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 Specialist is responsible for providing regulatory support across global markets.
The role coordinates collaboration between local and regional teams and medical device manufacturers to ensure the timely delivery of regulatory documentation, aligned with corporate strategies, notification and submission timelines, and all applicable regulatory requirements.
This position is a hybrid role based in the Dublin, citywest office, with 3 days in the office and 2 days from home.
KEY ACTIVITIES / RESPONSIBILITIES
Coordinate the regulatory activities related to new markets expansion and MOB implementation.
Contribute to the planning and tracking of regulatory submissions across multiple regions.
Maintain project timelines, trackers, and documentation to support efficient execution of regulatory activities.
Collaborate with global and regional Regulatory Affairs teams to facilitate alignment on submission timelines and requirements.
Monitor progress of regulatory deliverables and follow up with stakeholders to support timely completion of activities.
Represent Regulatory Affairs on cross-functional technical committees.
Identify potential risks or delays in regulatory timelines and communicate them to relevant stakeholders.
Prepare project updates, reports, and documentation to support internal communication and governance processes.
Contribute to continuous improvement of regulatory project coordination processes and tools.
QUALIFICATIONS
University degree in life science, medical science, pharmaceutical, engineering, chemistry or biotechnology.
At least 2 years of experience in regulatory affairs, quality or compliance with Medical Devices.
Advanced knowledge of medical device international regulations and environment.
Strong organizational and communication skill, self-motivated, detail-oriented and capable to work independently.
Capability to react quickly to changes in the regulatory environment.
Precise planning and execution to achieve accurate and timely results.
Ability to manage multiple priorities.
Self-motivated and capable of working with supervision and guidance.
Fluent in English (written and spoken).
Advanced knowledge of MS Office.
Bausch & Lomb is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.
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