Manager, Regulatory Affairs

Date: Sep 15, 2022

Location: US-FL-Clearwater, Florida, 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 details:

The Regulatory Affairs Manager will join a world-class Global Regulatory Affairs Organization.   This position is part of cross-functional teams that improve lives globally by providing products that help people see better.   You will also have opportunities for professional growth at an organization that develops cutting edge ophthalmic medical devices.  

 

Duties & Responsibilities

  • Plan, coordinate & prepare all regulatory documents in support of new product registrations, including US PMAs and EU MDR Technical Files.
  • Plan coordinator and prepare all regulatory documents in support of existing product life-cycle management, including PMA Supplements and Technical File updates. 
  • Manage registration through collaboration with global RA peers
  • Review and approve test reports and associated technical documentation
  • Support international product registration regulatory colleagues
  • Provide input to product development teams on standards assessments
  • Work with Clinical Affairs on strategy for clinical studies, submit study applications and annual reports. 

Qualifications

  • Bachelor’s degree in Engineering, biology, or science related field preferred.
  • Minimum 7 years’ experience in regulatory affairs.
  • Experience with successful preparation of global registration
  • Proven ability to contribute creative yet practical solutions to problems
  • Strong cross-organizational collaboration with internal stakeholders and external regulatory agencies

 

 

#LI-MK1

 

  

 

This position may be available in the following location(s): US - Clearwater, FL

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.