We are looking for an experienced and meticulous
Regulatory Affairs Senior
to take full ownership of all regulatory activities for our portfolio of In Vitro Diagnostic (IVD) devices. This is a high-impact role where you will be tasked with leading our compliance strategy for the European and global markets. Your core focus will be maintaining and evolving our Quality Management System (QMS), mastering the complexities of the IVDR and FDA regulations, managing all technical documentation, and successfully interfacing with Notified Bodies and Health Authorities. You will be the definitive voice ensuring that our innovative devices meet every global standard, driving market success.
Key Responsibilities
:
* Define and implement regulatory strategies for new and existing products.
* Ensure continuous compliance with applicable regulations (IVDR, MDR, ISO 13485, FDA, etc.).
* Prepare and maintain regulatory documentation and Technical Files/Design Dossiers.
* Be responsible for the implementation and maintenance of the Quality Management System (QMS).
* Act as the Person Responsible for Regulatory Compliance (PRRC) (where applicable).
* Act as the Vigilance Manager (or equivalent).
* Lead communication with Regulatory Authorities and Notified Bodies.
* Monitor regulatory changes and ensure timely adaptation of internal processes.
* Conduct internal reviews to confirm compliance with the QMS and regulatory standards.
* Support internal teams (R&D, Clinical) to ensure compliance throughout the product lifecycle.
* Coordinate and guide during audits, inspections, and certification processes.
* Train and advise team members on good regulatory practices.
Requirements
:
* Education: University degree in Life Sciences, Pharmacy, Biotechnology, Biomedical Science, Engineering, or related fields.
* Experience: 4 to 6 years of experience in regulatory affairs for medical devices or diagnostics.
* Regulatory Knowledge: Demonstrated experience with IVDR and/or FDA regulations.
* Language: Excellent verbal and written communication skills in English.
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Randstad promotes equal employment opportunities through diverse and inclusive teams. That is why, in our processes, we ensure the inclusion of all individuals, regardless of their personal circumstances, gender, sexual orientation, ethnicity, culture, age, religion, or disability.
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