Manager, Regulatory Operations – Regulatory Data Management, Devices

Alcon

. Oversee multiple regulatory operations projects supporting medical device and pharmaceutical products .

Posted 10/3/2026full-timeUnited StatesMid-LevelSenior💰 $119,000 - $154,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory operations for medical devices and pharmaceuticals, with a strong focus on project management, compliance with GxP regulations, and effective communication with stakeholders. Proven ability to lead teams, drive process improvements, and manage the regulatory submission lifecycle across multiple regions.

Highest-signal resume keywords

Regulatory Submission Lifecycle ExpertiseProject Management SkillsLeadership ExperienceGxP Compliance KnowledgeData Workflow Automation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Dossier PreparationClinical Trial DisclosureSubmission ManagementQuality ControlData ReconciliationProcess ImprovementKPI DefinitionDocumentation Systems MaintenanceData Quality ChecksRegulatory Submission Platforms

Soft Skills

Communication SkillsStakeholder ManagementProblem-SolvingOrganizational SkillsTeam Leadership

Tools & Technologies

PowerAppsPower AutomateFDA eSTARHealth Canada REPEU Notified Body Submission Portals

Industry Keywords

Medical DevicePharmaceuticalRegulatory ComplianceControlled DocumentationSubmission PublishingLicensingLabelingContinuous ImprovementPerformance MetricsSubmission Cycle Time

About the role

Key responsibilities & impact

Oversee multiple regulatory operations projects supporting medical device and pharmaceutical products
Lead teams responsible for dossier preparation, Clinical Trial Disclosure, submission management, submission publishing, licensing, and labeling
Make key decisions impacting project performance and success
Apply project management, advanced problem-solving, communication, leadership, and industry knowledge
Maintain controlled documentation systems, record retention, and information services
Adhere to GxP regulations and SOPs while maintaining accurate documentation and quality control
Drive continuous improvement and regulatory compliance
Supervise day-to-day team operations and productivity
Identify and implement process improvements to reduce submission cycle times and improve documentation quality
Define KPIs including cycle time, first-pass yield, and on-time renewal
Monitor dashboards, reports, performance metrics, and trends
Automate data workflows and trackers using PowerApps and Power Automate
Perform data reconciliation
Develop and deliver presentations to executive leadership and senior stakeholders
Lead cross-functional initiatives and manage competing priorities

Requirements

What you’ll need

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)
5 Years of Relevant Experience
3 Years of Demonstrated Leadership
Fluently read, write, understand and communicate in English
Expertise in the regulatory submission lifecycle for Class I, Class II, and Class III medical devices across the United States, European Union, and Canada
Experience with data entry, maintenance and registration hierarchy
Strong project management skills
Excellent communication and stakeholder management skills
Ability to organize, prioritize, and drive multiple projects simultaneously
Ability to apply data quality and validation checks
Knowledge of regulatory submission platforms including FDA eSTAR, Health Canada REP, and European Union Notified Body submission portals
Sponsorship & relocation not available
0–10% travel availability

Benefits

Comp & perks

Focused growth and development opportunities
Health benefits
Life insurance
Retirement benefits
Flexible time off for exempt associates
PTO for hourly associates
Short-term and long-term incentive opportunities for eligible roles
Programs promoting health and well-being
Financial security programs
Retirement planning support
Reasonable accommodation for individuals with disabilities