Manager II, Regulatory Affairs Strategy for Digital Health at Alcon

Lake Forest, California, United States

Apply Now

Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, Eye Care, Digital HealthIndustries

Requirements

Interpret regulations as they apply to software products and other medical device related processes, practices, and procedures
Investigate and resolve compliance problems, questions, or complaints from customers, government regulatory agencies, or other company units
Lead and develop a team, working with various departments to influence regulatory outcomes
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
Commit to continuous improvement in operations and contribute to overall organizational compliance

Responsibilities

Oversee the preparation and submission of regulatory documents, ensuring compliance with relevant regulations, and develop clear, concise, and complete documents to facilitate reviews/approvals
Act 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
Implement policies and procedures to ensure compliance with statutes, regulations, and regulatory reporting requirements
Participate in resolution of key regulatory issues, acting as interface between project teams and the larger regulatory organization
Provide regulatory input throughout software development activities (including postproduction changes) in Agile and waterfall models
Support 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
Work in close collaboration with internal stakeholders and support multiple projects
Ensure compliance with global regulatory requirements for software products and adherence to internal policies and processes
Respond to regulatory requests from across the organization in a timely manner
Provide high quality regulatory support for assigned products/projects
Partner with internal stakeholders (e.g., regions) to align on optimized regulatory strategies to achieve business objectives
Provide regulatory review and approval of project documentation and promotional materials
Provide input to marketing and/or R&D on new product opportunities due to regulatory environment changes
Develop and direct compliance training and monitoring programs
Manage multiple projects, develop and implement regulatory strategies, and ensure alignment with business objectives
Provide support for non-project related "regulatory excellence" activities

Skills

Regulatory Affairs

Digital Health

Software Regulations

Medical Device Regulations

Regulatory Strategy

Compliance

Agile Development

Waterfall Development

Regulatory Submissions

Cross-Functional Teams

Alcon

Specializes in eye care products and solutions

About Alcon

Alcon specializes in eye care products and vision solutions aimed at improving people's quality of life through better vision. Their product offerings include solutions for cataract surgery, retinal health, and contact lenses. Alcon's products work by utilizing advanced technology and research to provide effective treatments and aids for various eye conditions. What sets Alcon apart from its competitors is its strong emphasis on research and development, ensuring that they remain leaders in the eye care industry. The company's goal is to enhance vision and overall quality of life for individuals while promoting a diverse and inclusive workplace.

Geneva, SwitzerlandHeadquarters

1945Year Founded

IPOCompany Stage

Social Impact, HealthcareIndustries

10,001+Employees

Benefits

Medical, dental, & vision coverage

HSA Medical Plan

PTO

Paid Parental leave

401k

Retirement Plan Company Contribution

Low payroll deductions

Tuition Reimbursement Program

Annual Bonus

Free Family Contact Lens Program

12 Company Paid Holidays

Risks

FDA recall of contact lenses may harm Alcon's reputation and financial standing.

Antitrust case denial could lead to legal challenges and financial penalties.

Innovative competitors like Signal12 threaten Alcon's market share in eye care.

Differentiation

Alcon leads in eye care with a broad product portfolio and global reach.

The company invests heavily in R&D, ensuring cutting-edge vision solutions.

Alcon's commitment to diversity and inclusion strengthens its corporate culture.

Upsides

Acquisition of BELKIN Vision enhances Alcon's glaucoma treatment options with DSLT technology.

Orbis Flying Eye Hospital project boosts Alcon's global presence and eye care standards.

Recognition as a top employer in Singapore attracts and retains top talent.

Land your dream remote job 3x faster with AI

Try Jobo Free