Top 66542 Geography Jobs

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
COMMODITY SPECIALIST
Moses Lake Industries —Moses Lake, WA
- $65,000 - $88,400 a year
- Full-time
- Customer service
- Bachelor of Science
- English
- Health savings account
- AD&D insurance
Hiring Manager
Charleston Way —Houghton, MI
- $100,000 - $120,000 a year
- Full-time
- Background check
- Management
- Mid-level
- Paid training
- Health insurance
Quick Apply
Senior Metrologist
Industrial Inspection & Analysis —Minnetonka, MN
- $38 - $45 an hour
- 5 years
- High school diploma or GED
- Continuous improvement
- Paid holidays
- Disability insurance
Quick Apply
Senior Environmental Project Scientist
Trileaf Corporation —Schaumburg, IL
- $65,000 - $85,000 a year
- Full-time
- Microsoft Excel
- Computer literacy
- Mid-level
- Paid holidays
- Disability insurance
Quick Apply
12d
Apprentice Grower
Square Roots —Wyoming, MI
- $24.11 an hour
- Full-time
- Sanitation
- Cleaning
- 1 year
- Health insurance
- Dental insurance
Quick Apply
Scientific Quality Editor
Red Nucleus —Remote
- $67,000 - $78,000 a year
- Full-time
- Remote
- Doctor of Philosophy
- Communication skills
- Entry level
13d
Geography Adjunct Instructor
Glendale Community College —Glendale, CA
- $88.03 - $99.96 an hour
- Part-time
- Classroom
- Mid-level
- Master's degree
- Wellness program
- AD&D insurance
GIS Tech I
Energy Services Group, Inc. —Lakewood, CO
- Full-time
- Hybrid work
- Office
- Windows
- SQL
- Work from home
Jr. Geospatial Analyst - DHS
cFocus Software Incorporated —Remote
- Full-time
- Computer Science
- Mid-level
- 3 years
Quick Apply
GIS Specialist
Palm Beach County Supervisor of Elections —West Palm Beach, FL
- $72,800 - $87,000 a year
- Full-time
- Computer Science
- 5 years
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
Publication Manager I
Daiichi Sankyo —Basking Ridge, NJ
- $38 - $44 an hour
- Contract
- Remote
- Bachelor of Science
- Mid-level
- Bachelor's degree
- Dental insurance
- 401(k)
GIS Technician - ArcGIS
Denken Solutions, Inc. —Naperville, IL
- $45 an hour
- Monday to Friday
- Hybrid work
- Schematics
- Analysis skills
- Bachelor's degree
Quick Apply
Senior City Hall Reporter
Beacon Media Inc —Kansas City, MO
- $85,000 - $110,000 a year
- Full-time
- Hybrid work
- Research
- Senior level
- 10 years
- Paid parental leave
- Paid holidays
Quick Apply
Environmental Planner / Siting Specialist
The Ravin Group —Cincinnati, OH
- $80,000 - $150,000 a year
- Full-time
- Hybrid work
- Mid-level
- Office
- Driver's License
- AD&D insurance
- Relocation assistance
Quick Apply
GIS Analyst - 911 Liaison - Technology Services
Denton County, TX —Denton, TX
- $63,593 - $73,768 a year
- Full-time
- Computer Science
- HIPAA
- Research
- Wellness program
- Paid holidays
Color Scientist | Display & Image Quality Engineer
LG Electronics —Santa Clara, CA
- $150,000 - $200,000 a year
- Full-time
- 6 years
- Engineering
- Children
- Paid parental leave
- Paid holidays
Quick Apply
R&D Lab Engineer (Appliance Testing Lab)
LG Electronics —Buffalo Grove, IL
- $52,700 - $62,000 a year
- Full-time
- Engineering
- Mid-level
- Analysis skills
- Paid parental leave
- Paid holidays
Quick Apply
Mid Cartographic Analyst
Leidos —Springfield, VA
- $59,150 - $106,925 a year
- Full-time
- High school
- Bachelor of Science
- Mid-level
Junior Geographic Information Systems Analyst
Leidos —Orlando, FL
- $45,500 - $82,250 a year
- Full-time
- Bachelor's degree
- Quality control
- Fair chance

I want to receive the latest job alert for geography

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

geography jobs near

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

Regulatory Affairs Specialist

COMMODITY SPECIALIST

Hiring Manager

Senior Metrologist

Senior Environmental Project Scientist

Apprentice Grower

Scientific Quality Editor

Geography Adjunct Instructor

GIS Tech I

Jr. Geospatial Analyst - DHS

GIS Specialist

Publication Manager I

GIS Technician - ArcGIS

Senior City Hall Reporter

Environmental Planner / Siting Specialist

GIS Analyst - 911 Liaison - Technology Services

Color Scientist | Display & Image Quality Engineer

R&D Lab Engineer (Appliance Testing Lab)

Mid Cartographic Analyst

Junior Geographic Information Systems Analyst

I want to receive the latest job alert for geography

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected