Manager II, Regulatory Affairs Strategy for Digital Health

Alcon • Lake Forest, CA

18d • Onsite

About The Position

Manager II, Regulatory Affairs Strategy for Digital Health At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Manager II, Regulatory Affairs Strategy for Digital Health supporting our Quality and Regulatory Affairs team, you will be trusted to interpret regulations as they apply to software products, and other medical device related processes, practices, and procedures as well as investigating and resolving compliance problems, questions, or complaints received from customers, government regulatory agencies, other units of the company, etc. This position is located in our Lake Forest, CA location. IN THIS ROLE, A TYPICAL DAY WILL INCLUDE: 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.

Requirements

• 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

Nice To Haves

• 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

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.

Benefits

• Alcon provides robust benefits package including health, life, retirement, flexible time off for exempt associates, PTO for hourly associates, and much more!

What This Job Offers

• Job Type: Full-time
• Career Level: Manager