Exempt Job Summary The Sr. Regulatory Affairs Specialist is responsible for supporting DeepHealth's product and product development and regulatory activities to commercialize new digital products ...
Exempt Job Summary The Sr. Regulatory Affairs Specialist is responsible for supporting DeepHealth's product and product development and regulatory activities to commercialize new digital products ...
Sr. Regulatory Affairs Spclst
Somerville, MA · On-site
$120K - $165K/yr
Exempt Job Summary The Sr. Regulatory Affairs Specialist is responsible for supporting DeepHealth's product and product development and regulatory activities to commercialize new digital products ...
Quick apply
Sr. Regulatory Affairs Spclst
Somerville, MA · On-site
$120K - $165K/yr
Exempt Job Summary The Sr. Regulatory Affairs Specialist is responsible for supporting DeepHealth's product and product development and regulatory activities to commercialize new digital products ...
Technical Service Engineer
Somerville, MA · On-site
$100K/yr
Follows all DeepHealth policies and procedures. * Follows data privacy, compliance, safety and confidentiality standards at all times. * Practices universal safety precautions. * Promotes good public ...
Technical Service Engineer
Somerville, MA · On-site
$100K/yr
Follows all DeepHealth policies and procedures. * Follows data privacy, compliance, safety and confidentiality standards at all times. * Practices universal safety precautions. * Promotes good public ...
Clinical Data Analyst II
Somerville, MA · On-site
$94K - $115K/yr
Follows all DeepHealth policies and procedures. * Follows data privacy, compliance, safety and confidentiality standards at all times. * Practices universal safety precautions. * Promotes good public ...
Quick apply
Clinical Data Analyst II
Somerville, MA · On-site
$94K - $115K/yr
Follows all DeepHealth policies and procedures. * Follows data privacy, compliance, safety and confidentiality standards at all times. * Practices universal safety precautions. * Promotes good public ...
Clinical Data Analyst II
Somerville, MA · On-site
$94K/yr
Follows all DeepHealth policies and procedures. * Follows data privacy, compliance, safety and confidentiality standards at all times. * Practices universal safety precautions. * Promotes good public ...
Clinical Data Analyst II
Somerville, MA · On-site
$94K/yr
Follows all DeepHealth policies and procedures. * Follows data privacy, compliance, safety and confidentiality standards at all times. * Practices universal safety precautions. * Promotes good public ...
Perform DeepHealth RIS/PACS system updates, upgrades, and maintenance activities. * Conduct pre-sales technical evaluations and provide level-of-effort assessments for customer solutions. * Integrate ...
Perform DeepHealth RIS/PACS system updates, upgrades, and maintenance activities. * Conduct pre-sales technical evaluations and provide level-of-effort assessments for customer solutions. * Integrate ...
Technical Service Engineer
Somerville, MA · On-site
$100K - $110K/yr
Follows all DeepHealth policies and procedures. * Follows data privacy, compliance, safety and confidentiality standards at all times. * Practices universal safety precautions. * Promotes good public ...
Quick apply
Technical Service Engineer
Somerville, MA · On-site
$100K - $110K/yr
Follows all DeepHealth policies and procedures. * Follows data privacy, compliance, safety and confidentiality standards at all times. * Practices universal safety precautions. * Promotes good public ...
Clinical Data Analyst II
Somerville, MA · On-site
$94K - $115K/yr
Follows all DeepHealth policies and procedures. * Follows data privacy, compliance, safety and confidentiality standards at all times. * Practices universal safety precautions. * Promotes good public ...
Clinical Data Analyst II
Somerville, MA · On-site
$94K - $115K/yr
Follows all DeepHealth policies and procedures. * Follows data privacy, compliance, safety and confidentiality standards at all times. * Practices universal safety precautions. * Promotes good public ...
Senior Clinical Studies Associate
Somerville, MA · On-site
$71K/yr
Follows all DeepHealth policies and procedures. * Follows data privacy, compliance, safety and confidentiality standards at all times. * Practices universal safety precautions. * Promotes good public ...
Senior Clinical Studies Associate
Somerville, MA · On-site
$71K/yr
Follows all DeepHealth policies and procedures. * Follows data privacy, compliance, safety and confidentiality standards at all times. * Practices universal safety precautions. * Promotes good public ...
Senior Clinical Studies Associate
Somerville, MA · On-site
$71K - $96K/yr
Follows all DeepHealth policies and procedures. * Follows data privacy, compliance, safety and confidentiality standards at all times. * Practices universal safety precautions. * Promotes good public ...
