Top 1288 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
Proposal Administrator
EEC Environmental —Orange, CA
- $90,000 - $110,000 a year
- Full-time
- Microsoft Excel
- Marketing
- 5 years
- Profit sharing
- Paid holidays
12d
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
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
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
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
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
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VP, Sr. Manager, Professional Practices Audit
Cathay Bank —El Monte, CA
- $180,000 - $185,000 a year
- Full-time
- CPA
- Writing skills
- Research
- Health savings account
- Disability insurance
Quick Apply
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
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
VP, High-Risk AML Manager
Cathay Bank —Monterey Park, CA
- $94,900 - $110,000 a year
- Full-time
- 5 years
- Office
- Finance
- Health savings account
- Disability 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
FIELD ARCHAEOLOGISTS - (Central California)
SummitWest Environmental —California
- $27 - $32 an hour
- Part-time
- Microsoft Word
- Background check
- Clean driving record
- Health insurance
- Dental insurance
Quick Apply
Assistant Deputy Director - Capital Project Delivery
County of Orange —Orange County, CA
- $140,670.40 - $194,833.60 a year
- Weekends as needed
- Background check
- Construction site
- Engineering
14d
Floating Senior Community Manager - Affordable LIHTC/HUD/PSH
Quality Management Group Inc —Ontario, CA
- $33 - $35 an hour
- Full-time
- Computer literacy
- Mid-level
- Driver's License
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
1d
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
Tax Director
Talnt —Irvine, CA
- $180,000 - $270,000 a year
- Full-time
- CPA
- Research
- Office
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
VP, New Account Manager
Cathay Bank —Rosemead, CA
- $93,400 - $110,400 a year
- Full-time
- Microsoft Word
- Microsoft Excel
- Microsoft Outlook
- Health savings account
- Disability insurance
Quick Apply

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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

Proposal Administrator

Principal Engineering Lead

Supervisor, Procurement - IT Procurement

Healthcare Facility Manager

Call Center Manager (Healthcare)

Facilities and EHS Manager

VP, Sr. Manager, Professional Practices Audit

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

Special Projects Manager

VP, High-Risk AML Manager

Senior Import Logistics Operations /Customer Services

FIELD ARCHAEOLOGISTS - (Central California)

Assistant Deputy Director - Capital Project Delivery

Floating Senior Community Manager - Affordable LIHTC/HUD/PSH

Director of Fabrication

VP, Operational Risk Business Partner - Risk Management

Tax Director

Treasury Management Implementation & Support Operations Officer (NE)

VP, New Account Manager

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