Sr. Director, Regulatory Affairs, Instrumentation at Alcon

Fort Worth, Texas, United States

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Healthcare, OphthalmologyIndustries

Requirements

Lead strategic planning, cross-functional collaboration, advanced problem-solving, and strong communication skills to impact multiple departments and overall business outcomes
Ensure all associates adhere to Good Practice (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
Meet individual job requirements and contribute to the overall compliance of the organization
Compliance with regulatory requirements

Responsibilities

Strategically lead Regulatory Affairs team, ensuring compliance with regulatory requirements
Direct the development and submission of product/process registrations, progress reports, supplements, amendments, and periodic experience reports
Provide strategic product direction to teams, interact and negotiate evidence requirements with regulatory agencies, ensure rapid and timely approval of products and maintain approval throughout the product lifecycle
Advise development and commercial teams on new product development, safety, efficacy, manufacturing changes, product line extensions, labeling, and appropriate regulations and interpretations
Oversee the execution and coordination of various regulatory affairs activities, including product submissions, renewals, and updates to ensure timely submission and approvals
Oversee creative and innovative approaches to competitive claims development and labeling, advertising and promotional material review and approval for product portfolios, ensuring ethical conduct and compliance with applicable national and international laws, codes, and regulations
Proactively monitor and evaluate the US and OUS regulatory promotional environment by reviewing guidelines, enforcement letters, advisories from key international bodies and attending major industry meetings. Use this intelligence to inform promotional claim strategies
Provide US and Global Regulatory promotional perspective to business functions to ensure commercially viable labeling supporting business strategies
Provide regulatory strategies for new product introductions and product changes, maintaining regulatory compliance to drive competitive advantage
Support products in either the medical device and/or pharmaceutical/OTC family of products, ensuring adherence to all relevant regulations
Oversee regulatory assessment and acquisition/integration strategy for all merger and acquisition (M&A) activities

Skills

Regulatory Affairs

Product Registrations

Regulatory Strategy

Compliance Management

Regulatory Submissions

Agency Negotiations

Product Lifecycle Management

Quality Assurance

Global Regulations

Labeling Regulations

Manufacturing Changes

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