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Regulatory affairs specialist • hochstadt an der aisch
Regulatory Affairs Manager Medical Devices (m / f / d) with Advanced Expertise
D105 WaveLight GmbH CompanyErlangen, GermanySpecialist Pricing
BNP ParibasBavière(Senior) Manager, Medical Science Liaison, Therapy Development, Transcatheter Mitral and Tricuspid Therapies (Germany)
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FluenceErlangen, GermanyRegulatory Affairs Manager Medical Devices (m / f / d) with Advanced Expertise
D105 WaveLight GmbH CompanyErlangen, Germany- Vollzeit
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.
WaveLight GmbH is a global leader in developing and producing innovative laser systems for use in eye surgery, as well as surgical planning and image guidance for cataract surgeries. Since 2009, WaveLight has been a wholly-owned subsidiary of Alcon, enabling gentle and highly precise correction of vision impairment.
We are looking for a talented and strategic Regulatory Affairs Manager (m / w / d) to join our Global Regulatory Affairs - Global Instrumentation Team in Erlangen or Berlin-Teltow. In this high-impact role, you’ll be at the forefront of navigating global regulations for ophthalmic refractive surgery equipment, diagnostic devices, and software solutions. This is your opportunity to lead the charge in achieving market success for groundbreaking technologies, while contributing to life-changing innovations.
In this role, a typical day will include :
- Develop and implement global regulatory strategies for the approval and lifecycle management of medical devices, with a focus on the WaveLight portfolio
- Manage global registration processes by coordinating, preparing, and reviewing submissions to ensure compliance with international regulations
- Create and maintain technical documentation and global dossiers to maintain device registrations and support lifecycle projects
- Strategically collaborate and negotiate with regulatory authorities, acting as the liaison between project teams and health agencies
- Optimize product labeling and Instructions for Use (IFU) to ensure market access and compliance, while addressing country-specific submission queries
- Lead the review and approval processes for regulatory changes, supporting external audits and regulatory inspections to ensure global compliance
WHAT YOU’LL BRING TO ALCON :
NICE TO HAVE :
HOW YOU CAN THRIVE AT ALCON :