Top 3812 Knowledge management specialist Jobs in New York Ny

Regulatory Affairs Specialist
elliquence, LLC —Baldwin, NY
- $75,000 - $85,000 a year
- Full-time
- Background check
- Mid-level
- Office
- Health insurance
- Dental insurance
Quick Apply
Digital Content Specialist/Developer
United Federation of Teachers —New York, NY
- $70,000 - $80,000 a year
- Weekends as needed
- Office
- Bachelor's degree
- Children
- Health insurance
- Dental insurance
Quick Apply
Training Specialist - Manhattan
COORDINATED CARE ALLIANCE NY INC —New York, NY
- $30.00 - $32.35 an hour
- Full-time
- Classroom
- Microsoft Excel
- Microsoft Outlook
Quick Apply
11d
Community Support Specialist
RfoodX LLC —Bronx, NY
- $85,000 - $95,000 a year
- Full-time
- Background check
- Microsoft Excel
- Microsoft Outlook
- Mileage reimbursement
- Disability insurance
Quick Apply
Account Management Specialist
Macy’s —New York, NY
- $81,120 - $135,120 a year
- Writing skills
- Mid-level
- 3 years
- Store discount
- Paid holidays
Identity & Access Management Specialist
Milbank LLP —New York, NY
- $140,000 - $160,000 a year
- Full-time
- Remote
- Computer Science
- 5 years
- Bachelor's degree
Brand Management Specialist
McDermott Will & Emery —New York, NY
- $102,000 - $136,000 a year
- Full-time
- Merchandising
- Mid-level
- Office
Lead Compliance Specialist, Medicaid - Remote
EmblemHealth —New York, NY
- $77,760 - $149,040 a year
- Remote
- Microsoft Excel
- Microsoft Outlook
- 5 years
Expedited Appeals Specialist (Remote)
EmblemHealth —New York, NY
- $48,600 - $83,160 a year
- Weekends as needed
- Remote
- Microsoft Outlook
- Research
- Mid-level
6d
Knowledge Enablement Specialist - Vice President
JPMorganChase —New York, NY
- $142,500 - $190,000 a year
- Full-time
- Bachelor of Science
- Bachelor's degree
- Machine learning
- Health insurance
- Tuition reimbursement
Client Success Specialist II
Affirm —New York, NY
- $100,000 - $137,500 a year
- Remote
- Mid-level
- Bachelor's degree
- Fair chance
- Employee stock purchase plan
- Health insurance
Specialist, Product Management - Crypto Flows
Mastercard —New York, NY
- $100,000 - $164,000 a year
- Online Application
- Mid-level
- Analysis skills
- Product management
- Paid jury duty
- Health savings account
10d
Control Management Specialist
Bloomberg —New York, NY
- $190,000 - $240,000 a year
- Finance
- 8 years
- Analysis skills
- Paid holidays
- Disability insurance
AI Enablement Specialist
Kyndryl —New York, NY
- $100,080 - $228,000 a year
- Full-time
- Remote
- Mid-level
- Bachelor's degree
- SharePoint
- Health insurance
- Dental insurance
12d
Lead Audit Specialist - Remote
EmblemHealth —New York, NY
- $77,760 - $149,040 a year
- Remote
- Microsoft Excel
- Microsoft Outlook
- 5 years
Provider File Specialist - Remote
EmblemHealth —New York, NY
- $48,600 - $83,160 a year
- Remote
- Microsoft Outlook
- Research
- Mid-level
10d
Senior Training Specialist
EmblemHealth —New York, NY
- $56,160 - $99,360 a year
- Classroom
- Microsoft Outlook
- Customer service
Onboarding Specialist
NYC Health + Hospitals —New York, NY
- $60,000 - $70,000 a year
- Online Application
- Google Workspace
- Hospital
- Customer service
- Commuter assistance
- Paid holidays
Admissions Specialist
Odyssey House INC —New York, NY
- $24.73 - $30.22 an hour
- Psychiatry
- High school diploma or GED
- Rehabilitation center
- Commuter assistance
- Disability insurance
Quick Apply
Change Management Specialist
Barnard College —New York, NY
- $115,000 - $120,000 a year
- Full-time
- Hybrid work
- Google Workspace
- 5 years
- Office

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knowledge management specialist jobs near new york ny

Regulatory Affairs Specialist

elliquence, LLC -
Baldwin, NY

Quick Apply

Job Details

Full-time
$75,000 - $85,000 a year

Benefits

Health insurance
Dental insurance
401(k)
Paid time off
Vision insurance

Qualifications

Medical device validation
Regulatory Affairs Certification (RAC)
Process improvement standards implementation
Regulatory compliance
Biomedical Engineering
Bachelor's degree
Health Science
Regulatory affairs
Biomedical regulatory compliance
Manufacturing

Full Job Description

About the job
This role collaborates cross-functionally with Quality, Engineering, Clinical, and Manufacturing teams to prepare, submit, and maintain regulatory filings with agencies such as the U.S. FDA, European Notified Bodies, and other international authorities.

