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Senior Regulatory Affairs Specialist, Latina
Job Details:
* Client:
* Location:
* Job Category: Other
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* EU work permit required: Yes
Job Reference:
142956969828601036833711
Job Views:
2
Posted:
26.04.2025
Expiry Date:
10.06.2025
Job Description:
Cosmo IMD, a division of Cosmo Pharmaceutical, specializes in AI-integrated medical devices. We have developed expertise in hardware and software design, AI development, data harvesting, clinical development, and regulatory compliance in the US and worldwide. Our team manufactures GI Genius, the world’s first real-time AI medical device distributed by Medtronic.
About the role:
The Regulatory Affairs department ensures compliance with applicable regulations, focusing on vigilance, reporting, and updates analysis.
Key Responsibilities:
* Assess medical device safety, review risk management activities, and evaluate health hazards and clinical reports.
* Manage and document post-marketing safety data, complaints, and safety reports.
* Handle vigilance reporting according to country requirements and investigate failures from a regulatory perspective.
* Collaborate with customers and monitor external trends and issues.
* Ensure regulatory compliance during product design and development.
* Represent the department during audits and regulatory interactions.
* Manage communications with authorities and stakeholders.
* Update and implement regulatory procedures and promote a culture of compliance.
Qualifications, Skills, and Abilities:
* Bachelor’s degree in medicine, pharmacology, biomedical sciences, or related fields; higher degrees are a plus.
* At least 5 years of regulatory affairs experience in the medical device industry, including 2 years in vigilance reporting per 21 CFR Part 803 and EU MDR/MDD.
* Proficiency in English; deep knowledge of EU and US regulations, standards like ISO 13485, ISO 14971, ISO 62304.
* Understanding of software, AI, and endoscopy technologies.
* Knowledge of EU Regulation 2024/1689 is advantageous.
Personal Attributes:
* Strong analytical skills and attention to detail.
* Ability to work independently and in teams.
* Adaptability to a dynamic, innovative environment.
Equal Opportunity Statement: The research complies with Legislative Decree 198/2006.
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