Huidige banen gerelateerd aan Senior Regulatory Affairs Specialist for IVD Products - Amsterdam, Noord-Holland - Michael Page
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Senior Regulatory Affairs Specialist for IVD Products
2 maanden geleden
A leading pharmaceutical organization with extensive expertise in the development and commercialization of In Vitro Diagnostic (IVD) products. This company is dedicated to providing high-quality solutions that enhance patient care. The Regulatory Affairs team comprises seven skilled professionals.
Position Overview
As a Regulatory Affairs Specialist, you will take charge of assembling and overseeing all components related to the registration documentation for In Vitro Diagnostics (IVDs). You will work autonomously while also collaborating with various departments, including Production, Product Development, and Marketing & Sales.
Your in-depth knowledge of current regulations governing IVDs will be crucial in updating registration files and ensuring compliance with all necessary standards and quality benchmarks.
Your Responsibilities Will Include:
- Preparing and revising technical documentation to align with ISO 13485, IVDR, and other international regulations.
- Interpreting and applying both national and international regulations to develop comprehensive registration files.
- Providing guidance and support to different departments on regulatory issues, including collaboration with the scientific R&D team on new or expanded product claims.
- Overseeing the creation and review of essential documents such as Instructions For Use (IFU), brochures, and product-specific labeling in accordance with legal requirements.
- Evaluating modifications in production processes or product documentation.
- A university degree in Medical Biology, Medicine, or a related discipline such as Biochemistry, Biomedical Sciences, Pharmacy, or Life Science & Technology.
- A minimum of two years of experience as a Regulatory Affairs Officer with IVD or comparable products.
- Familiarity with relevant procedures, products, and manufacturing processes (IVDD/IVDR).
- Understanding of international regulations applicable to IVDs.
- Experience in conducting performance assessments for IVDs.
- Knowledge of ISO 13485 quality management systems; audit experience is advantageous but not mandatory.
- Strong verbal and written communication skills in English.
- A flexible, detail-oriented, and analytical thinker with a collaborative mindset.
- A distinctive work environment
- Full-time position of 36 hours
- Competitive remuneration package
- 13th-month bonus
- Opportunities for training and professional development
- Reimbursement for travel expenses
