Senior Regulatory Affairs Specialist

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 Regulatory Affairs support to gain or maintain regulatory authorizations to market medical devices in the US. This position requires the incumbent to prepare submissions, review and approve product labeling & advertising, support facility inspections and participate in other regulatory support activities as required.

Responsibilities:

• With the oversight of Regulatory leadership, develops regulatory strategies and timelines for product development and product improvement projects.
• Generates submissions (i.e. PMA, 51O(k), PMA supplements) to obtain various approvals to commercially distribute products. This requires participation in product development teams, as well as responsibility to review, analyze, and comment on technical reports. This also may require interaction with government officials on product submissions and approvals.

• Produce subsequent submissions (annual reports, change notifications, etc.) to facilitate the maintenance of product approvals. Review and approve labeling and advertising of B+L device products.

• Review and provide input on departmental policies and procedures.
• Provide input and comment to regulations standards which may affect B+L products.
• Other job responsibilities as needed.

Qualifications:

• BA/BS degree in a technical or scientific discipline. Additional professional training a plus.
• Must possess at least an advanced level of performance in the majority of the following core competencies: influence key stake holders, business acumen, project management, relationship building, regulatory expertise.

• 3-5 years in a Regulatory environment with demonstrated success.

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 salary for this role is $65,000 to $115,000.

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.

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.