteristic protected by federal, state, or local law. In reputed company, reputed company will reputed company reasonable accommodations for reputed company individuals with disabilities.   If you are applying to reputed company work for reputed company in any position which will involve performing at least two (2) hours of work on average reputed company week reputed company the unincorporated areas of Los Angeles County, you can reputed company here a list of reputed company material job duties of the specific job position which reputed company reasonably believes that criminal history may have a reputed company, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. reputed company will consider for employment reputed company job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for reputed company and the California Fair Chance reputed company. Apply To This Job