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von: KVALITO AG
At KVALITO Consulting, a women-owned business founded in 2013, we are dedicated to transforming the life sciences and healthcare sectors through tailored, innovative solutions that prioritize quality and people. Our purpose-driven team is agile and adaptable, ready to learn and respond to evolving business needs. Join us in creating transformative solutions that empower our clients and leave a legacy of excellence in consulting.
KVALITO Life Science Consultant, Regulatory Affairs Specialist – Medical Devices
Date: 03/03/2025 to 31/12/2025
The core mission of the Regulatory Affairs Specialist is to ensure compliance with EU Medical Device Regulation (MDR 2017/745) and facilitate the submission and approval processes for combination products involving medical device components. This role plays a critical part in managing regulatory submissions, ensuring alignment with Notified Bodies, and supporting product safety and efficacy for patient-focused therapies.
Oversee Notified Body Opinion (NBOp) submissions for products such as VAY736, TQJ230, Cosentyx, and Kesimpta, ensuring compliance with regulatory timelines and requirements.
Track submission progress, align with stakeholders, and escalate issues to senior leadership when necessary.
Support responses to Notified Body queries and EMA requirements during the NBOp review process.
Support the planning of NBOp submissions and interactions with Notified Bodies across multiple product lines.
Review design control documentation to ensure compliance with MDR standards.
Identify and implement process improvements to streamline regulatory activities and maintain quality standards.
Bachelor’s degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, or a related field.
Minimum 5+ years of experience in Regulatory Affairs or a similar role, with a focus on medical devices or combination products.
Exceptional organisational and project management skills, with the ability to handle multiple submissions simultaneously.
Fluency in English (written and spoken) is required.
Attention to Detail: High accuracy in documentation and compliance processes.
Thrives in a fast-paced, dynamic environment with shifting priorities.
Global client projects in a multinational environment
Flexible working hours and home office
Individual professional development, training, and coaching
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