Top 276 Technical integration specialist Jobs in Oklahoma City, Ok

Regulatory Affairs Specialist – FDA
IMMY —Norman, OK
- Full-time
- Remote
- Background check
- Mid-level
- Bachelor's degree
2d
Information Systems Applications Specialist II
Oklahoma Human Services —Oklahoma City, OK
- $80,000 a year
- Full-time
- Computer Science
- Mid-level
- Office
Quick Apply
8d
VFD Technical Support Specialist
ABB Inc. —Bethany, OK
- $52,500 - $84,000 a year
- Full-time
- Computer literacy
- English
- Mid-level
- Health savings account
- AD&D insurance
Quick Apply
4d
Multi-Media And Audio/Video Specialist
Norman Regional Health System —Norman, OK
- Computer Science
- Mid-level
- High school diploma or GED
Technical Product Support Specialist
SITECH —Oklahoma City, OK
- 5 years
- Mid-level
- Business development
- Dental insurance
- Vision insurance
Quick Apply
Vendor Management Specialist
Ted Moore Auto Group —Oklahoma City, OK
- Full-time
- Google Workspace
- Dealership
- Mid-level
5d
Configuration Management Specialist
Leidos —Oklahoma City, OK
- $116,350 - $210,325 a year
- Full-time
- Doctoral degree
- Bachelor of Science
- Master's degree
9d
Health Information Technology Specialist Central
IQVIA —Oklahoma City, OK
- $125,000 - $135,000 a year
- Full-time
- System design
- Mid-level
- Master's degree
End User Support Specialist - Shared Services Center
Bob Moore Auto Group —Oklahoma City, OK
- Mid-level
- Office
- 3 years
Applications Specialist I
SESCO Lighting Inc —Oklahoma City, OK
- Full-time
- Microsoft Outlook
- Mid-level
- Office
Quick Apply
12d
Technical Support Specialist
Navanta, LLC —Oklahoma City, OK
- $22.50 - $25.00 an hour
- Full-time
- Ability to sit for extended periods
- 1 year
- Ability to lift 25 pounds
Route Optimization Specialist
Baker Hughes —Oklahoma City, OK
- Full-time
- Mid-level
- Analysis skills
- Continuous improvement
- Health insurance
Information Systems Security Specialist
ASRC Federal —Norman, OK
- Full-time
- Computer Science
- Bachelor of Science
- Mid-level
- Paid holidays
- Health insurance
IT Specialist
ARL Bio Pharma —Oklahoma City, OK
- $26 - $32 an hour
- Full-time
- Research
- Mid-level
- Office
- 401(k) matching
- Food provided
Quick Apply
Remittance Processing Specialist I (Saturday & Sunday 6 AM-4:30 PM)
BOK Financial —Oklahoma City, OK
- HIPAA
- Office
- High school diploma or GED
IT Support Specialist - Catalyst Dental Allies
Catalyst Dental Allies —Edmond, OK
- Part-time
- Dental office
- Mid-level
- In-person
5d
IT Specialist
Skydweller US —Oklahoma City, OK
- Full-time
- Computer science
- Computer Science
- 5 years
- Health insurance
- Dental insurance
Quick Apply
Quality Assurance Specialist
The State of Oklahoma —Oklahoma County, OK
- Full-time
- Customer service
- Mid-level
- Office
Program Specialist (Part-Time/Year-Round) - City
City of Oklahoma City —Oklahoma City, OK
- $24 - $34 an hour
- Part-time
- Background check
- 18 years or older
- Pass drug screening
11d
Systems Support Specialist II - City
The City of Oklahoma City —Oklahoma City, OK
- $35.81 - $54.80 an hour
- Weekends as needed
- Background check
- Customer service
- Military
- Health insurance
- Opportunities for advancement
10d

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Regulatory Affairs Specialist – FDA

IMMY -
Norman, OK

Apply Now

Job Details

Full-time
2 days ago

Qualifications

Content creation for technical audiences
Process optimization
Technical documentation
ISO standards
Process improvement
Bachelor's degree
Biomedical regulatory compliance
Technical writing experience within technology

Full Job Description

This is a remote-eligible position, requiring the candidate live within the U.S.

