Top 1503 Technical specialist Jobs in Brooklyn 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
Mobile Repair & Sales Expert – On-the-Road Experienced PhoneTechnician
uBreakiFix by Asurion —Brooklyn, NY
- $18 - $22 an hour
- Overtime
- Sales
- No background check
- English
- Employee discount
- Professional development assistance
Quick Apply
SAP Support Specialist
Advantage Technical —Paramus, NJ
- $80,000 - $105,000 a year
- Full-time
- Computer science
- Computer Science
- Mid-level
- Paid holidays
- Health insurance
Quick Apply
Housing Program Specialist
Urban Upbound —Long Island City, NY
- $50,000 - $60,000 a year
- Weekends as needed
- Microsoft Word
- Spanish
- Microsoft Excel
- Health insurance
- Dental insurance
Quick Apply
Clinical Professional Development Educator
Northwell Health —New York, NY
- $105,400 - $183,000 a year
- Per diem
- Nursing
- RN License
- Master's degree
Online Chat Specialist (Entry Level)
Life Church Victorvillle —New York, NY
- $28 - $35 an hour
- Full-time
- Remote
- Communication skills
- Entry level
6d
Assistive Technology Specialist
New York University —New York, NY
- $70,000 - $77,000 a year
- Full-time
- Hybrid work
- Working with individuals with disabilities
- Writing skills
- Mid-level
IT Support Professional
All Heart Home Care Inc. —Brooklyn, NY
- $55,000 - $75,000 a year
- Full-time
- Mid-level
- Office
- Windows
- Commuter assistance
- Health insurance
Quick Apply
Facilitated Enrollment Specialist
MetroPlusHealth —Brooklyn, NY
- $60,000 a year
- Weekends as needed
- Public speaking
- Mid-level
- 3 years
- Health insurance
Quick Apply
Training & Development Specialist
Transitional Services For New York Inc —Queens, NY
- $75,000 a year
- Full-time
- Microsoft Outlook
- Writing skills
- Mid-level
- Dental insurance
- Vision insurance
Quick Apply
IT Support Specialist I
Weill Cornell Medicine —New York, NY
- $33.30 - $37.69 an hour
- Weekends as needed
- Mid-level
- Windows
- High school diploma or GED
Customer Support Specialist
1stdibs.com —New York, NY
- $24.50 - $27.00 an hour
- Remote
- Spanish
- 1 year
- Communication skills
- Commuter assistance
- Paid parental leave
Quick Apply
IT Specialist – Operations & Support
Diamond Braces —Brooklyn, NY
- $65,000 a year
- Computer science
- Computer Science
- Windows
- Paid holidays
- Health insurance
Quick Apply
Computer Specialist (Software) Level 1-4 (TWU)
Metropolitan Transportation Authority —New York, NY
- $109,076 - $158,514 a year
- Full-time
- Computer science
- Azure
- Computer Science
Technical Implementation Specialist
Northbeam —New York, NY
- $140,000 - $165,000 a year
- 8 hour shift
- Remote
- Mid-level
- Communication skills
- Paid parental leave
- Paid holidays
Quick Apply
Associate Medical Records Specialist
NYC Health + Hospitals —New York, NY
- $72,615 a year
- Online Application
- Hospital
- Mid-level
- High school diploma or GED
- Commuter assistance
- Paid holidays
Senior IT & Event Technology Specialist
Fanatics Inc. —New York, NY
- $100,000 - $130,000 a year
- Weekends as needed
- Microsoft Outlook
- 5 years
- Office
Quick Apply
Automation Support Specialist
New York Eastern Probation Office —Brooklyn, NY
- $58,169 - $94,588 a year
- Computer Science
- Mid-level
- Office
- Paid holidays
- Health insurance
Product Support Specialist
Anthropic —New York, NY
- $131,040 - $210,000 a year
- On call
- Hybrid work
- Mid-level
- Office
- SQL
- Parental leave
- Flexible schedule
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

I want to receive the latest job alert for technical specialist in brooklyn ny

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

technical specialist jobs near brooklyn 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

technical specialist jobs in brooklyn ny

Regulatory Affairs Specialist

Mobile Repair & Sales Expert – On-the-Road Experienced PhoneTechnician

SAP Support Specialist

Housing Program Specialist

Clinical Professional Development Educator

Online Chat Specialist (Entry Level)

Assistive Technology Specialist

IT Support Professional

Facilitated Enrollment Specialist

Training & Development Specialist

IT Support Specialist I

Customer Support Specialist

IT Specialist – Operations & Support

Computer Specialist (Software) Level 1-4 (TWU)

Technical Implementation Specialist

Associate Medical Records Specialist

Senior IT & Event Technology Specialist

Automation Support Specialist

Product Support Specialist

Onboarding Specialist

I want to receive the latest job alert for technical specialist in brooklyn ny

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected