Manager II, Regulatory Affairs Strategy for Digital Health

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 youll 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.

WHAT YOULL BRING TO ALCON :

PREFERRED SKILLS AND EXPERIENCE :

HOW YOU CAN THRIVE AT ALCON :

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Alcons 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 Alcons Corporate Social Responsibility including our Total Rewards click here

Pay Range

$100000.00 - $150000.00

Pay Frequency

Annual

Alcon 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 and let us know the nature of your request and your contact information.

Required Experience :

Manager

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 100000 - 150000