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Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing, and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

Objective

The LRS Specialist is responsible for the development and maintenance of Labeling Requirements Specification (LRS) templates and product specific content documents. Accountable to ensure product labels are accurate, compliant and maintained globally.

Key Activities/Responsibilities

• Accountable for the creation and maintenance of labeling requirements specification (LRS) templates and product specific documents for global products to ensure compliance with relevant FDA, MDR, ISO and other global regulations.

• Ensures product labels are accurate, compliant and maintained globally.

• Conducts standards assessments when new standards/regulations or changes to existing standards/regulations are published. Responsible for assessing impact to current product labeling and executing change requests to facilitate labeling updates to meet regulations.

• Leads meetings and discussions with cross-functional teams (Regulatory Affairs, Medical Affairs, Engineering, Quality, Legal, Commercial, Site Labeling/Graphic Leads) to prepare, populate and drive alignment of labeling specific content to meet requirements in the LRS.

• Leads and tracks to resolution any issues encountered during LRS development and approval.

• Attends RA meetings and external standards meetings with Quality and cross- functional teams for labeling requirement visibility.

• Monitors, evaluates and recommends improvements to labeling process, systems, tools and/or procedures.

• Participates in global labeling projects, ensuring accuracy of all labeling components as well as timeliness of projects to meet all commitments and deadlines.

• Other duties as assigned.

Requirements

TECHNICAL COMPETENCIES:

Knowledge of medical device regulatory affairs discipline throughout the product lifecycle including Development, Commercialization, and Operations.

Knowledge of EU Medical Device and FDA regulations relating to submissions and regulatory approval of medical devices.

Knowledge of medical device product labeling processes for review and obtaining regulatory approvals.

Strong technology skills and abilities, especially with Microsoft Office programs and web-based programs.

Ability to critically and efficiently review detailed information to support a labeling revision.

PROFESSIONAL COMPETENCIES:

Demonstrated ability in analytical reasoning and critical thinking skills Ability to both contribute and lead in a team environment

Strong communication skills; both oral and written

Strong interpersonal skills with the ability to influence others in a positive and effective manner

Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies – able to do so quickly without sacrificing attention to detail

Experience

5+ years relevant medical device and regulatory experience. Bachelor’s degree or higher. Applied knowledge of European (MDD and MDR) and US FDA labeling requirements.

We offer competitive salary & excellent benefits including:

• Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date

• 401K Plan with company match and ongoing company contribution

• Paid time off – vacation (3 weeks - prorated upon hire), floating holidays and sick time

• Employee Stock Purchase Plan with company match

• Employee Incentive Bonus

• Tuition Reimbursement (select degrees)

• Ongoing performance feedback and annual compensation review

This position may be available in the following location(s): [[location_obj]]

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

To learn more please read Bausch+Lomb's Job Offer Fraud Statement (https://hcm2preview.sapsf.eu/bauschhealT4/Bausch_job_posting_statement.docx) .

Our Benefit Programs: https://www.bausch.com/careers/benefits/

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.