Manager, Regulatory Affairs

Date: Sep 23, 2022

Location: US-NY-Rochester, New York, US

Company: Bausch & Lomb

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. 

 

 

Position summary:

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.

 

Key responsibilities:

  • 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

 

Qualifications/experience:

  • Bachelor’s degree in science or health related field
  • Advanced degree preferred (PhD, MD, MS, PharmD, or equivalent)
  • 8+ years relevant medical device industry and regulatory experience
  • Ophthalmic device regulatory experience highly preferred
  • 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

 

  

 

This position may be available in the following location(s): US - Remote

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.

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