Quality Assurance and Regulatory Affairs Specialist
il y a 7 jours
About the Role
DentalMonitoring is a MedTech scale-up in a fast-growing medical field. We are looking for a talented individual to join our team as a Quality Assurance and Regulatory Affairs Specialist.
Key Responsibilities
- Participate in communication inside and outside the company to educate colleagues and clients regarding quality and regulatory requests.
- Ensure the quality system is maintained or updated in compliance with ISO and other applicable quality or regulatory requirements.
- Lead the use of a quality system software to improve traceability, maintenance, and avoid wasting time by automating low-added-value actions.
- Review corporate quality KPI and prepare quality management reviews, including oversight of key quality processes.
- Define regulatory strategies in an unclear, still-moving innovative field: healthcare-specific software and mobile applications.
- Prepare and follow-up medical device registration applications for targeted markets.
- Maintain registrations after the product is placed on the market.
- Ensure communication with competent authorities.
- Define labelling and check promotional material.
- Ensure the needed regulatory and quality assurance watch.
Requirements
- Years of experience in a related area.
- Engineering degree or pharmacist or MSC in Regulatory Affairs or Medical/Scientific field.
- Ability to communicate effectively and build relationships with internal/external stakeholders.
- Excellent organisation, rigour, and analytical skills.
- Proficient in oral and written English.
About Us
DentalMonitoring is a diverse, multicultural company with more than nationalities throughout our teams. We are committed to supporting your professional development and offer a range of benefits, including Alan health insurance, Swile card, Free shares plan, Hybrid work, Gymlib, Corporate events, and Referral policy.
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