Ophthalmic Regulatory Strategist

Unlock Your Potential as a Regulatory Affairs Manager in D105 WaveLight GmbH Company

We are driven by the meaningful work we do to help people see brilliantly. As a global leader in eye care, we innovate boldly, champion progress, and act with speed.

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.

A Day in the Life:

• Develop and implement global regulatory strategies for the approval and lifecycle management of medical devices, focusing on our 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, 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 7+ years of experience 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

About Compensation:

Our competitive compensation package includes a salary range of approximately €80,000 to €120,000 per year, depending on qualifications and experience, plus additional benefits such as hybrid work arrangements, opportunities for professional growth, and collaboration with a dedicated team in a dynamic workplace.

Your Benefits:

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

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