What are the responsibilities and job description for the Regulatory Affairs Specialist (Mammo) position at DeepHealth?
The Regulatory Specialist (US) is responsible for supporting DeepHealth's product and product development, ensuring compliance with the relevant regulatory requirements and interactions with regulatory authorities.
As the Regulatory Specialist, this position will :
- Plan, define and coordinate relevant process related to product Regulatory approval, including but not limited to, FDA clearance, and / or CE Marking.
- Actively liaise and closely collaborate with engineering and product teams to ensure regulatory compliance for product markets.
- Provide regulatory guidance to the development teams for registration of products.
- Create and ensure maintenance of technical documentation (such as clinical evaluation reports, risk management reports, 510(k) notification) as required for obtaining and / or maintaining regulatory approval / clearance for DeepHealth products.
- Plan, execute and document (clinical) risk assessment sessions with relevant internal and external experts.
- Work with the clinical teams to ensure compliance for pre- and post-market clinical studies in support of DeepHealth products and product changes.
- Enforce compliance to applicable standards and escalate to appropriate authorities if needed.
- Ensuring timely submission of adverse events to the appropriate regulatory bodies.
Please Note : This is not an exhaustive list of all duties, responsibilities and requirements of the position described above. Other functions may be assigned, and management retains the right to add or change duties at any time.
Qualifications include :
Working conditions
This position is based in the United States in a typical office setting.
This position will have the ability to work remotely.
Physical requirements
This position often requires sitting, standing, walking, bending, twisting, reaching with hands and arms, using hands and fingers, handling, or feeling, speaking, listening, and high-level cognitive thinking. Also, must be able to lift up to 10 pounds occasionally. The position requires the ability to travel (~10% of time), drive a vehicle, and utilize other forms of transportation.
