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 nearly 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 12,500 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:

　　The Senior Specialist, Regulatory Affairs is responsible for compliance and regulatory initiatives supporting our surgical medical device portfolio. This position is responsible for the critical product approvals and post-marketing activities in the US, Canada and Europe and will assist with global market registrations.

　　Responsiblities:

　　Responsible for participating in the regulatory lifecycle responsibilities for the surgical medical device portfolio.

　　Reviews labeling and labeling requirements for surgical medical device portfolio.

　　Align with global regulatory counterparts to ensure regional requirements are considered in product development.

　　Ensure that regulatory timelines are aligned to device development and execute as planned.

　　Maintain regulatory data and licenses.

　　Interacts with the FDA, Notified Bodies, and Health Authorities.

　　Participates in cross-functional teams.

　　Ensure compliance with regulatory requirements as well as supporting Quality System requirements such as change control, distribution, suppliers, CAPA, complaints & recalls, labeling and promotional materials.

　　Requirements:

　　Bachelors degree in engineering, life sciences or equivalent technical field; advanced degree preferred

　　5+ years experience in the regulatory field or regulated industry with FDA and applicable international regulations and standards

　　Experience with medical devices

　　Preferred Qualifications:

　　Experience with Ophthalmology experience a plus.

　　Proficient with planning and preparing complex regulatory submissions for global filings to include, but not limited to, the US (i.e., PMA, IDE, 510(k)) Europe (MDR and UKCA) and Canada.

　　Demonstrated ability in analytical reasoning and critical thinking skills.

　　Excellent communication skills both oral and written.

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

　　Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in device development and regulatory activities.

　　Excellent planning and organizational skills. Ability to manage multiple priorities and ability to demonstrate good regulatory judgment.

　　Excellent team player with experience in cross-functional teams.

　　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

　　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.

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