Senior Clinical Studies Associate
Somerville, MA · On-site
$71K - $96K/yr
Follows all DeepHealth policies and procedures. * Follows data privacy, compliance, safety and confidentiality standards at all times. * Practices universal safety precautions. * Promotes good public ...
Perform DeepHealth Clinical AI product system updates, upgrades, and maintenance activities. * Conduct pre-sales technical evaluations and provide level-of-effort assessments for customer solutions.
Perform DeepHealth Clinical AI product system updates, upgrades, and maintenance activities. * Conduct pre-sales technical evaluations and provide level-of-effort assessments for customer solutions.
Security Operations Engineer
$110K - $120K/yr
Working within DeepHealth's established security frameworks and under the direction of the Director, Security Operations, this position operates and tunes security controls, detection content, and ...
New
Quick apply
Security Operations Engineer
$110K - $120K/yr
Working within DeepHealth's established security frameworks and under the direction of the Director, Security Operations, this position operates and tunes security controls, detection content, and ...
New
Technical Service Engineer
Somerville, MA · On-site
$100K - $110K/yr
Follows all DeepHealth policies and procedures. * Follows data privacy, compliance, safety and confidentiality standards at all times. * Practices universal safety precautions. * Promotes good public ...
Technical Service Engineer
Somerville, MA · On-site
$100K - $110K/yr
Follows all DeepHealth policies and procedures. * Follows data privacy, compliance, safety and confidentiality standards at all times. * Practices universal safety precautions. * Promotes good public ...
Senior Clinical Studies Associate
Somerville, MA · On-site
$71K - $96K/yr
Follows all DeepHealth policies and procedures. * Follows data privacy, compliance, safety and confidentiality standards at all times. * Practices universal safety precautions. * Promotes good public ...
Quick apply
Senior Clinical Studies Associate
Somerville, MA · On-site
$71K - $96K/yr
Follows all DeepHealth policies and procedures. * Follows data privacy, compliance, safety and confidentiality standards at all times. * Practices universal safety precautions. * Promotes good public ...
Follows all DeepHealth policies and procedures. * Follows data privacy, compliance, safety and confidentiality standards at all times. * Practices universal safety precautions. * Promotes good public ...
Follows all DeepHealth policies and procedures. * Follows data privacy, compliance, safety and confidentiality standards at all times. * Practices universal safety precautions. * Promotes good public ...
System Administrator
Greenville, SC · On-site
$60K - $65K/yr
... DeepHealth policies and procedures. • Follows data privacy, compliance, safety and confidentiality standards at all times. • Practices universal safety precautions. • Promotes good public ...
System Administrator
Greenville, SC · On-site
$60K - $65K/yr
... DeepHealth policies and procedures. • Follows data privacy, compliance, safety and confidentiality standards at all times. • Practices universal safety precautions. • Promotes good public ...
Strategic Account Director
Somerville, MA · On-site +1
$120K - $160K/yr
A Strategic Account Director is responsible for driving long-term growth and success within a portfolio of strategic, high-value customer accounts. This role serves as a trusted advisor, providing ...
Strategic Account Director
Somerville, MA · On-site +1
$120K - $160K/yr
A Strategic Account Director is responsible for driving long-term growth and success within a portfolio of strategic, high-value customer accounts. This role serves as a trusted advisor, providing ...
Associate Director Product Marketing
Somerville, MA · On-site +1
$150 - $210/day
... DeepHealth policies and procedures. • Follows data privacy, compliance, safety and confidentiality standards at all times. • Practices universal safety precautions. • Promotes good public ...
Associate Director Product Marketing
Somerville, MA · On-site +1
$150 - $210/day
... DeepHealth policies and procedures. • Follows data privacy, compliance, safety and confidentiality standards at all times. • Practices universal safety precautions. • Promotes good public ...
Demonstration Specialist
$122K - $132K/yr
Responsibilities Job Title: Demonstration Specialist - US Reports to: Commercial Leader FLSA Status: Exempt Job Summary The Demonstration Specialist is responsible for showcasing and promoting ...
Quick apply
Demonstration Specialist
$122K - $132K/yr
Responsibilities Job Title: Demonstration Specialist - US Reports to: Commercial Leader FLSA Status: Exempt Job Summary The Demonstration Specialist is responsible for showcasing and promoting ...
Demonstration Specialist
Somerville, MA · On-site +1
$120 - $130/hr
Job Summary The Demonstration Specialist is responsible for showcasing and promoting products and services through live demonstrations. The Demonstration Specialist, is a critical function for ...
