At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As Sr. Compliance Specialist, you will be trusted to provide QA oversight to Clinical Evaluations, Clinical Operations, Medical Safety, and other R&D Centers of Excellence to ensure that global clinical evaluations and clinical studies are conducted by Alcon are in compliance with applicable regulations including EU MDR, FDA, ISO etc. guidelines and quality standards established by the relevant regulatory agencies at our Main Campus in Fort Worth, TX. POSITION PURPOSE Provides QA oversight to Clinical Evaluations, Clinical Operations, Medical Safety, and other R&D Centers of Excellence to ensure that global clinical evaluations and clinical studies are conducted by Alcon are in compliance with applicable regulations including EU MDR, FDA, ISO etc. guidelines and quality standards established by the relevant regulatory agencies. Provides input, review, and approval of clinical and medical safety documentation. Operates with independence from business partners in order to provide an independent oversight of quality and compliance in global Clinical Development, Medical Safety including Post Market Surveillance and Medical Affairs. This position supports all Alcon franchises. In this role, a typical day will include: Provides leadership and support in the interpretation and implementation of regulations, standards, and global compliance programs in various GXP settings including computer system and/or software validation and related services for all Alcon franchises. Authors or reviews & approves documentation including but not limited to: Reviewing, commenting and/or approving documents associated with regulatory submissions, notes to file, templates, template revisions, aggregate reports (CEP/CERs, PMCF, PMSP, PSURs), policies, QSPs and SOPs. Provides SME consultation and assists in education and training as well as interpretation of global regulations and guidelines (e.g., EUMDR, FDA, GCP, GLP, GMP, MDR, ISO Standards, GMP, Vigilance, Deviation Management, etc.). Ensures senior management awareness of compliance issues impacting regulatory acceptability, by appropriately escalating as per quality risk management. Provides support to relevant functions on proper identification and escalation of quality related issues. Identifies and collaborates in establishing appropriate measures to assure communication, management and remediation of compliance issues involving Clinical Development/ Clinical Evaluations, Medical Safety and Medical Affairs and other associated departments such as Global Vigilance, Complaint Intake, Regulatory Affairs, Vendor Management, etc. Trends, interprets, and presents compliance data (e.g., deviations or deficiency letters for all franchises) according to worldwide regulatory requirements and specifically EUMDR and Alcon standards. Leads and supports the investigation of deviations and other quality issues detected from any source including NCI & CAPAs. Provides support for audit & inspection preparation, conduct and remediation as needed, for both national and local inspections (e.g., FDA, MEA, MHRA, Notified Body etc.). Provides QA support to Supplier Evaluation Teams as needed and conducts GXP audits as assigned. WHAT YOU'LL BRING TO ALCON: Bachelor’s Degree or Equivalent years of directly related experience (or high school 13 yrs; Assoc. 9 yrs; M.S. 2 yrs; PhD 0 yrs). The ability to fluently read, write, understand, and communicate in English. 5 Years of Relevant Experience Work hours: Exempt Travel Requirements: up to 20% as needed Relocation assistance: No Sponsorship available: No PREFERRED QUALIFICATIONS: Bachelor’s degree in science or technology. QA work experience in a regulated Medical Device / Pharmaceutical Industry. Knowledge of ISO 9001/13485/14971, ISO 14155, Medical Device EU and FDA regulatory requirements (i.e. 21 CFR Part 820). Project Management proficiency and /or Experience with Operational Excellence methodology. Proficient in MS Office. Good data analytics, critical thinking, and decision-making concepts. Good working knowledge of audit functionality. Advocate for exceptional quality and compliance standards – does not compromise on customer expectations and regulatory requirements. HOW YOU CAN THRIVE AT ALCON: Join Alcon’s mission to provide outstanding, innovative products and solutions to improve sight, improve lives, and grow your career! Alcon provides robust benefits package including health, life, retirement, flexible time off, and much more! ATTENTION: Current Alcon Employee/Contingent Worker If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site. Find Jobs for Employees Find Jobs for Contingent Worker Total Rewards Alcon’s Total Rewards programs are designed to align to incentives with business goals, encourage the right values and behaviors, and deliver long-term value. The first layer of our rewards program is compensation. We offer a combination of fixed pay and variable pay, which includes short-term incentives, and long-term incentives for eligible population. Our benefits program provides security for life events through life and disability insurance, supports savings for retirement, promotes good health and well-being and supports associates and their families during times of illness. To learn more about Alcon’s Corporate Social Responsibility including our Total Rewards, click here Pay Range $114,400.00 - $171,600.00 Pay Frequency Annual Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information. At Alcon, we are committed to helping people see better. We believe patients should have access to quality eye care regardless of their economic circumstances; however, barriers to good eye health exist for patients in both developed and emerging markets. Alcon develops and manufactures innovative devices to serve the full life cycle of eye care needs. Its surgical group is one of the largest makers of equipment used for cataract removal and laser vision correction. Its consumer products include the well-known Opti-Free line of contact lens solutions and related products. Alcon, which was founded in 1945, sells its products in 180 countries worldwide. If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site. Find Jobs for Employees Find Jobs for Contingent Worker