Senior Regulatory Affairs Specialist Digital Health Software Products

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 Senior Regulatory Affairs Specialist within Alcons Digital Health Quality and Regulatory Affairs (QRA) team you will be trusted to ensure compliance with regulatory requirements for software products financial processes and other operational practices and procedures. This includes interpreting relevant regulations investigating compliance issues and resolving questions or complaints from various stakeholders including internal company units customers and government regulatory agencies. In this role a typical day will include:

• Implements policies and procedures to ensure compliance with the appropriate statutes and regulations and to ensure that regulatory reporting requirements are met.
• Acts as the voice of Regulatory Affairs on project teams by developing the project regulatory strategy with minimal guidance.
• 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 post production software changes) in both Agile and waterfall software development models.
• Supports internal/external audits as a Regulatory Subject Matter Expert for software products.
• Audits or evaluates current policies procedures and documentation for compliance with government laws and regulations.
• Provides support as needed for nonproject related regulatory excellence activities.
• Ensures compliance with global regulatory requirements as they pertain to software products and adherence to internal policies and processes.
• Partners with internal stakeholders (e.g. regions) to align on an optimized regulatory strategy in order to achieve business objectives.
• May develop and implement programs designed to increase employee awareness and knowledge of compliance policies.
• 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.

WHAT YOULL BRING TO ALCON:

• Bachelors Degree or Equivalent years of directly related experience (or high school 10 yrs; Assoc.6 yrs; M.S.0 yrs)
• The ability to fluently read write understand and communicate in English
• 2 Years of Relevant Experience
• Quality and regulatory experience within the life sciences device sector
• Experience with medical device and software device validation
• Experience with regulatory submissions including demonstrating strong technical scientific writing skills in the form of highquality regulatory submission documents
• Demonstrated ability to coordinate and work effectively with multiple stakeholders.
• Demonstrated organizational and time management skills including the ability to plan and implement multiple projects adhere to timelines and communicate project status and issues.
• Ability to support the business by communicating effectively managing issues proactively resolving conflicts and mitigating risks.
• Ability to work in a matrixed environment and influence internal partners to achieve desired business outcomes.
• Drives superior results by taking initiative planning and implementing projects setting priorities and holding self and others accountable to meet commitments.

Preferred Qualifications:

• Experience with Digital Health and software application development
• Deep understanding of Software as a Medical Device (SaMD) Artificial Intelligence/Machine Learning (AI/ML) cybersecurity interoperability and other Digital Health concepts
• Knowledge of compliance requirements with ISOIECAAMI TIR45 cGMP 21 CFR 820 HIPAA GDPR Data integrity

HOW YOU CAN THRIVE AT ALCON:

• Join Alcons mission to provide toptier innovative products and solutions to enhance sight & enhance lives.
• Grow your career in a highly collaborative and diverse environment.
• Alcon provides robust benefits package including health life retirement flexible time off and much more!

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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 longterm value. The first layer of our rewards program is compensation. We offer a combination of fixed pay and variable pay which includes shortterm incentives and longterm 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 wellbeing and supports associates and their families during times of illness. To learn more about Alcons Corporate Social Responsibility including our Total Rewards click here

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