Manager I, Regulatory Affairs Strategy

alcon; Fort Worth (TX); On-site; USD 119,000 - 154,000; Full time

Benefits offered by this job

Robust benefits package

Growth and development opportunities

Flexible time off

Job summary

Alcon is seeking a Manager I for Regulatory Affairs Strategy to support compliance for its Intraocular Device portfolio. This full-time position in Fort Worth, Texas, entails coordinating product submissions and ensuring regulatory adherence across global markets.

The ideal candidate will possess a Bachelor's degree and 5 years of relevant experience, along with strong collaboration and communication skills. Alcon offers a competitive benefits package as part of its commitment to employee growth and development.

Qualifications

• 5 Years of Relevant Experience required.
• Ability to fluently read, write, understand and communicate in English.

Responsibilities

• Coordinate product submissions and renewals.
• Manage post-approval commitments and lifecycle.
• Support regulatory strategy execution.
• Adhere to Good Practice (GDPs) regulations.

Skills

Regulatory strategy

Collaboration

Effective communication

Problem-solving

Quality control

Education

Bachelor's Degree or Equivalent

Job description

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?

Alcon is looking to hire a Manager I, Regulatory Affairs Strategy. You will support regulatory compliance and strategy activities for Alcon's Intraocular Device portfolio, including intraocular lenses (IOLs), implantable glaucoma devices and associated delivery systems. This onsite position is based in Fort Worth, Texas (other on-site locations available) and plays a key role in enabling compliant, timely access to innovative devices across global markets.

In this role, you will develop strong scientific and technical product knowledge and serve as a key resource to country Regulatory Affairs associates by providing regulatory guidance and information. You will support regulatory strategy execution partnering crossfunctionally to ensure alignment with evolving regulatory expectations. Through your work, you will help strengthen regulatory excellence, support business objectives, and uphold Alcon's commitment to quality, compliance, and patient safety.

This role is on-site at any Alcon locations and a typical day would include:

• Perform specialized tasks and conduct independent research within the Regulatory Affairs Strategy team to optimize outcomes and contribute to project goals.
• Coordinate product submissions, renewals, and updates by liaising with plants, agents, and authorities to ensure timely submissions and approvals.
• Ensure rapid and timely approval of products and their continued approval.
• Manage post-approval commitments and lifecycle management.
• Provide regulatory strategies for new product introductions and changes, maintaining compliance to drive competitive advantage.
• Support products in the medical device family, ensuring adherence to relevant regulations.
• Adhere to Good Practice (GDPs) regulations by following Standard Operating Procedures (SOPs), maintaining documentation, ensuring quality control, and completing required training.
• Support the collection and analysis of regulations/standards to ensure product compliance, and engage in activities of industry associations like the Advanced Medical Technology Association as needed (Advamed).
• Commit to continuous improvement in operations and contribute to the organization’s overall compliance.
• All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, and completing all required training. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.

Key Success Factors

• Ability to translate technical and clinical data into regulatory strategy
• Strong collaboration and influence skills within a matrixed organization
• Effective communication and regulatory writing skills
• Ability to manage multiple priorities and timelines
• Proactive approach to problem-solving and risk mitigation
• Commitment to quality, compliance, and patient safety

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

How You Can Thrive at Alcon

• 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 a robust benefits package including health, life, retirement, flexible time off and much more.
• Travel up to 10%

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 wellbeing, provide financial security, and support retirement planning.

Pay Range

119,000.00 - 154,000.00

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.