This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly. The Manager, Regulatory Operations (Management Path) is primarily responsible for ensuring a controlled documentation system, record retention, and information services in line with regulatory requirements. You will guide and manage others to achieve goals, maintain documentation systems, and coordinate global regulatory submission projects.
In this role, a typical day will include:
- Oversee multiple regulatory operations projects, ensuring goals are met through effective management and oversight in support of medical device and/or pharmaceutical products
- Lead teams responsible for dossier preparation, Clinical Trial Disclosure, submission management, submission publishing, licensing, and labeling, ensuring timely and accurate submission of regulatory documents
- Make key decisions impacting project performance and success
- Apply project management, advanced problem-solving, effective communication, leadership, and industry-specific knowledge
- Adhere to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, and ensuring quality control
- Commit to continuous improvement and compliance with regulatory requirements
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+1 yr)
- The ability to fluently read, write, understand and communicate in English
- 5 Years of Relevant Experience
- 3 Years of Demonstrated Leadership
- Location: Onsite- Fort Worth, TX, Lake Forest, CA
- Schedule: 1st Shift: Monday - Friday
- Travel Requirements: 0-10%
- Sponsorship & Relocation: Not Available
Preferred Qualifications/Skills/Experience:- Manage a team, supervising day-to-day operations to ensure productivity and alignment with departmental objectives for medical devices.
- Demonstrates expertise in the regulatory submission lifecycle and associated processes for Class I, Class II, and Class III medical devices across the United States, European Union, and Canada
- Identify and implement process improvements that reduce submission cycle times, enhance compliance, and improve the quality and consistency of regulatory documentation
- Manage data entry, maintenance and registration hierarchy
- Demonstrated ability to develop and deliver clear, concise, and impactful presentations to executive leadership and senior stakeholders.
- Strong project management skills, with the ability to lead cross-functional initiatives, manage competing priorities, and deliver results within established timelines.
- Excellent communication and stakeholder management skills, including the ability to influence and engage audiences at all organizational levels.
- Proven ability to organize, prioritize, and drive multiple projects simultaneously in a fast-paced environment.
- Apply data quality & validation checks at point of collection
- Define KPIs - cycle time, first-pass yield, on-time renewal
- Monitor and report performance metrics & trends over time
- Monitor dashboards & reports
- Automate data workflows & trackers (PowerApps / Power Automate
- Perform data reconciliation
- Possess comprehensive knowledge of key regulatory submission platforms and portals, including the U.S. Food and Drug Administration (FDA) electronic Submission Template and Resource (eSTAR), Health Canada Regulatory Enrolment Process (REP), and European Union Notified Body submission portals
HOW YOU CAN THRIVE AT ALCON:- Collaborate with teammates to share standard processes and learnings as work evolves!
- See your career like never before with focused growth and development opportunities!
- 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 for exempt associates, PTO for hourly associates, and much more!
Alcon CareersSee your impact at alcon.com.careers
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Compensation and Benefits Alcon's Total Rewards programs are designed to align incentives with business objectives, support our values, and deliver long-term value. Our compensation approach includes a combination of fixed and variable pay, with short-term and long-term incentive opportunities for eligible roles. Our benefits offerings are designed to support associates and their families across key life events, including programs that promote health and well-being, provide financial security, and support retirement planning.
The salary range posted represents the anticipated hiring range for this role. Actual compensation may vary based on factors such as experience, skills, location, and internal equity, and may fall outside the posted range.
Pay Range119,000.00 - 154,000.00
Pay FrequencyAnnual
