Regulatory Affairs Medical Device Specialist

Pracovní nabídka

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 role of Regulatory Affairs Specialist is to assure regulatory support around the world. Coordinates cooperation between local/regional temas and medival devices manufacturers to assure timely delivery of the regulatory documentation of all medical devices in line with corporate strategies and notification/submission timelines and in compliance with applicable regulations.

Responsibilities:

- Organize, track and support requests from local/regional Regulatory teams

- Communication with legal manufacturers and manufacturing sites

- Project plan execution and regulatory compliance oversight

- Regulatory Affairs representative on cross-functional committees and projects teams

- Conducting Regulatory Impact assessment for product or process changes

- Artworks updates coordination

- Analysis of marketing materials from regulatory point of view

- Preparing and maintenance procedure

- Support/participate in health authority interactions, as appropriate

- Establish audit readiness and be prepared to present at audits, if needed

Requirements:

- University degree in life science, medical science, pharmaceutical, engineering, chemistry or biotechnology

- At least 3 years of experience in regulatory affairs, quality or compliance with medical devices

- Advanced knowledge of medical device regulations and environment (EU MDD & MDR, Russia/CIS, Middle East, China, etc.)

- Strong organizational and communication skill, self-motivation, 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

- Fluent English

- Advanced knowledge of MS Office

- Experience working in cross-functional teams

- Strong teamwotk and the ability to influence without authority