Top 1270 Regulatory project manager Jobs in Orange, Ca

Project Manager, Regulatory Affairs
JENAVALVE TECHNOLOGY INC —Irvine, CA
- $130,000 - $140,000 a year
- Full-time
- Remote
- 5 years
- Project management
- Travel
Quick Apply
2d
Pipeliner Entry - Orange
Kinder Morgan —Orange, CA
- $33 - $47 an hour
- Extended hours
- Background check
- Microsoft Excel
- Microsoft Outlook
- Paid parental leave
- Paid holidays
7d
Principal Engineering Lead
SSA Marine, Inc —Long Beach, CA
- $200,000 - $250,000 a year
- Full-time
- Hybrid work
- Spanish
- Civil engineering
- Engineering
- Paid jury duty
- Paid parental leave
Quick Apply
Proposal Administrator
EEC Environmental —Orange, CA
- $90,000 - $110,000 a year
- Full-time
- Microsoft Excel
- Marketing
- 5 years
- Profit sharing
- Paid holidays
12d
Supervisor, Procurement - IT Procurement
Inland Empire Health Plan —California
- $104,041.60 - $137,841.60 a year
- Full-time
- Hybrid work
- Office
- High school diploma or GED
- Supervising experience
- Disability insurance
- Health insurance
Game Product Manager (Chinese Mandarin Speaker)
Bitus Labs —Irvine, CA
- From $100,000 a year
- Full-time
- English
- Mid-level
- Office
- Health insurance
- Dental insurance
Quick Apply
Senior Import Logistics Operations /Customer Services
TOPASIA INTERNATIONAL LOGISTICS US. CO.,LTD —West Covina, CA
- From $60,000 a year
- Full-time
- Customer service
- English
- Mid-level
- Paid holidays
- Health insurance
Quick Apply
Public Works Labor Compliance Specialist
Confidential —Orange, CA
- From $25 an hour
- Full-time
- Mid-level
- 3 years
- Analysis skills
- Paid time off
- Flexible schedule
Quick Apply
Director of Fabrication
AKJOHNSTON Group LLC —Anaheim, CA
- $120,000 - $140,000 a year
- Full-time
- Microsoft Outlook
- Forklift
- High school diploma or GED
- Health insurance
- Dental insurance
Quick Apply
2d
Facilities and EHS Manager
Calnetix Technologies, LLC —Cypress, CA
- $160,000 - $190,000 a year
- Full-time
- Office
- Ability to climb stairs
- Bachelor's degree
Quick Apply
Healthcare Facility Manager
Infusion For Health —Anaheim, CA
- $60,000 - $85,000 a year
- Full-time
- Hybrid work
- Up to 50% travel
- Mid-level
- 3 years
- Health insurance
- Dental insurance
Quick Apply
2d
Special Projects Manager
San Gabriel Transit, Inc. —El Monte, CA
- From $110,000 a year
- Full-time
- Background check
- Spanish
- Clean driving record
- Health insurance
- 401(k)
Quick Apply
6d
Accounting Manager (Bilingual in Korean)
Cesna Recruitment —Irvine, CA
- Full-time
- Hospitality
- English
- 3 years
- Health insurance
- Dental insurance
Quick Apply
Call Center Manager (Healthcare)
Infusion For Health —Brea, CA
- $85,000 - $100,000 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- HIPAA
- Health insurance
- Dental insurance
Quick Apply
VP, Operational Risk Business Partner - Risk Management
Cathay Bank —El Monte, CA
- $110,000 - $133,000 a year
- Full-time
- 5 years
- Office
- Finance
- Health savings account
- Disability insurance
Quick Apply
OSP Construction Manager - Orange County, CA
Swoon Group —Orange County, CA
- $100,000 - $120,000 a year
- Full-time
- Construction site
- Engineering
- Driver's License
- Health insurance
- Dental insurance
Quick Apply
6d
VP, Sr. Loan Review Officer / VP, Loan Review Officer
Cathay Bank —El Monte, CA
- $114,800 - $177,500 a year
- Full-time
- Microsoft Excel
- 5 years
- Office
- Health savings account
- Disability insurance
Quick Apply
Paralegal, Regulatory Compliance
KabaFusion —Cerritos, CA
- $33.65 - $41.14 an hour
- Full-time
- Microsoft Word
- Writing skills
- Research
- Paid holidays
- Disability insurance
Quick Apply
Treasury Management Implementation & Support Operations Officer (NE)
Cathay Bank —El Monte, CA
- $58,300 - $62,100 a year
- Full-time
- 5 years
- ERP systems
- Mid-level
- Health savings account
- Disability insurance
Quick Apply
Water Treatment Design Lead
Ardurra Group, Inc. —Irvine, CA
- $140,000 - $200,000 a year
- Hybrid work
- Office
- Master's degree
- 8 years
Quick Apply

I want to receive the latest job alert for regulatory project manager in orange, ca