Demonstration Specialist
Somerville, MA · On-site +1
$120 - $130/hr
Job Summary The Demonstration Specialist is responsible for showcasing and promoting products and services through live demonstrations. The Demonstration Specialist, is a critical function for ...
Deephealth information
What is DeepHealth?
What are the key skills and qualifications needed to thrive as a DeepHealth specialist?
How does a DeepHealth professional typically collaborate with clinicians and data scientists on healthcare projects?
What is the difference between Deephealth vs Data Scientist?
| Aspect | Deephealth | Data Scientist |
|---|---|---|
| Required Credentials | Typically requires a background in healthcare, machine learning, and programming skills | Requires a degree in computer science, statistics, or related fields; often includes certifications in data analysis or machine learning |
| Work Environment | Healthcare tech companies, hospitals, or research institutions focusing on medical data analysis | Varies across industries; tech firms, finance, healthcare, and consulting |
| Employer & Industry Usage | Primarily used in healthcare and medical AI applications | Widely used across multiple industries including tech, finance, healthcare, and marketing |
Deephealth specialists focus on applying AI and machine learning to healthcare data, often requiring medical knowledge and healthcare-specific skills. Data Scientists have a broader scope, working across various industries with skills in data analysis, programming, and statistical modeling. While both roles involve data analysis and machine learning, Deephealth roles are more specialized in healthcare applications.
What cities are hiring for Deephealth jobs?
Cities with the most Deephealth job openings:
What states have the most Deephealth jobs?
States with the most job openings for Deephealth jobs include:
What job categories do people searching Deephealth jobs look for?
The top searched job categories for Deephealth jobs are:

RadNet rating
6.5
Based on 169 frontline employees who took The Breakroom Quiz
569th of 891 rated healthcare providers
Job description
Job Title: Sr. Regulatory Affairs Specialist
Reports to: Quality and Regulation Leader
FLSA Status: Exempt
Job Summary
The Sr. Regulatory Affairs Specialist is responsible for supporting DeepHealth’s product and product development and regulatory activities
to commercialize new digital products, including AI technologies. In this role, the Sr. Regulatory Specialist will provide regulatory input
on design and development activities to cross-functional teams, to ensure compliance with the relevant regulatory requirements and
interactions with regulatory authorities.
Essential Duties and Responsibilities
As the Sr. Regulatory Affairs Specialist, this position will:
· Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices.· Assess the acceptability of documentation for medical device submissions and effectively communicate regulatory guidance.· Assist in SOP development and review in support of "next-gen" product offerings.· Revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.· Understand and investigate regulatory history/background of class, disease/ therapeutic context in order to assess regulatory implications for approval.· 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· Assist in preparation and review of regulatory submission to authorities.· Evaluate proposed design, labeling, and distribution changes for regulatory impact and implement any required regulatory action.· Utilize technical regulatory skills to propose strategies on complex issues.· Ensure compliance with product post marketing requirements.· Review product labeling to ensure compliance with relevant regulatory requirements.· Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees. Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel.- Work with the clinical teams to ensure compliance for pre- and post-market clinical studies in support of DeepHealth products and product changes.
- 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.
Minimum Qualifications, Education and Experience
Qualifications include:
- Bachelor’s degree in relevant field (or equivalent experience)
- 8 - 12 years working in a regulated industry (FDA and Software as a Medical Device preferred).
- Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820.
- Knowledge and experience drafting and submitting regulatory filings, including but not limited to, Q-Submission requests, and Traditional and Special 510(k) filings for Software as Medical Device.
- Experience with US FDA Class I and II medical devices. Additional experience with FDA Class III devices and OUS device classification a plus.
- Experience interacting with US and OUS Regulatory Authorities, including Q-Submission meetings, and product Deficiency Response meetings, and regulatory inspections.
- 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.
- Knowledge and understanding of Medical Devices Regulations (MDR 2017/745. MDCG 2019-11, MDCG 2020-1), ISO 13485, and MDSAP, ISO 14971, ISO 62366, IEC 82304-1, IEC 62304, preferred.
- 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.
Physical Demands
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).
Working Environment
Remote
Qualifications:UNAVAILABLEEducation:UNAVAILABLEEmployment Type: FULL_TIMEAbout RadNet
Sourced by ZipRecruiter
At RadNet, we are Leading Radiology Forward. RadNet aligns innovative solutions to deliver high-quality, cost-effective consumer-focused healthcare. Backed by 40 years of experience and with over 10,000 employees and over 380 imaging centers in 9 states, we are positioned for the future of healthcare.
Industry
Health care and social assistance
Company size
5,001 - 10,000 Employees
Headquarters location
Los Angeles, CA, US
Year founded
1980