Senior Regulatory Affairs Specialist, Digital Health / Software Products at Alcon
Lake Forest, California, USA -
Full Time


Start Date

Immediate

Expiry Date

19 Jul, 25

Salary

0.0

Posted On

20 Apr, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Reporting Requirements, Interoperability, Regulatory Agencies, Regulations, Development Models, Regulatory Affairs, Project Documentation, Cfr, Iec, Project Teams, Software, Hipaa, Research, Regulatory Requirements, Iso, Documentation, Adherence

Industry

Pharmaceuticals

Description

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.
Responsibilities
  • 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
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