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

regulatory project manager jobs near orange, ca

Water Treatment Specialist jobs in Irvine, CA

Accounting Manager jobs in Irvine, CA

Construction Manager jobs in Orange County, CA

Fabricator jobs in Anaheim, CA

Compliance Officer jobs in Orange, CA

Loan Officer jobs in El Monte, CA

Regulatory Affairs Specialist jobs in Irvine, CA

Paralegal jobs in Cerritos, CA

Operations Officer jobs in El Monte, CA

Supply Chain Specialist jobs in California

Environmental Health And Safety Manager jobs in Dallas Fort Worth, TX

Safety Manager jobs in Columbus, OH

Environmental Health And Safety Manager jobs in Horn Lake, MS

Environmental Health And Safety Manager jobs in Poughkeepsie, NY

Program Manager Healthcare jobs in Chicago, IL

Environmental Health And Safety Manager jobs in Palmyra, WI

Water Treatment jobs in Alabama

Water Treatment Specialist jobs in Sunrise, FL

Water Treatment Plant Operator jobs in Florida

Water Treatment jobs in San Diego, CA

Project Manager, Regulatory Affairs

JENAVALVE TECHNOLOGY INC -
Irvine, CA

Quick Apply

Job Details

Full-time
$130,000 - $140,000 a year
2 days ago

Qualifications

Content creation for technical audiences
Technical documentation
Project management
Cultural competency
Task prioritization
Biomedical regulatory compliance
Productivity software
Quality systems
Technical writing experience within technology

Full Job Description

Job Title: Project Manager, Regulatory Affairs

Supervisor/Manager Title: Senior Manager, Regulatory Affairs

Job Location & Environment: Remote

Job Description Summary: Responsible for timely preparation and submission of organized, scientifically valid global regulatory affairs submissions (clinical, pre-, and post-market applications), query responses and correspondence tracking. Maintains regulatory information for competitive intelligence, literature maintenance, and standards review programs. Interacts with internal departments and external representatives (i.e., distributors, legal agents, regulatory agencies). Provides expertise in translating regulatory requirements into practical, workable strategy and planning documents. Provides counsel to project team members and regulatory affairs staff as applicable. Supports serious adverse event reporting, and completion of post-market surveillance activities (complaints, MDR and vigilance reports). Performs other projects and duties as assigned.

Job Responsibilities:

Prepare timely, high-quality, technical documentation and regulatory submissions for investigational device applications, commercial registrations, annual reports, and amendments/supplements.
Serve as a regulatory team member of product development and sustaining teams, providing clear, concise regulatory strategy to ensure applicable global requirements are met for product development and quality system projects.
Collaborate with key stakeholders to develop technical, clinical, or labeling content (including Clinical Operations, Marketing, R&D, Manufacturing and Quality) to support company objectives and regulatory submissions.
Provide coaching and support to other members of the regulatory department.
Communicate with regulatory bodies, legal agents, distributor partners, and suppliers on project-related activities necessary to ensure appropriate regulatory approvals are in place in covered regions.
Review document change orders for impact on US, EU and international regulatory filings per standard procedures.
Manage standards review process and assist company SME’s to interpret existing or new regulatory requirements for company products and procedures, labeling, marketing projects, clinical studies, testing, and record keeping.
Support serious adverse event reporting process, Medical Device Reports (MDRs), Vigilance reports, field safety notices, and other communication with regulatory authorities and external stakeholders.
Review and approve FMEAs/risk analyses, protocols, reports, NCRs, CAPAs, and other technical documents.
Participate in internal audits and external audits as needed.
Update and maintain departmental procedures as required.
Perform other duties as assigned.

Required Education and Experience:

Bachelor’s degree in a scientific discipline (engineering, biology, etc.) or equivalent is required.
Minimum of 5 to 8 years in medical device Regulatory Affairs.
Experience with US Class III cardiovascular devices preferred.
Experience with EU MDR implementation preferred.
Comprehensive knowledge of quality systems and relationship to business.
Experience in applying global medical device regulations and product development process.
Ability to interpret regulatory standards and guidance and provide direction to project teams.
Ability to work in a fast-paced, technically challenging environment where drive is critical to success.
Self-motivated and self-disciplined; able to prioritize multiple tasks and responsibilities.
Effective interpersonal skills/diplomacy and problem-solving techniques.
Excellent applied thinking and technical writing skills.
Strong communication and organization skills required.

Skills and Abilities Required for This Job:

Strong verbal and written communication, organization, and project management skills required.
Works on problems of diverse scope and analyzes data and information to make sound decisions, recommendations, and regulatory filings of high quality.
Self-directed with minimum instruction on routine work, and general instruction on new assignments.
Ability to handle challenges and uncertain circumstances, with adaptability to shifting company priorities.
Exercises good judgment within generally defined practices and policies in all aspects of the job.
Diplomacy and cultural sensitivity are essential attributes.
Software proficiency in Microsoft Office Suite.
The employee must occasionally lift and/or move up to 20 pounds.

Physical Requirements:

Ability to travel up to 20%.

Quick Apply

Refine Your Search

regulatory project manager jobs in orange, ca

Project Manager, Regulatory Affairs

Pipeliner Entry - Orange

Principal Engineering Lead

Proposal Administrator

Supervisor, Procurement - IT Procurement

Game Product Manager (Chinese Mandarin Speaker)

Senior Import Logistics Operations /Customer Services

Public Works Labor Compliance Specialist

Director of Fabrication

Facilities and EHS Manager

Healthcare Facility Manager

Special Projects Manager

Accounting Manager (Bilingual in Korean)

Call Center Manager (Healthcare)

VP, Operational Risk Business Partner - Risk Management

OSP Construction Manager - Orange County, CA

VP, Sr. Loan Review Officer / VP, Loan Review Officer

Paralegal, Regulatory Compliance

Treasury Management Implementation & Support Operations Officer (NE)

Water Treatment Design Lead

I want to receive the latest job alert for regulatory project manager in orange, ca

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected