Alcon · 2 months ago
Manager II, Regulatory Affairs Strategy for Digital Health
Lake Forest, California
Full-time
Onsite
Mid, Senior Level
$98K/yr - $162K/yr
5+ years expAlcon is a global leader in eye care, dedicated to helping people see brilliantly. The Manager II, Regulatory Affairs Strategy for Digital Health will oversee regulatory compliance for software products, develop regulatory strategies, and support cross-functional teams in navigating regulatory requirements.
Health CareManufacturingMedical Device
Responsibilities
Oversee the preparation and submission of regulatory documents, ensuring compliance with relevant regulations. Develops documents that are clear, concise, and complete to facilitate reviews/approvals
Acts as the voice of Regulatory Affairs on project teams, by developing the project regulatory strategy with minimal guidance. Provide strategic regulatory guidance to cross-functional teams
Implements policies and procedures to ensure compliance with the appropriate statutes and regulations and to ensure that regulatory reporting requirements are met
Participates in resolution of key regulatory issues, by acting as interface between project team and the larger regulatory organization to ensure needed support and inputs are gathered
Provides regulatory input throughout software development activities (including postproduction software changes) in both Agile and waterfall software development models
Supports internal/external audits as a Regulatory Subject Matter Expert for software products
Audit or evaluate current policies, procedures, and documentation for compliance with government laws and regulations
Works in close collaboration with internal stakeholders and supports multiple projects. Lead and develop a team, working with various departments to influence regulatory outcomes
Provides support as needed for non-project related 'regulatory excellence' activities
Ensures compliance with global regulatory requirements as they pertain to software products, and adherence to internal policies and processes
Responds to regulatory requests from across the organization in a timely manner
Provides high quality regulatory support for assigned products/projects
Partners with internal stakeholders (e.g. regions) to align on an optimized regulatory strategy in order to achieve business objectives
May provide regulatory review and approval of project documentation and promotional materials
May provide input to marketing and/or research and development on new product opportunities as a result of changes in the regulatory environment
May develop and direct compliance training and monitoring programs
Manage multiple projects, develop and implement regulatory strategies, and ensure alignment with business objectives
Make key decisions within projects, requiring leadership, strategic planning, advanced problem-solving, and strong communication skills
Adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training
Contribute to the overall compliance of the organization and commit to continuous improvement in operations
All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, 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
Qualification
Required
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
Preferred
Understanding of Software-as-a-Medical-Device (SaMD), Artificial Intelligence (AI) and Machine Learning (ML), cybersecurity, interoperability, and other Digital Health concepts
Knowledge of compliance requirements with ISO 13485, 14971, 27001, IEC 62304, 82304, AAMI TIR45, EU MDR, cGMP 21 CFR 820, HIPAA, GDPR, Data integrity
Experience with Digital Health and software application development
Benefits
Health
Life
Retirement
Flexible time off for exempt associates
PTO for hourly associates
Company
Alcon
Alcon specializes in developing and manufacturing innovative medicines and devices to serve the cycle of eye care.
10001+ employees
H1B Sponsorship
Alcon has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (27)
2024 (35)
2023 (12)
2022 (15)
2021 (45)
2020 (20)
Funding
Current Stage
Public CompanyTotal Funding
unknown2010-12-15Acquired
2002-03-21IPO
Leadership Team
David Endicott
Chief Executive Officer
Tim Stonesifer
Chief Financial Officer
Recent News
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