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Manager, Regulatory Operations – Medical Devices | Alcon
Alcon is seeking a regulatory operations manager to lead medical device submission teams and compliance initiatives. The role oversees regulatory data, documentation systems, performance metrics, and process optimization.
Сипаттама
- Manage several regulatory operations programs supporting medical device and pharmaceutical portfolios
- Direct teams handling dossier development, Clinical Trial Disclosure, submission coordination and publishing, licensing, and labeling activities
- Make decisions that materially influence project delivery and outcomes
- Use project management, sophisticated problem-solving, communication, leadership, and sector expertise to achieve objectives
- Administer controlled document systems, records retention, and information services
- Follow GxP requirements and standard operating procedures while ensuring documentation accuracy and quality control
- Advance ongoing process enhancement and regulatory adherence
- Manage daily team activities, workload, and productivity
- Design and execute improvements that shorten submission timelines and strengthen documentation quality
- Establish performance indicators such as cycle time, first-pass yield, and renewal timeliness
- Review dashboards, reports, operating metrics, and emerging trends
- Build automated data processes and tracking tools with PowerApps and Power Automate
- Reconcile regulatory and operational data
- Prepare and present updates for executive leaders and senior stakeholders
- Direct cross-functional programs while balancing competing priorities
Талаптар
- Bachelor’s degree or equivalent directly relevant experience; alternatives include a high school diploma with 13 years, an associate degree with 9 years, a master’s degree with 2 years, or a PhD with 1 year of experience
- At least five years of relevant professional experience
- At least three years of proven leadership experience
- Fluent English reading, writing, comprehension, and verbal communication
- Advanced knowledge of the regulatory submission lifecycle for Class I, II, and III medical devices in the United States, European Union, and Canada
- Experience entering and maintaining data and managing registration hierarchies
- Proven project management capability
- Strong communication and stakeholder relationship skills
- Ability to structure, prioritize, and advance several projects at once
- Ability to perform data-quality reviews and validation checks
- Familiarity with FDA eSTAR, Health Canada REP, and European Union Notified Body submission portals
- Employer sponsorship and relocation assistance are unavailable; travel availability of 0–10% is required or expected, as applicable to the role
- 0–10% travel availability
Артықшылықтар
- Dedicated opportunities for professional growth and development
- Health insurance and related benefits
- Life insurance coverage
- Retirement benefits
- Flexible time off for exempt associates
- Paid time off for hourly associates
- Short- and long-term incentive programs for eligible positions
- Health and wellness initiatives
- Programs supporting financial security
- Resources for retirement planning
- Reasonable accommodations for qualified individuals with disabilities
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