Sr Manager, Regulatory Operations - Publishing & Registration Management (Devices)

Alcon; Texas; Ibrido; USD 152.000 - 197.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

Retirement plan

Paid time off

Descrizione del lavoro

Alcon is seeking a Sr. Manager, Regulatory Operations to direct product and process submissions, ensuring timely approvals and robust regulatory support globally.

You will lead cross-functional teams in dossier preparation, submission publishing, licensing, and labeling for medical devices and/or pharmaceuticals. The role emphasizes strategic oversight, leadership, and deep GxP knowledge, with a track record of optimizing submission timelines and improving regulatory processes.

Competenze

• Bachelor’s Degree or Equivalent years of directly related experience (or high school +15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs)
• Fluent in English (read, write, understand)
• 7+ years of relevant regulatory experience
• 5+ years of demonstrated leadership

Mansioni

• Oversee multiple regulatory operations projects ensuring goals are met for medical devices and/or pharmaceutical products
• Lead teams responsible for dossier preparation, Clinical Trial Disclosure, submission management, licensing, and labeling
• Make key decisions impacting project performance and outcomes
• Apply project management, problem-solving, communication, leadership and regulatory knowledge
• Adhere to GxP and SOPs, maintain documentation and quality control
• Commit to continuous improvement and regulatory compliance

Conoscenze

Regulatory submissions

GxP compliance

Global regulatory

FDA eSTAR

Health Canada REP

CE/Notified Body

CDRH CECATS

CFG/COE/FSC

Process improvement

Formazione

Bachelor’s Degree or equivalent

Descrizione del lavoro

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us? 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 Sr. Manager, Regulatory Operations (Management Path) is primarily responsible for directing product/process submissions, ensuring timely approvals, and maintaining high-quality regulatory support. You will lead negotiations to align on optimized regulatory strategies and manage global strategies to enhance product value.

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 +15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs)
• The ability to fluently read, write, understand and communicate in English
• 7 Years of Relevant Experience
• 5 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:

• Demonstrate deep 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
• 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.
• Experienced in managing export certification activities through the Center for Devices and Radiological Health (CDRH) Export Certification Application and Tracking System (CECATS), including Certificates to Foreign Government (CFG), Certificates of Exportability (COE), and European Union Free Sale Certificates (FSC).
• Lead the optimization and standardization of apostille, notarization, legalization, and country-specific documentation processes to support international regulatory submissions, accelerate approval timelines, and improve operational efficiency.
• Serve as a subject matter expert on global registration and submission pathways, providing strategic guidance for regulatory submissions and market access activities across the U.S., EU, Canada, and international markets.
• Identify and implement process improvements that reduce submission cycle times, enhance compliance, and improve the quality and consistency of regulatory documentation.

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!

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 of experience, skills, location, and internal equity, and may fall outside the posted range. Pay Range 152,150.00 - 196,900.00 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 [e-mail] 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.