Top 65 Director of regulatory affairs Jobs in Irvine, Ca

Director, Regulatory Affairs
Diality —Irvine, CA
- $205,000 - $230,000 a year
- 7 years
- Bachelor of Science
- Engineering
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Director, Regulatory Affairs Strategy
Alcon —Lake Forest, CA
- Full-time
- Doctoral degree
- High school
- 11+ years
- Disability insurance
- Health insurance
Adjunct Faculty, Online Teaching - Healthcare Administration
Pacific College —Costa Mesa, CA
- $3,600 a week
- Part-time
- Remote
- Mid-level
- Master's degree
- Communication skills
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Government Affairs Director
T-Mobile USA, Inc. —Santa Ana, CA
- $174,300 - $235,800 a year
- Full-time
- Hybrid work
- 18 years or older
- Bachelor's degree
- US work authorization
- Paid parental leave
- AD&D insurance
Manager II, Regulatory Affairs
Tarsus Pharmaceuticals —Irvine, CA
- $120,000 - $168,000 a year
- Hybrid work
- Management
- 8 years
- Bachelor's degree
- Paid holidays
- Dental insurance
Associate Director, 340B Strategy & Innovation
AbbVie —Irvine, CA
- $141,500 - $268,500 a year
- Full-time
- Hybrid work
- Master's degree
- Bachelor's degree
- Conflict management
- Paid holidays
- Health insurance
Senior Manager, Regulatory Affairs Strategy
Alcon —Lake Forest, CA
- $167,450 - $216,700 a year
- Full-time
- Doctoral degree
- High school
- 11+ years
- Health insurance
- Paid time off
Regulatory Affairs Specialist
Prelude DX —Laguna Hills, CA
- $90,000 - $140,000 a year
- Monday to Friday
- 6 years
- Engineering
- Office
Associate Director, Regulatory Affairs US & Canada Strategy Lead – Facial Aesthetics - Device
AbbVie —Irvine, CA
- $141,500 - $268,500 a year
- Full-time
- Hybrid work
- Doctor of Philosophy
- Team management
- Mentoring
- Paid holidays
- Health insurance
2d
Director, Portfolio Program Management
AbbVie —Irvine, CA
- $160,500 - $305,000 a year
- Full-time
- Hybrid work
- 5 years
- Bachelor of Science
- Analysis skills
- Paid holidays
- Health insurance
Director of RA CMC Knowledge Management & Strategy
AbbVie —Irvine, CA
- $182,000 - $346,000 a year
- Full-time
- Hybrid work
- Doctor of Philosophy
- Senior level
- Leadership
- Paid holidays
- Health insurance
14d
Regulatory Affairs Coordinator
University of California, Irvine —Orange, CA
- $35.77 - $58.96 an hour
- Full-time
- Background check
- Microsoft Excel
- Microsoft Outlook
- Health insurance
- Retirement plan
Director, RA Global Regulatory Strategy
AbbVie —Irvine, CA
- $182,000 - $346,000 a year
- Full-time
- Hybrid work
- 7 years
- Bachelor's degree
- Mentoring
- Paid holidays
- Health insurance
Associate Director, Emerging Channel Insights & Analytics -Market Access & Patient Services
AbbVie —Irvine, CA
- $141,500 - $268,500 a year
- Full-time
- Hybrid work
- 5 years
- Writing skills
- Bachelor's degree
- Paid holidays
- Health insurance
Government Relations & Partnerships Lead (SMR / MMR Programs)
BaRupOn LLC —Irvine, CA
- Full-time
- PMP
- Master's degree
- 8 years
Quick Apply
Policy & Government Relations Analyst
Vast —Long Beach, CA
- $90,000 - $128,000 a year
- Full-time
- Mid-level
- Office
- Business development
- Paid parental leave
- Disability insurance
20h
Director of Clinical Research Administration & Finance
University of California, Irvine —Orange, CA
- $149,700 - $297,700 a year
- Weekends as needed
- Background check
- 5 years
- Office
- Health insurance
- Retirement plan
Director, R&D Quality Assurance
Alcon —Lake Forest, CA
- $183,600 - $237,600 a year
- Full-time
- Doctoral degree
- Surgery
- High school
- Health insurance
Associate Director/Manager, Field Medical Affairs
Dendreon Corporation —Seal Beach, CA
- $146,250 - $220,000 a year
- Weekends as needed
- Medicine
- Office
- 3 years
Director of Licensing & Regulatory Affairs (SMR / MMR Programs)
BaRupOn LLC —Irvine, CA
- Full-time
- PMP
- Master's degree
- Analysis skills
Quick Apply

