Junior Quality Assurance and Regulatory Affairs Associate

il y a 3 semaines


Paris, Île-de-France DentalMonitoring Temps plein
About DentalMonitoring
DentalMonitoring is a rapidly expanding MedTech company operating in a dynamic healthcare sector. We are currently seeking a motivated individual for the position of Junior Quality Assurance and Regulatory Affairs Associate.

Key Responsibilities
✦ Engage in effective communication both internally and externally to inform colleagues and clients about quality and regulatory matters.
✦ Maintain and update the quality management system in accordance with ISO 13485, ISO 27001, and other relevant quality and regulatory standards (including MDSAP).
✦ Facilitate the implementation of quality management software to enhance traceability and efficiency, minimizing time spent on low-value tasks through automation.
✦ Analyze corporate quality Key Performance Indicators (KPIs) and prepare quality management reviews, overseeing critical quality processes such as Internal/External audits, Supplier Quality, and Corrective and Preventive Actions (CAPA).
✦ Conduct Post-Market Surveillance activities, including handling complaints, managing field actions, and overseeing Change Control, Data & Documentation Management, Training, and Product Release.
✦ Develop regulatory strategies in a rapidly evolving field, focusing on healthcare-specific software and mobile applications, in collaboration with marketing, R&D, and clinical teams to clarify regulatory requirements.
✦ Prepare and manage medical device registration applications for target markets, including submissions and amendments, while ensuring effective communication with regulatory authorities.
✦ Maintain vigilance regarding regulatory and quality assurance developments.

Qualifications
• Degree in Engineering, Pharmacy, or a Master’s in Regulatory Affairs or a related Medical/Scientific field.
• Proficient in both oral and written English.
• Familiarity with international regulations beyond CE and USA standards for medical devices, such as MDSAP.
• Knowledge of additional languages beyond French and English is a plus.

Our Commitment
We are dedicated to your professional growth, recognizing that continuous learning is essential. We value work-life balance and offer a range of benefits including health insurance, meal vouchers, stock options, hybrid work arrangements, fitness memberships, corporate events, and a referral program.

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