Regulatory Affairs Specialist
Vor 5 Tagen
About KVALITO AG
KVALITO Consulting is a women-owned business that prioritizes quality and people in the life sciences and healthcare sectors. Our purpose-driven team utilizes technology and human-centric approaches to drive impactful results.
We are dedicated to creating lasting, high-value relationships with our clients and empowering high-performing individuals to reach their full potential. Our agile and adaptable culture fosters a results-oriented, ambitious, and caring environment.
Job Description:
The Regulatory Affairs Specialist plays a critical part in managing regulatory submissions, ensuring alignment with Notified Bodies, and supporting product safety and efficacy for patient-focused therapies.
This role oversees Notified Body Opinion (NBOp) submissions for combination products involving medical device components, ensuring compliance with EU Medical Device Regulation (MDR 2017/745). The specialist tracks submission progress, aligns with stakeholders, and escalates issues to senior leadership when necessary.
Key Accountabilities:
- Submission Management: Oversee NBOp submissions for combination products, ensuring timely and compliant execution.
- Progress Tracking: Monitor submission progress, address challenges, and propose practical solutions.
- Documentation Review: Compile, review, and submit dossiers to Notified Bodies, ensuring completeness and accuracy.
- Gap Assessments: Conduct gap assessments of Design History Files (DHF) and source documentation, addressing regulatory requirements and Notified Body expectations.
- Liaison Role: Act as a primary liaison between internal teams, Notified Bodies, and regulatory authorities like the European Medicines Agency (EMA).
Requirements:
The ideal candidate holds a Bachelor's degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, or a related field. A minimum of 5+ years of experience in Regulatory Affairs or a similar role, with a focus on medical devices or combination products, is required. Proven EU MDR 2017/745 expertise and familiarity with Notified Body submission processes are essential.
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