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Director, Regulatory Affairs

Diality
Irvine, CA

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Job Details

$205,000 - $230,000 a year

Qualifications

FDA submissions
Content creation for technical audiences
Team leadership
Technical documentation
Clinical research compliance
Participating in conferences
Regulatory submission editing and review
Biomedical regulatory compliance
Document viewing software
Technical project management
Technical writing experience within technology
Adobe Acrobat
ISO 13485
International trade regulations
Customer complaint resolution

Full Job Description

Description:

Company & Job Overview

Diality is a medical device company focused on developing solutions to improve lives impacted by kidney disease. Diality offers the Moda-flx Hemodialysis System, a user-friendly, mobile, and connected hemodialysis system designed to maximize clinical flexibility and ease-of-use for both clinical and non-clinical users. The Moda-flx Hemodialysis system combines flow rate capabilities of conventional in-center dialysis devices with a fully integrated reverse osmosis (RO) water filtration system to provide a broad range of prescriptions and meet the needs of any professional dialysis care setting.

The Regulatory Affairs Director is responsible for overseeing, developing, and influencing regulatory policy and determining and pursuing courses of action necessary to obtain regulatory clearance and approval for the Diality products. The Regulatory Affairs Director is responsible for planning and executing regulatory activities necessary to obtain and maintain regulatory approvals within the United States and other countries. This position is also responsible for supporting the Quality Management System and will serve as the Regulatory Affairs lead on product teams. The Regulatory Affairs Director will also act as the Regulatory Responsible Person as defined by the EU MDR.

Responsibilities

Develops regulatory strategic plans and provides support to ensure adherence with global regulatory requirements as appropriate. Supports overall regulatory strategy during product development, manufacturing, market launch, and post-market surveillance.
Plans and prepares regulatory submissions for new products and product changes to ensure timely approval for clinical studies and market release that include, but are not limited to, the following:

a. US FDA Investigational Device Exemption (IDE)

b. US FDA 510(k)

c. CE Marking under EU MDR

d. Product amendments to existing regulatory approvals/clearances

Serves as the primary contact with US Food and Drug Administration (FDA) and liaises with other country Regulatory Agencies, when needed, directly or in coordination with local country representation.
Represents Diality in cross-industry regulatory initiatives
Responsible for obtaining and maintenance of, but not limited to, the following:

a. Local, State and National Regulatory licensing and registration renewals

b. Import/Export Permits

Assesses product and manufacturing changes and develops regulatory assessments for each market as to impact upon current approvals. Prepares well-justified Letters to File (LTFs) if appropriate.
Provides assistance and regulatory guidance regarding product labeling, marketing materials and social media.
Provides oversight for Regulatory processes and systems. Facilitate and support the implementation of various Regulatory process improvement projects by working directly with key stakeholders to accelerate market access routes and ensure compliance. Lead compliance initiatives relating to Regulatory requirements.
Supports Quality System projects and activities such as, but not limited to, the following:

