Regulatory Affairs Specialist
il y a 1 semaine
About the Role
DentalMonitoring is a MedTech scale-up in a fast-growing medical field. We are seeking a highly skilled Regulatory Affairs Specialist to join our team.
Key Responsibilities
- Participate in communication inside and outside the company to educate colleagues and clients regarding quality & regulatory requests.
- Ensure that 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 automation of low added value actions.
- Review corporate quality KPI and prepare quality management reviews, including Oversight of key quality processes, including Internal/External audit, Supplier Quality, CAPA, Post-Market Surveillance (Complaints, Field Action), Change Control, Data & Documentation Management, Training and Product Release.
- Define the regulatory strategies in an unclear, still moving innovative field: healthcare specific software and mobile applications. This includes a close collaboration with marketing, R&D and clinical departments to explain regulatory requirements.
- Prepare and follow-up medical device registration applications for the targeted markets (registration applications, amendments...), such as CE countries, Australia, US, and others.
- Maintain registrations after the product is placed on the market.
- Ensure communication with competent authorities.
- Define the labelling and check promotional material.
- Ensure the needed regulatory & quality assurance watch.
Requirements
- **Years of Experience**: Minimum ** years of experience in related area.
- **Education**: Engineering Degree or Pharmacist or MsC in Regulatory Affairs or Medical/Scientific field.
- **Skills**: 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 thrive because we are collaborators, and our team of researchers, doctors, developers, salespeople and all of our stakeholders work together to put our customers first.
What We Offer
- Your ideas will be heard. Our culture promotes initiatives, ownership and feedback.
- Everyone is committed to supporting your professional development because we understand that no one can know everything.
- We place significant importance on the quality of work-life balance.
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