Job Purpose

The Regulatory Affairs Specialist – FDA is responsible for preparing and maintaining U.S. FDA regulatory submissions for IMMY's in vitro diagnostic products, and for securing and maintaining the clearances, registrations, listings, and licenses required to place and keep those products on the U.S. market.

Key duties and responsibilities

Bring New Products to the U.S. Market

Determine the appropriate U.S. regulatory pathway for IMMY’s products, including classification, product code selection, and predicate identification
Prepare and submit 510(k), PMA, De Novo, and Emergency Use Authorization submissions (as applicable), along with the technical documentation supporting each marketing authorization
Manage Q-Submissions and other formal interactions with FDA review divisions, including tracking review timelines and responding to Agency requests
Advise product development teams on FDA expectations for analytical and clinical performance data, including verification and validation study design

Keep Products Registered and Available

Monitor the U.S. regulatory status of the marketed portfolio on an ongoing basis to confirm that each product remains lawfully marketable, and identify and remediate any lapse or other issues with existing registrations, listings, licenses, or authorization.
Maintain establishment registration, device listing, UDI/GUDID data, and other institutional and/or product registrations related to U.S. market access.
Support post-market activities for marketed products, including reportability assessments, Medical Device Reports, field actions, and reports of corrections and removals

Maintain U.S. Regulatory Compliance

Review labeling, package inserts, instructions for use, and other materials for compliance with applicable regulations
Verify that promotional, marketing, and sales-facing materials remain consistent with the cleared or authorized intended use
Maintain regulatory records, submission files, FDA correspondence, and other data and files inspection-ready for audit by FDA or other regulatory authorities or authorized third parties
Comply with, and assist IMMY in complying with, all applicable FDA medical device regulatory requirements, applicable ISO 13485 requirements, and all other applicable laws, regulations, and standards
Monitor and assess the operational impact of regulatory changes affecting IMMY’s processes and products available in the U.S., ensuring timely planning and implementation of any changes necessary for compliance

Qualifications

Required:

Bachelor’s degree in related discipline and 2+ years of experience performing Regulatory Affairs support activities in a U.S. FDA regulated environment
Broad knowledge of U.S. FDA medical device regulations and their application to IVDs
Broad knowledge of ISO 13485 standards requirements
Effective technical writing and oral communication skills
Extremely organized with high attention to detail
Effective at multi-tasking
Ability to work in a fast-paced, timeline-driven environment
Ability to work independently and as part of a team
Ability to organize information so that it is easily understood and reviewed, both internally and externally
Ability to identify ways to improve/simplify processes

Equal Opportunity Employment: IMMY is committed to the principle of equal employment opportunity for 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. IMMY will not tolerate discrimination or harassment based on any of these characteristics. This policy applies to all terms and conditions of employment, including, but not limited to, recruiting, hiring, promotion, termination, leaves of absence, compensation, and training.

Background Check Policy: All offers of employment at IMMY are contingent upon clear, acceptable results of a thorough background check. IMMY performs all background checks in compliance with EEOC and FCRA regulations and all other applicable federal, state, and local laws.

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Refine Your Search

technical integration specialist jobs in oklahoma city, ok

Regulatory Affairs Specialist – FDA

Information Systems Applications Specialist II

VFD Technical Support Specialist

Multi-Media And Audio/Video Specialist

Technical Product Support Specialist

Vendor Management Specialist

Configuration Management Specialist

Health Information Technology Specialist Central

End User Support Specialist - Shared Services Center

Applications Specialist I

Technical Support Specialist

Route Optimization Specialist

Information Systems Security Specialist

IT Specialist

Remittance Processing Specialist I (Saturday & Sunday 6 AM-4:30 PM)

IT Support Specialist - Catalyst Dental Allies

IT Specialist

Quality Assurance Specialist

Program Specialist (Part-Time/Year-Round) - City

Systems Support Specialist II - City

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