Top 371 Regulatory specialist Jobs in Cleveland, Oh

Regulatory Affairs Specialist
CEDENT —Brecksville, OH
- Computer literacy
- Mid-level
- Criminal background check
Clinical Research Regulatory Specialist II, Seidman Cancer Center (Hybrid)
University Hospitals —Cleveland, OH
- $56,555 - $88,442 a year
- Computer literacy
- Mid-level
- Mentoring
Audit and Regulatory Specialist
Medical Service Company —Cleveland, OH
- $20.14 - $30.21 an hour
- Full-time
- Hybrid work
- Microsoft Word
- Mid-level
- Office
- Mileage reimbursement
- Health savings account
Quick Apply
Clinical Supervisor
Murtis Taylor Human Services System —Cleveland, OH
- $58,000 - $65,000 a year
- Weekends as needed
- LMFT
- Nursing
- Mid-level
- Health savings account
- Health insurance
Quick Apply
Compliance Specialist
Electronic Merchant Systems —Cleveland, OH
- From $18 an hour
- Full-time
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
- Health savings account
- Health insurance
Quick Apply
Sr. EHS Specialist
Ross Environmental Services, Inc. —Elyria, OH
- Microsoft Outlook
- Management
- 5 years
Quick Apply
Commercial Account Resolution Specialist
Weltman, Weinberg & Reis Co., LPA —Independence, OH
- $20.33 - $24.78 an hour
- Monday to Friday
- Background check
- Spanish
- Computer literacy
- Free parking
- Paid holidays
Quick Apply
Recertification Specialist - Euclid Beach
Fairstead ESC LLC —Cleveland, OH
- Mid-level
- Communication skills
- Paid holidays
- Disability insurance
Recertification Specialist - Euclid Beach
Fairstead ESC LLC —Richmond Heights, OH
- Mid-level
- Communication skills
- Paid holidays
- Disability insurance
Primary Care Physician
ChenMed —Cleveland, OH
- $221,141 - $315,915 a year
- Full-time
- Microsoft Outlook
- Primary Care
- English
- Opportunities for advancement
HVAC Territory Manager
Ferguson Enterprises, LLC —Valley View, OH
- $75,000 - $150,000 a year
- Full-time
- Residential
- Organizational skills
- Senior level
- Paid parental leave
- Health insurance
Field Technician – Fall Protection Systems
Diversified Fall Protection —Cleveland, OH
- $28 - $32 an hour
- Weekends as needed
- Background check
- Heavy lifting
- Construction site
- Disability insurance
- Health insurance
Quick Apply
Third Party Sr. Claims Representative
Fleet Response —Hudson, OH
- $22.00 - $22.50 an hour
- Full-time
- Research
- Analysis skills
- Math
- Disability insurance
- Health insurance
Quick Apply
Production Supervisor (PM Shift)
CIMA Plastics Group —Twinsburg, OH
- Overnight shift
- Basic math
- Mid-level
- Forklift
- Health insurance
- Dental insurance
Quick Apply
Primary Care Physician
ChenMed —Cleveland, OH
- $214,700 - $306,714 a year
- Full-time
- Medicine
- Microsoft Outlook
- BLS Certification
- Opportunities for advancement
Sales Support Specialist
Ferrotherm Corporation —Cleveland, OH
- $55,000 - $65,000 a year
- Full-time
- Background check
- Microsoft Excel
- Microsoft Outlook
- Health insurance
- Dental insurance
Quick Apply
Enterprise Testing Specialist Senior
PNC Financial Services Group —Cleveland, OH
- $63,750 - $106,250 a year
- Full-time
- Data analysis skills
- Office
- 3 years
- Wellness program
- Health savings account
Physician Leader Cleveland Ohio
HarmonyCares —Middleburg Heights, OH
- Full-time
- CPR Certification
- Clean driving record
- Medicine
- Paid training
- Paid holidays
9d
Part-Time Local Delivery Driver (Non-CDL)
Painters Supply and Equipment Co. —Middleburg Heights, OH
- Full-time
- Clean driving record
- Local
- Pass drug screening
- 401(k) matching
Quick Apply
2d
Compliance and Safety Specialist
Sonny's Enterprises LLC —Mentor, OH
- Bilingual
- Microsoft Word
- Bachelor of Science
- Disability insurance
- Health insurance

