Manager II, Regulatory Affairs Strategy

Kampala, Central Region
Permanent
Full-time

1 day ago

About the jobAt Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates worldwide, we innovate fearlessly, champion progress, and act with speed to advance global eye health. At Alcon, you'll be recognized for your contributions, supported by an inclusive culture, and empowered to grow your career like never before. Together, we go above and beyond to make a meaningful 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 critical organization responsible for ensuring our products comply with global, local, and internal regulatory requirements while meeting the highest standards of quality. As a Manager II, Regulatory Affairs Strategy, you will support regulatory compliance activities for Alcon's Surgical portfolio, including consumable and accessory medical devices. This onsite position is based in Houston, Texas (other on-site locations available) and plays an important role in enabling compliant and timely product access across the global marketplace.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 with a focus on medical device consumables and accessories within the Surgical franchise, partnering cross-functionally 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.In this role, a typical day will 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
Oversee promotional material approval, ensuring ethical conduct and compliance with laws, codes, and regulations
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 (GxP) 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 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 Requirements/Minimum Qualifications:

Bachelor's Degree or Equivalent years of directly related experience (or high school +20 yrs.; Assoc.+16 yrs.; M.S.+9 yrs.; PhD+8 yrs.)
The ability to fluently read, write, understand, and communicate in English
Relocation Assistance: Not Available
Sponsorship Available: Not Available

Preferred requirements:

2 Years of Relevant Experience

How to Thrive at Alcon:

Manage your own workload and schedule while hitting your set targets.
Build positive working relationships to achieve positive goals and business objectives.
Alcon provides robust benefits package including health, life, retirement, flexible time off for exempt associates, and much more!

Alcon Careers See your impact at alcon.com/careersATTENTION: 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.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, Pay Range $105,000.00 - $175,000.00Pay Frequency AnnualAlcon 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.

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