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Junior Quality Assurance and Regulatory Affairs Associate
Il y a 3 mois
DentalMonitoring is a MedTech scale-up operating in a rapidly evolving medical sector. We are seeking new talent to contribute to our mission.
What distinguishes Dental Monitoring's offerings for its clients?
✦ Our software as a service (SAAS) enhances and streamlines orthodontic treatment for both practitioners and patients through our application and patient platform.
✦ DentalMonitoring pioneers AI-driven technology within the oral healthcare industry.
✦ With over 200 patents filed on our innovations, we are at the forefront of transforming the orthodontic experience.
✦ Our innovative tool, the Scanbox, facilitates easy intraoral observations for both patients and practitioners.
✦ Our patients regain their confidence and smiles.
Dental Monitoring has been recognized in the Next40 for two consecutive years.
This position is suitable for entry-level candidates.
Responsibilities of the Junior RA/QA Associate
✦ Engage in communication both internally and externally to inform Dental Monitoring colleagues and clients about quality and regulatory inquiries.
✦ Ensure the quality management system is upheld or revised in accordance with ISO 13485, ISO 27001, and other relevant quality or regulatory standards (MDSAP).
✦ Spearhead the implementation of quality system software within the organization to enhance traceability, maintenance, and efficiency by automating low-value tasks.
✦ Analyze corporate quality KPIs and prepare quality management reviews, overseeing essential quality processes such as Internal/External audits, Supplier Quality, and CAPA.
✦ Manage Post-Market Surveillance (including complaints and field actions), Change Control, Data & Documentation Management, Training, and Product Release.
✦ Formulate regulatory strategies in a dynamic and innovative sector: healthcare-specific software and mobile applications, collaborating closely with marketing, R&D, and clinical teams to clarify regulatory requirements.
✦ Prepare and track medical device registration applications for targeted markets (including registration applications and amendments) such as CE countries, Australia, the US, and others.
✦ Maintain registrations post-market launch.
✦ Facilitate communication with regulatory authorities.
✦ Define labeling requirements and review promotional materials.
✦ Ensure continuous regulatory and quality assurance monitoring.
The above responsibilities are not exhaustive; additional duties may be assigned.
Qualifications for Success in this Role
✦ 0-2 years of experience in a related field.
✦ Degree in Engineering, Pharmacy, or a Master’s in Regulatory Affairs or a Medical/Scientific discipline.
✦ Strong communication skills and the ability to build relationships with both internal and external stakeholders.
✦ Excellent organizational, meticulous, and analytical abilities.
✦ Proficiency in both oral and written English.
Preferred Qualifications
✦ Experience in a startup or scale-up environment.
✦ Knowledge of international regulations beyond CE & USA for medical devices, such as MDSAP.
✦ Proficiency in languages other than French and English.
✦ Experience in the dental sector.
Our Work Environment
At Dental Monitoring, our employees excel because:
✦ We value collaboration. Our team of researchers, doctors, developers, sales professionals, and all stakeholders work together to prioritize our customers.
✦ DentalMonitoring is a diverse, multicultural organization, with over 20 nationalities represented in our teams.
What We Offer Our Employees
✦ Your ideas will be valued. Our culture encourages initiative, ownership, and constructive feedback.
✦ We are dedicated to supporting your professional growth, recognizing that continuous learning is essential.
✦ We emphasize the importance of work-life balance.
✦ Our employee benefits include: health insurance, meal cards, stock options, hybrid work arrangements, gym memberships, corporate events, and a referral program.
***This role is office-based.***
DentalMonitoring is an equal opportunity employer, fostering an inclusive and intercultural workplace. The diversity of our teams is one of our greatest strengths. We actively welcome applications from individuals with disabilities and are committed to providing necessary accommodations.