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Regulatory Affairs Specialist

CEDENT -
Brecksville, OH

Apply Now

Job Details

Qualifications

Desktop applications
Productivity software
Cross-functional collaboration
Associate's degree
Cross-functional communication

Full Job Description

This position is responsible for preparing submissions to various regulatory agencies. Additionally, the position will help maintain and improve upon domestic and international compliance. Candidate must possess the ability to work well in a team environment and demonstrate great attention to detail.

Duties and Responsibilities:
This list is not comprehensive but meant to represent the most common or important duties of the position. Other duties may be assigned.

Prepare and submit regulatory documentation, such as FDA 510(k) premarket notifications, to regulatory agencies, including FDA, Notified Bodies, and Authorized Representatives.
Prepare, maintain, and submit, when necessary, European Medical Device Directive and European Medical Device Regulation compliant Technical Files.
Create and/or modify regulatory procedures to remain in compliance with FDA, ISO, European, Canadian, and other standards.
Work with the international department on various regulatory filings for product registration in different countries.
Provides regulatory support for other projects as required.
Updating appropriate personnel on new and revised processes and procedures.
Process, execute, organize and archive various internal documentation related to Engineering and/or Quality Systems.
Preparing change order documentation and routing it for final approval.

Supervisory Responsibilities: None

Minimum Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience:

Minimum of 2 year college degree, Bachelor’s Degree (or greater) preferred.
Relevant work experience, preferably in the medical or legal field and/or other regulated industry.
Previous experience creating and revising labels and DFUs preferred.
Knowledge of European, ISO 13485 and FDA regulations preferred.
Knowledge of international regulatory guidelines regarding GMP requirements is desirable.

Language/Communication Skills:
Ability to communicate across functions, professional levels and background.

Computer Skills:
Intermediate to advanced knowledge of Microsoft Office Suite.

Essential Job Functions: Critical features of this job are described below. They may be subject to change at any time due to reasonable accommodation or other reasons.

Mental: Must be able to effectively communicate with others; complete and understand complex situations, analysis of numbers; read, analyze and interpret written materials; work with team to meet and exceed company standards; ensure compliance with company policies; respond appropriately to feedback to make improvements; maintain positive working relationships; troubleshoot and solve problems.

Physical: Must be able to communicate for hours at a time, use computer equipment. Moderate noise level and limited exposure to physical risk.

Knowledge, Skills, and Abilities Required: Knowledge of modern business communication, office procedures and methods. Skill to use a personal computer and various software packages such as Microsoft Office Suite. Ability to establish priorities, work independently with minimal supervision, and facilitate teamwork.

Equipment Used: Telephones, computer, other office equipment as needed.

Special/ Additional Requirements: Persons in this position may be required to pass a drug, alcohol, and/or criminal background check.

Apply Now

Refine Your Search

regulatory specialist jobs in cleveland, oh

Regulatory Affairs Specialist

Clinical Research Regulatory Specialist II, Seidman Cancer Center (Hybrid)

Audit and Regulatory Specialist

Clinical Supervisor

Compliance Specialist

Sr. EHS Specialist

Commercial Account Resolution Specialist

Recertification Specialist - Euclid Beach

Recertification Specialist - Euclid Beach

Primary Care Physician

HVAC Territory Manager

Field Technician – Fall Protection Systems

Third Party Sr. Claims Representative

Production Supervisor (PM Shift)

Primary Care Physician

Sales Support Specialist

Enterprise Testing Specialist Senior

Physician Leader Cleveland Ohio

Part-Time Local Delivery Driver (Non-CDL)

Compliance and Safety Specialist

I want to receive the latest job alert for regulatory specialist in cleveland, oh

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