SGS Australia / Fulcrum Robotics is looking for an In-house Clinician – Dental (Part-time, 40% FTE) to join our clinical team. You will be a key member of the Notified Body, providing essential clinical oversight to ensure the assessment of Medical Devices complies with EU MDR regulations. This role sits within the global leader in inspection, verification, testing, and certification.
What You'll Do
- Act as the primary clinical expert within SGS Medical Device certification activities.
- Review and scientifically challenge clinical data within clinical evaluations and associated investigations.
- Coordinate and guide external clinical experts in their clinical assessments.
- Draw records and reports regarding clinical assessments and make recommendations to the Notified Body’s decision maker.
- Develop, update, and maintain training packages focused on clinical evaluation assessments.
- Provide clinical input into client queries and meetings.
- Act as a final reviewer on clinical aspects according to EU MDR regulation.
What We're Looking For
- A qualified Dentist with a minimum of two years of working experience.
- University degree in Dentistry plus further academic training in clinical research or a medical device-related area.
- Fluent in English, both reading and writing.
Nice to Have
- Knowledge of the Medical Device Regulation (MDR) and relevant guidance documents (e.g., MDCG, MEDDEV).
- At least two years experience assessing clinical data for medical devices within a Notified Body.
- Experience working with a Notified Body and/or writing or assessing Clinical Evaluation Reports (CERs).
Team & Environment
You will work together with a group of clinicians and specialized product reviewers.
Benefits & Compensation
- Remote working environment.
- Opportunity to work with a global leader in inspection, verification, testing, and certification.
- Collaborative and inclusive work environment.
- Opportunities for professional growth and development.
Work Mode
This is a global role.
Our culture is built on an open corporate and international environment, high professional standards, and a long-term investment in our employees. Our business principles include Integrity, Health, Safety & Environment, Quality & Professionalism, Respect, Sustainability, and Leadership.
