Sr. Manager, GRA Labeling 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, Eye Care, HealthcareIndustries

Requirements

Bachelor’s Degree or Equivalent years of directly related experience (or high school +15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs)
The ability to fluently read, write, understand and communicate in English
7 Years of Relevant Experience
5 Years of Demonstrated Leadership
Worksite location: Onsite (Houston or Fort Worth, TX; Irvine or Lake Forest, CA; Sinking Springs, PA)
Travel: 0-5%
No relocation or sponsorship assistance

Responsibilities

Develop and implement labeling strategies to ensure compliance with global medical device regulations and standards, including FDA, CE Marking, Health Canada and ISO
Oversee the management, review, and approval of Medical Device Labeling Content and artwork for various products, ensuring regulatory and internal compliance
Support regulatory objectives such as Post-Production Risk Reviews (PPRR), Risk Management Report (RMR), Clinical Evaluation Report (CER), labeling gap assessments, and labeling technical documentation
Manage and implement harmonization activities to ensure consistent labeling across different markets and handle variations in response to unique local/regional requirements and regulatory changes
Lead efforts to integrate advanced technologies and automation solutions to enhance labeling processes and operational efficiency
Drive continuous improvement initiatives to optimize labeling processes, increase efficiency, and ensure regulatory compliance
Provide expertise in regulatory standards, mentor team members, and stay current with industry trends and regulatory changes
Support products in the medical device and/or pharmaceutical families, ensuring adherence to all relevant regulations
Make decisions impacting project performance and success, requiring project management, advanced problem-solving, effective communication, and industry-specific knowledge
Adhere to GxP regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, ensuring quality control, and completing required training
Meet individual job requirements and contribute to the overall compliance of the organization

Skills

Regulatory Labeling

FDA Regulations

CE Marking

Health Canada Regulations

ISO Standards

Labeling Compliance

Artwork Approval

Risk Management

Clinical Evaluation Report

Regulatory Harmonization

Medical Device Regulations

Global Regulatory Affairs

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