Regulatory Affairs Specialist II

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.
Objectives Responsible for providing training, support of filing, and management for RA systems/tools.
Prepare regulatory applications according to health/regulatory authority requirements and guidance.
Responsible for regulatory compliance, regulatory intelligence surveillance and US regulatory licensing, including manufacturing and commercial distribution licensing.
Responsibilities Prepare, assemble, review, and troubleshoot regulatory submissions.
Perform system validation tasks.
Run Reports, Data Entry, verify records and transactions.
Troubleshooting, as required.
Conduct regular reviews of product documentation to identify and address potential compliance issues.
Collaborate with R&D, Quality Assurance, and other relevant departments to integrate regulatory requirements into product development processes.
Serve as the primary liaison between cross-functional team.
Train various colleagues on regulatory processes, such as global processes that may apply to sites or regions.
Ensure final documents are submission-ready in accordance with agency guidance and troubleshoot any advanced document issues.
Write statistical, financial, accounting or auditing reports.
Complete archive requests according to archiving and document retention strategies.
Perform regulatory product and registration data entry.
Troubleshoot and address issues/questions regarding RA processes and data.
Assist in developing best practice in enhancing process efficiency.
Assist with government, regulatory surveys, as needed.
Assist with special projects and audits, as needed.
Requirements Minimum associate degree, bachelor’s degree preferred or equivalent.
Minimum of 1.
5 years Regulatory Affairs experience or relevant experience in a regulated environment.
Excellent communication / interpersonal and writing.
Self-motivated and capable of working independently with minimal supervision.
Skilled in basic technologies (e.
g.
, MS Office Applications, Adobe Acrobat, MS Project), especially proficiency in MS Excel.
Some knowledge of country regulations (med device and pharma), post market surveillance, ISO and IEC.
Detail oriented with the ability to proofread and check documents for accuracy and inconsistencies.
Command of English language (verbal and written) Ability to work and contribute to a team environment.
Ability to understand scientific information and start to assess whether technical arguments are articulated clearly.
Knowledge of good documentation practices Act as primary contact with regulatory authorities with supervision Operates with a sense of urgency, Agility & flexibility.
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 As required by Colorado’s Salary Transparency Law, Bausch + Lomb provides a good faith minimum and maximum salary range of compensation for roles that can or will be performed, in Colorado.
Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location.
For Colorado, the range of starting annual base pay for this role is $65,000 to $95,000.
As required by New York City’s salary transparency provisions of the New York City Human Rights Law, Bausch + Lomb provides a good faith minimum and maximum salary range of compensation for roles that can or will be performed, in New York City.
Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location.
For New York City, the range of starting annual base pay for this role is $65,000 to $95,000.
As required by California's Salary Transparency Law, Bausch + Lomb provides a good faith minimum and maximum salary range of compensation for roles that can or will be performed, in California.
Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location.
For California, the range of starting annual base pay for this role is $65,000 to $95,000.
As required by Washington's Salary Transparency Law, Bausch + Lomb provides a good faith minimum and maximum salary range of compensation for roles that can or will be performed, in Washington.
Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location.
For Washington, the range of starting annual base pay for this role is $65,000 to $95,000.
As required by New York State's pay transparency bill, Bausch + Lomb provides a good faith minimum and maximum salary range of compensation for roles that can or will be performed, in New York State.
Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location.
For New York State, the range of starting annual base pay for this role is $65,000 to $95,000.
As required by Hawaii's pay transparency bill, Bausch + Lomb provides a good faith minimum and maximum salary range of compensation for roles that can or will be performed, in Hawaii.
Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location.
For Hawaii, the range of starting annual base pay for this role is $65,000 to $95,000.
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.
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.