Regulatory Affairs Manager Medical Devices mfd with Advanced Expertise
Regulatory Affairs Manager Medical Devices mfd with Advanced Expertise
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Job Description
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 youll 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 whollyowned 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 BerlinTeltow. In this highimpact role youll 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 lifechanging 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 countryspecific submission queries
- Lead the review and approval processes for regulatory changes supporting external audits and regulatory inspections to ensure global compliance
WHAT YOULL 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 crossfunctional teams
NICE TO HAVE:
- Familiarity with AsiaPacific and/or Latin American medical device regulations
- Experience with electrical/softwaredriven 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 highperforming team in a dynamic supportive workplace
- Join a global leader in medical technology where your work contributes to lifechanging advancements in eye care
Alcon Careers
See your impact under https://alcon/aboutus/careers
ACHTUNG: Wenn Sie derzeit ein aktiver Mitarbeiter (intern oder extern ber Zeitarbeit bzw. Dienstleister) bei Alcon sind klicken Sie bitte auf den entsprechenden Link unten um sich auf der internen Karriereseite zu bewerben. Vielen Dank.
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Required Experience:
Manager
Employment Type
Full-Time
