Top 3163 Geography 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
High School History Teacher
Uncommon New York City Charter Schools —New York, NY
- $72,000 - $115,000 a year
- Full-time
- Classroom
- High school
- Mid-level
- 403(b) matching
- Health savings account
Quick Apply
Member Relations Director
Confluence Philanthropy —Manhattan, NY
- $104,000 - $114,000 a year
- Email
- Hybrid work
- Research
- Mid-level
- Office
Quick Apply
HCP Sales Representative, Dermatology
Advantice Health LLC —New York State
- $100,000 - $125,000 a year
- 5 years
- Travel
- Senior level
Context Engineer - Manager - Consulting - Location OPEN
EY —New York, NY
- $125,500 - $261,600 a year
- Azure
- System design
- Research
- Paid holidays
- Health insurance
Assistant Video Editor (Project-Based)
Employment Opportunities at BuzzFeed, Inc. —New York, NY
- $250 a day
- Mid-level
- 3 years
- Quality control
Quick Apply
Subsidiary Rights Assistant, Children's Publishing
Simon & Schuster —New York, NY
- $50,000 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- Computer literacy
- Health insurance
- Dental insurance
Quick Apply
Camera Operator (Project-Based)
Employment Opportunities at BuzzFeed, Inc. —New York, NY
- $350 a day
- Mid-level
- Office
- Communication skills
Quick Apply
Assistant Digital Merchandiser, Womens and Kids
Tommy Hilfiger —New York, NY
- $60,800 - $87,800 a year
- Full-time
- Hybrid work
- Salesforce
- Merchandising
- Research
- Paid holidays
- Disability insurance
Clinical Intelligence
Forus —New York, NY
- $120,000 - $240,000 a year
- Full-time
- Medicine
- Office
- Outpatient experience
- Commuter assistance
- Health insurance
Administrative Relationship Manager Assistant Director - NYC
EY —New York, NY
- $91,900 - $195,200 a year
- Mid-level
- Microsoft Office
- 8 years
- Paid holidays
- Health insurance
Embodied AI Researcher (R&D Lab)
LG Electronics —New York, NY
- $150,000 - $210,000 a year
- Full-time
- Hybrid work
- Computer Science
- Doctor of Philosophy
- Children
- Paid parental leave
- Paid holidays
Quick Apply
Proximo - 1800 Head of Brand Advocacy
GMR Marketing (In-Market) —New York, NY
- $135,000 - $150,000 a year
- Senior level
- Communication skills
- Commercial
Quick Apply
Urgent Care Account Specialist
Inizio Engage —New York, NY
- $88,000 - $163,000 a year
- Full-time
- Background check
- 5 years
- Urgent Care
- Paid parental leave
- Paid holidays
Pharmaceutical Field Sales Representative
Inizio Engage —Queens, NY
- $60,000 - $111,000 a year
- Full-time
- Background check
- Mid-level
- Pediatrics
- Paid parental leave
- Paid holidays
6d
Pharmaceutical Field Sales Representative
Inizio Engage —Brooklyn, NY
- $60,000 - $111,000 a year
- Full-time
- Background check
- Mid-level
- Pediatrics
- Paid parental leave
- Paid holidays
6d
Data Manager (Non Profit & Health Equity)
Vaco by Highspring —New York, NY
- $40 - $45 an hour
- SQL
- In-person
- Senior level
Quick Apply
6d
Associate Producer
Newsmax —New York, NY
- $63,000 - $72,000 a year
- Overnight shift
- Research
- Mid-level
- 3 years
- Paid holidays
- Dental insurance
Quick Apply
Deal Desk Analyst
LiveRamp —New York, NY
- $78,500 - $111,500 a year
- Full-time
- Bachelor of Science
- ERP systems
- Public speaking
- Paid parental leave
- Paid holidays
Graphics Editor
Guardian News & Media —New York, NY
- $130,000 - $140,000 a year
- Full-time
- Hybrid work
- Management
- Senior level
- Commercial
- Commuter assistance
- Disability insurance
7d

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geography 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

geography jobs in new york, ny

Regulatory Affairs Specialist

High School History Teacher

Member Relations Director

HCP Sales Representative, Dermatology

Context Engineer - Manager - Consulting - Location OPEN

Assistant Video Editor (Project-Based)

Subsidiary Rights Assistant, Children's Publishing

Camera Operator (Project-Based)

Assistant Digital Merchandiser, Womens and Kids

Clinical Intelligence

Administrative Relationship Manager Assistant Director - NYC

Embodied AI Researcher (R&D Lab)

Proximo - 1800 Head of Brand Advocacy

Urgent Care Account Specialist

Pharmaceutical Field Sales Representative

Pharmaceutical Field Sales Representative

Data Manager (Non Profit & Health Equity)

Associate Producer

Deal Desk Analyst

Graphics Editor

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