Top 53228 Documentation specialist 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
Export Documentation Specialist
Agile Cold Storage —Joliet, IL
- From $19 an hour
- Full-time
- Quality control
- In-person
- Communication skills
- Paid time off
- Employee discount
Quick Apply
Document Control Specialist
M2 Integration LLC —Estacada, OR
- $25 - $27 an hour
- Full-time
- Background check
- Microsoft Excel
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
10d
Document Quality Specialist
Alvah Contracting, LLC —South San Francisco, CA
- $33 - $36 an hour
- Full-time
- Hybrid work
- Microsoft Excel
- Microsoft Outlook
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
8d
Engineering Documentation Specialist
C.E. NIEHOFF & Co. —Chicago, IL
- $20 - $60 an hour
- Full-time
- Microsoft Word
- Background check
- Microsoft Excel
- Paid holidays
- Disability insurance
Quick Apply
Clinical Documentation Specialist
City of Hope —Remote
- $45.20 - $63.29 an hour
- Full-time
- Nursing
- RN License
- Mid-level
10d
Regulatory Operations Documentation Specialist
Shionogi Inc. —Florham Park, NJ
- $40 - $57 an hour
- Email
- Remote
- Microsoft Word
- Quality control
- Organizational skills
Clinical Documentation Specialist
Managed Resources, Inc (MRI) —Remote
- $32 - $45 an hour
- Full-time
- Remote
- Anatomy knowledge
- RN License
- Mid-level
- Paid holidays
- Health insurance
8d
Outpatient Clinical Documentation Specialist
Boston Medical Center —Remote
- $27.88 - $40.38 an hour
- Full-time
- Remote
- Nursing
- 5 years
- Computer literacy
- Health insurance
- Dental insurance
Document Control Analyst/ Labeling Specialist
Experis —Carlsbad, CA
- $25 an hour
- Contract
- Mid-level
- Organizational skills
- Communication skills
- Health savings account
- Disability insurance
Quick Apply
2d
Clinical Documentation Specialist-Remote
Onpoint Healthcare —Remote
- $45 - $55 an hour
- Full-time
- Remote
- RN License
- Hospital
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
2d
Documentation Control Specialist
Advantage Technical —Beverly, MA
- $60,000 - $65,000 a year
- Full-time
- Mid-level
- Continuous improvement
- Communication skills
- Paid holidays
- Disability insurance
Quick Apply
Documentation Specialist - NE Florida
Pinnacle Home Care —Jacksonville, FL
- Remote
- HIPAA
- Mid-level
- Microsoft Office
- Health insurance
- Referral program
Quick Apply
Compliance Support Specialist
TRES HEALTH INC —Remote
- Remote
- Research
- Mid-level
- Office
Agency Data Specialist I
LERETA, LLC —Pomona, CA
- $39,056 - $68,640 a year
- Remote
- Microsoft Outlook
- Word processing
- High school diploma or GED
Quick Apply
Clinical Documentation Specialist Audit Coordinator (Remote)
Trinity Health —Livonia, MI
- $41.43 - $62.15 an hour
- Full-time
- Remote
- RN License
- Mid-level
- Databases
Electronic Record Specialist - Remote
Sheboygan County —Plymouth, WI
- $26.02 - $27.84 an hour
- Full-time
- Remote
- Senior level
Chart Integrity Specialist
Lee Health —Cape Coral, FL
- $20.04 - $25.05 an hour
- Full-time
- Remote
- Mid-level
Documentation & End User Training Specialist
Hamilton College —Remote
- $65,000 - $75,000 a year
- Full-time
- Google Workspace
- Microsoft Excel
- Mid-level
10d
Technical Writer - 508 Documentation Specialist
General Dynamics Information Technology —Remote
- $74,800 - $101,200 a year
- Remote
- Microsoft Word
- Microsoft Excel
- Oracle
- Paid holidays
- 401(k) matching
5d

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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

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documentation specialist jobs

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