Regulatory Affairs Specialist
il y a 2 semaines
About the Role
DentalMonitoring is a MedTech scale-up in the fast-growing medical field of orthodontic treatment. We are seeking a skilled Regulatory Affairs Specialist to join our team.
Key Responsibilities
- Participate in internal and external communication to educate colleagues and clients on quality and regulatory requirements.
- Maintain and update the quality system in compliance with ISO and MDSAP standards.
- Lead the use of quality system software to improve traceability, maintenance, and automation of low-value actions.
- Review corporate quality KPIs and prepare quality management reviews, including oversight of key quality processes.
- Define regulatory strategies in the healthcare software and mobile applications field, collaborating with marketing, R&D, and clinical departments.
- Prepare and follow up on medical device registration applications for targeted markets, including CE countries, Australia, and the US.
- Maintain registrations after product launch and ensure communication with competent authorities.
- Define labeling and check promotional material.
- Ensure regulatory and quality assurance watch.
Requirements
- Years of experience in a related area.
- Engineering degree or pharmacist or master's degree in regulatory affairs or medical/scientific field.
- Ability to communicate effectively and build relationships with internal/external stakeholders.
- Excellent organization, rigor, and analytical skills.
- Proficient in oral and written English.
About Us
DentalMonitoring is a diverse, multicultural company with over nationalities throughout our teams. We value collaboration, initiative, and feedback, and we are committed to supporting your professional development.
What We Offer
- Your ideas will be heard and valued.
- Everyone is committed to supporting your professional development.
- We prioritize work-life balance and offer various perks, including health insurance, a Swile card, free shares, hybrid work, and more.
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