Regulatory Affairs Strategy Sr. Associate (mfd) – Medical Devices
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Job Location:
Monthly Salary:
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
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 wholly-owned subsidiary of Alcon enabling gentle and highly precise correction of vision impairment.
We are looking for a talented and strategic Regulatory Strategy Sr. Associate (m/f/d) to join our Global Regulatory Affairs Team in Erlangen. In this impactful role youll support regulatory activities for the Wavelight portfolio helping navigate global requirements for innovative medical technologies. Youll contribute to regulatory submissions ensure compliant promotional materials assist with lifecycle updates and collaborate across teams to keep products aligned with regulatory standards playing a key part in bringing safe highquality solutions to patients worldwide.
In this role a typical day will include:
- Contribute to regulatory strategy development by supporting activities that help obtain and maintain product approvals for the Wavelight portfolio ensuring alignment with global and local requirements.
- Prepare and coordinate regulatory submissions including registrations renewals and updates by collaborating with internal teams manufacturing sites regulatory agents and health authorities.
- Review promotional materials and labeling to ensure compliance with legal ethical and industry standards while maintaining accurate and uptodate technical documentation and dossiers.
- Support product lifecycle activities by assessing regulatory impacts of changes assisting with regulatory pathways for modifications and ensuring continuous compliance across the medical device portfolio.
- Facilitate crossfunctional and authority interactions by providing regulatory input addressing countryspecific queries and serving as a key point of communication to help ensure timely approvals.
- Maintain strict compliance with GxP and quality systems by following SOPs keeping thorough documentation completing required training and contributing to audits inspections and ongoing process improvements.
WHAT YOULL BRING TO ALCON:
Degree in Life Sciences Biomedical Engineering Pharmacy or a related field
- Fluency in English and German (both written and verbal)
- 5 years of experience working with global medical device submissions (e.g. EU MDR technical Documentation FDA 510(k)/PMAs Health Canada Class II & III ISO) with a strong motivation to continue expanding regulatory expertise
- This role is well suited for a Regulatory Affairs professional with handson experience who is ready to take on greater ownership of key market submissions and crossfunctional regulatory coordination
- Ability to work with technical documentation regulatory submissions and compliancerelated materials with strong attention to detail
- Solid communication skills to collaborate effectively with crossfunctional teams and interact professionally with regulatory agencies
- Strong organizational and timemanagement abilities to support multiple tasks submissions and deadlines in a structured environment
- Commitment to quality including adherence to GxP SOPs accurate documentation practices and continuous learning through required trainings
HOW YOU CAN THRIVE AT ALCON:
- 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
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Required Experience:
Senior IC
Key Skills
About Company
Our mission is to provide innovative vision products that enhance quality of life by helping people see better. From vision research to eye health, learn more at Alcon.com.
