Job description
Description
The Regulatory Specialist is responsible for supporting product development, ensuring compliance with the relevant regulatory requirements and interactions with regulatory authorities. The successful applicant will collaborate closely with all teams within the organization to fulfill DeepHealth’s mission.
Requirements
Essential Duties and Responsibilities
Plan, define and coordinate relevant process related to product Regulatory approval, including but not limited, FDA clearance, and 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, including specific national requirements.
Create and ensure maintenance of technical documentation, as required for obtaining and/or maintaining regulatory approval/clearance for DeepHealth products; specifically, to support marketing and distribution of DeepHealth products outside of the US.
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.
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.
Minimum Qualifications, Education and Experience
Bachelor’s degree in relevant field (or equivalent experience).
Knowledge and understanding of Medical Devices Regulations (MDR 2017⁄745. MDCG 2019-11, MDCG 2020-1), ISO 13485, and MDSAP (including Canada, Australia, and Brazil), ISO 14971, ISO 62366, IEC 82304-1, IEC 62304.
2 - 4 years working in a regulated industry (FDA and Software as a Medical Device preferred).
Knowledge and experience drafting and submitting various regulatory filings, including but not limited to, Notification of Change requests for the international market.
Experience interacting with Regulatory Authorities.
Knowledge and understanding of pre- and post- market clinical studies, including but not limited to, 21 CFR 812, 21 CFR 50, and 21 CFR 56.
Excellent written and oral communication skills.
Quality Standards
Communicates, cooperates, and consistently functions professionally and harmoniously with all levels of supervision, co-workers, patients, visitors, and vendors.
Demonstrates initiative, personal awareness, professionalism and integrity, and exercises confidentiality in all areas of performance.
Follows all local, state and federal laws concerning employment to include but not limited to: I-9, Harassment, EEOC, Civil rights and ADA.
Follows OSHA regulations, RadNet and site protocols, policies and procedures.
Follows HIPAA, compliance, privacy, safety and confidentiality standards at all times.
Practices universal safety precautions.
Promotes good public relations on the phone and in person.
Adapts and is willing to learn new tasks, methods, and systems.
Reports to work regularly as scheduled; consistently punctual with respect to working hours, meal and rest breaks, and maintains satisfactory personal attendance in accordance with RadNet guidelines.
Consistently adheres to the time management policies and procedures.
Completes job responsibilities in a quality and timely manner.
MISSING PHYSICAL REQUIREMENTS
This position requires sitting for an extensive period of time.
Working Environment
This position will have the ability to work remotely.
ACCOMMODATIONS
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.
