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, 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 Senior Regulatory Affairs Specialist within Alcon's 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 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.
• 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 YOU'LL BRING TO ALCON:

• Bachelor's 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 high-quality 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 ISO 13485, 14971, 27001, IEC 62304, 82304, AAMI TIR45, cGMP 21 CFR 820, HIPAA, GDPR, Data integrity

HOW YOU CAN THRIVE AT ALCON:

• Join Alcon's mission to provide top-tier, 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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Alcon's 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 Alcon's Corporate Social Responsibility including our Total Rewards, click here

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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 alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.