Key Responsibilities:
Primary Responsibilities

Assist in the preparation, formatting, and collection of regulatory submissions
Ensure the maintenance of regulatory files, declarations of conformity, and device listings/registrations are accurate and complete.
Oversee inquiries into regulatory agency requests for additional information for document submission.
Support U.S. and EU market approval processes and ensure compliance with regulatory standards
Support post-market submissions (progress reports, annual reports, etc.)
Provide regulatory assessments for marketing, R&D, and manufacturing changes or product transfers.
Communicate with distributors in response to requests for information, regulatory inquiries or in support of regulatory filings.

Compliance & Quality System Support

Partner with Quality Assurance to ensure continued compliance with applicable regulatory standards, including FDA 21 CFR 820, ISO 13485, and EU MDR 2017/745.
Support in audits (internal and external) in document preparation as needed.
Support document control and recordkeeping to ensure regulatory documentation integrity and traceability.
Assist in preparing regulatory applications that are compliant with applicable regulatory requirements to achieve business objectives.

Cross-Functional Collaboration

Partner with Engineering and Clinical teams to gather information needed for submissions and documentation.
Assist in preparing summaries, tracking deliverables, and ensuring timely submission of regulatory documents.
Support training and awareness initiatives related to regulatory compliance.
Interpret new or existing regulations and ensure business practices align with compliance requirements.
Create documentation in response to customer regulatory requests which includes regulatory letters, authorization letters, certifications, attestations, technical packages, etc. for tenders and for pre-market clearance.
Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to other teams/departments and executive leadership.
Establish and maintain regulatory information systems.
Contribute in continuous improvement initiatives and process optimization within Regulatory Affairs.

Qualifications:

Bachelor's degree in biomedical, RA/QA or related scientific area for medical device industry (RAC certification preferred).
Master’s degree in related field can count towards 1 year of relevant experience.
3-5 years of experience in a regulated FDA environment (medical devices or combination products).
Hands-on experience with 510(k) submissions (IDE and PMA knowledge a plus). Strong knowledge in regulatory strategy and approval approaches.
Strong understanding of FDA and EU medical device regulations (international experience desirable).
Working knowledge of FDA, EU MDR, or ISO regulatory environments preferred.
Audit experience as a contributor is preferred.
Ability to efficiently navigate through the regulatory process either individually or in a team setting ensuring a project’s success.
Strong organizational, communication (verbal and written), and planning skills.
Ability to interact cross functionally across multiple departments with various levels of the organization.
Detail oriented, practical and proactive problem solver.
Proficiency with PC systems and office applications.
Solid understanding of scientific principles applied to regulatory affairs.
Understanding of regulatory and business needs with ability to engage cross functional team members.

Salary range is $75,000- $85,000/annual USD

An employment offer is based on the candidate's professional experience, specialty, skillset, education, geography, related licenses or certifications, and other business needs. The compensation range indicated does not include other forms of compensation or benefits.
We value the diversity of our team and inspire creativity in our innovation. elliquence proudly provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state and local laws.
We are committed to working with and providing reasonable accommodation to individuals with disabilities. If you need any reasonable accommodation due to a disability for any part of the application process, please email [email protected].

Job Type: Full-time

Pay: $75,000.00 - $85,000.00 per year

Benefits:

401(k)
Dental insurance
Health insurance
Paid time off
Vision insurance

Ability to Commute:

Baldwin, NY 11510 (Required)

Ability to Relocate:

Baldwin, NY 11510: Relocate before starting work (Required)

Work Location: In person

Quick Apply

Refine Your Search

knowledge management specialist jobs in new york ny

Regulatory Affairs Specialist

Digital Content Specialist/Developer

Training Specialist - Manhattan

Community Support Specialist

Account Management Specialist

Identity & Access Management Specialist

Brand Management Specialist

Lead Compliance Specialist, Medicaid - Remote

Expedited Appeals Specialist (Remote)

Knowledge Enablement Specialist - Vice President

Client Success Specialist II

Specialist, Product Management - Crypto Flows

Control Management Specialist

AI Enablement Specialist

Lead Audit Specialist - Remote

Provider File Specialist - Remote

Senior Training Specialist

Onboarding Specialist

Admissions Specialist

Change Management Specialist

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