Senior Regulatory Affairs Specialist (CoE Medical Devices)

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.

Currently we are looking for:

Senior Regulatory Affairs Specialist (CoE Medical Devices):

Objectives of the position

The role of Senior Regulatory Affairs Specialist is to assure regulatory support around the world. Coordinates cooperation between local/regional teams and medical device 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. Maintain complex projects and proactive planning projects for key markets with a broad scope, decision-making responsibility, and a strong impact on business outcomes. The position requires independent prioritization and focus on complex regulatory and cross-functional challenges.

Responsibilities

• Communication with legal manufacturers and manufacturing sites.
• Project plan execution and regulatory compliance oversight.
• Regulatory Affairs representative on cross-functional technical committees and project teams.
• Conducting Regulatory impact assessment for product or process changes.
• Prioritize important projects
• Continuous optimization of registration submissions database tools and tracking systems
• Approving promotional materials
• Identifying, managing, and escalating critical issues to senior stakeholders in a timely manner

Candidate profile

• 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.
• Project management skills will be an asset.
• Advanced knowledge of medical device regulations and environment (EU  MDD & MDR, Russia/CIS, Middle East, China, LATAM, APAC etc.).
• 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.
• Fluent in English and Czech (written and spoken).
• Advanced knowledge of MS Office.
• Experience working in cross-functional teams.
• Strong teamwork and the ability to influence without authority.