Bausch + Lomb Manager, Regulatory Affairs in Rochester, New York
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.
The Regulatory Affairs Manager handles all regulatory development aspects of contact lenses and solutions. The manager participates on product development teams to provide regulatory guidance for devices assigned, manage relevant regulatory strategy components, interacts with Regulatory Authorities for their assigned products and interacts with other departments to provide regulatory support.
Responsibilities may include but are not limited to:
Responsible for developing a product regulatory strategy for assigned devices.
Liaise with regulatory counterparts to ensure regional requirements are incorporated into product strategy development.
Develop a product regulatory timeline aligned to the company’s product development, with key regulatory milestone, and activities for agency filing.
Coordinate with the team on the development of product labels.
Ensure labeling content and product documentation is developed in accordance with regulatory requirements.
Participate as a member of the product development team(s) to build awareness of Regulatory Authority requirements and timing for submissions.
Coordinate with key partners and regional counterparts to ensure timely and accurate submissions to Regulatory Authorities.
Act as a regulatory contact for assigned devices.
Manage interactions with other departments (e.g., Quality, Compliance) during Regulatory Authority inspections.
Provide regulatory guidance/input to device change control and internal product review boards.
Manage assigned personnel.
Other job responsibilities as needed.
Knowledge of device regulatory affairs discipline throughout the product lifecycle, including Design, Development, Promotion and Advertising, Labeling, Change Control, Commercialization, and Operations.
Knowledge of US laws, regulations, and guidance that affect assigned devices.
Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses.
Ability to interpret FDA policies and guidance and correctly apply them as appropriate in product development and labeling regulatory activities for assigned devices.
Ability to influence and partner with cross-functional teams.
Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory approval.
Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported by data.
Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks.
Demonstrated ability in analytical reasoning and critical thinking skills.
Strong capability to contribute and lead a team environment.
Strong business acumen and ability to see the business drivers outside of Regulatory Affairs.
Excellent communication skills; both oral and written.
Strong interpersonal skills with the ability to influence others in a positive and effective manner.
Demonstrated ability to contribute to a continuous learning and process improvement environment.
Capacity to react quickly and decisively in unexpected situations.
Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies.
Focused ability to influence operational excellence and performance metrics.
Risk adverse where needed with the ability to identify potential solutions to complex problems.
8+ years relevant medical device industry and regulatory experience.
Ophthalmic device regulatory experience highly preferred.
Bachelor’s degree in science or health related field.
Advanced degree preferred (PhD, MD, MS, PharmD, or equivalent).
Minimum two years’ experience building and managing a team.
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 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 pay for this role is $90,000 to $130,000.
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.
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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