a. Complaint Handling

Supports Clinical and Commercial functions in post-market vigilance and clinical follow-up activities, including related regulatory reporting.
Provide Oversite and acts as the primary interface with regulatory and other party certification agencies in Product Recalls, Field Related activities and Corrections and Product adverse event reporting collaborate with and supported by Director of Quality
Leads inspections/audits by the notified body or other international regulatory Agencies by producing requested documents or answering any inquiries for information.
Supports the Director, Quality during internal and external (i.e. FDA, etc.) Quality inspections/audits.
Participates in and review risk management activities/documents and ensure compliance with ISO 14971.
Monitors product development, manufacturing, and post-market data to ensure appropriate updates to the risk management, design history, technical files, and post-market surveillance reports are incorporated in a timely manner.
Maintains a “big picture” perspective, taking personal responsibility for actions and maintaining a commitment to regulatory compliance, quality, ethics, and integrity.

Requirements:

Required Skills & Abilities

Demonstrated excellence in developing global regulatory affairs strategies for medical products
Broad-based technical knowledge and skills in diverse areas of business such as Engineering, Operations, Quality, Marketing, Clinical Research, etc.
Ability to effectively negotiate and influence cross-functional stakeholders, affiliates, and Regulatory authorities is a plus
Proven track record of maintaining regulatory knowledge and skills by participating in industry conferences/seminars
Comprehensive knowledge of laws and regulations applicable in an FDA-regulated environment
Strong working knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR regulations
Knowledge and understanding of other foreign country regulations and international device registration a plus
Good knowledge of clinical evaluation and investigation of medical devices
Excellent interpersonal skills including ability to interact with a high degree of diplomacy
Excellent problem-solving, applied thinking and technical writing skills
Excellent communication and organization skills required
Ability to work in a fast-paced, technically challenging environment where drive is critical to success
Expertise in Microsoft Office and Adobe Acrobat applications
Familiarity with dialysis and end-stage renal disease is a plus

Education & Experience

Minimum science or engineering BS degree with at least 10+ years of medical device regulatory affairs experience or a Regulatory Affairs MS or PhD with at least 7+ years of medical device regulatory affairs experience
Certification in regulatory affairs (RAC) preferred
2+ years of Regulatory Affairs leadership in a small/start-up company environment, as demonstrated by previous employment roles and responsibilities
Previous experience interacting directly with FDA is required
Experience reviewing and approving technical documentation
US and EU medical device regulatory submission experience required
Hands-on experience with 510(k) and Technical File/Design Dossier submissions
Strategic thinker, strong leadership and interpersonal communication skills, assertiveness, strong technical background, strong analytical skills, well organized, and excellent negotiation, and project management skills as a regulatory lead on projects
Product development team experience

Travel

Ability to travel (domestic and international) as required, approximately 10%

Physical Requirements

Prolonged periods of sitting at a desk and working on a computer
May be expected to lift 15 pounds at times

Working Environment:

Office or work-station environment
Remote work environment is also an option for this position

The information contained in this job description is for compliance with the Americans with Disabilities Act (ADA) and is not an exhaustive list of duties performed for this position.

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Refine Your Search

director of regulatory affairs jobs in irvine, ca

Director, Regulatory Affairs

Director, Regulatory Affairs Strategy

Adjunct Faculty, Online Teaching - Healthcare Administration

Government Affairs Director

Manager II, Regulatory Affairs

Associate Director, 340B Strategy & Innovation

Senior Manager, Regulatory Affairs Strategy

Regulatory Affairs Specialist

Associate Director, Regulatory Affairs US & Canada Strategy Lead – Facial Aesthetics - Device

Director, Portfolio Program Management

Director of RA CMC Knowledge Management & Strategy

Regulatory Affairs Coordinator

Director, RA Global Regulatory Strategy

Associate Director, Emerging Channel Insights & Analytics -Market Access & Patient Services

Government Relations & Partnerships Lead (SMR / MMR Programs)

Policy & Government Relations Analyst

Director of Clinical Research Administration & Finance

Director, R&D Quality Assurance

Associate Director/Manager, Field Medical Affairs

Director of Licensing & Regulatory Affairs (SMR / MMR Programs)

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