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Regulatory Affairs Manager Medical Devices (m / f / d) with Advanced Expertise

Regulatory Affairs Manager Medical Devices (m / f / d) with Advanced Expertise

D105 WaveLight GmbH CompanyErlangen, Germany
Vor 5 Tagen
Anstellungsart
  • Vollzeit
Stellenbeschreibung

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. In this high-impact role, you’ll be at the forefront of navigating global regulations for cutting-edge 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 :

  • Degree in a related field and a proven track record of 7+ years in the medical device industry
  • Comprehensive knowledge of European, US, and Canadian medical device regulations
  • Fluency in English and German (both written and verbal)
  • Strong analytical skills, attention to detail, and expertise in MS Office tools
  • Excellent communication and negotiation skills to foster effective relationships with global authorities and cross-functional teams

    • NICE TO HAVE :

  • Familiarity with Asia-Pacific and / or Latin American medical device regulations
  • Experience with electrical / software-driven medical devices and standalone software medical devices

    • HOW YOU CAN THRIVE AT ALCON :

  • Thrive in a hybrid work environment with a competitive compensation package
  • Play a key role in the entire product lifecycle, from innovation to market success
  • Collaborate with a dedicated, high-performing team in a dynamic, supportive workplace
  • Join a global leader in medical technology, where your work contributes to life-changing advancements in eye care