Top 34 Regulatory affairs manager Jobs in Pleasanton, Ca

Manager, Regulatory Affairs
Noctrix Health —Pleasanton, CA
- $150,000 - $180,000 a year
- Full-time
- Hybrid work
- 5 years
- Engineering
- Office
Quick Apply
3d
Sr. Manager, Regulatory Affairs
Vaxcyte —San Carlos, CA
- $183,000 - $194,000 a year
- Full-time
- Bachelor of Science
- Bachelor's degree
- Computer skills
Senior Manager, Regulatory Affairs - Lingo (on-site)
Abbott Laboratories —Alameda, CA
- $130,700 - $261,300 a year
- Full-time
- Master's degree
- Bachelor's degree
- Recruiting
- Health insurance
- Tuition reimbursement
Manager, Regulatory Affairs CMC
Gilead Sciences —Foster City, CA
- $146,540 - $189,640 a year
- Full-time
- Bachelor's degree
- Continuous improvement
- Senior level
- Health insurance
- Dental insurance
Regulatory Operations Manager
Siemens Healthineers —Palo Alto, CA
- $129,900 - $178,618 a year
- Full-time
- 5 years
- Office
- Master's degree
- Disability insurance
- Health insurance
5d
Sr Manager, Regulatory Affairs CMC, Combination Products and Device
Gilead Sciences —Foster City, CA
- $157,590 - $203,940 a year
- Full-time
- Bachelor of Science
- Bachelor's degree
- Continuous improvement
- Health insurance
- Dental insurance
5d
Regulatory Affairs Manager – Heart Failure (on-site)
Abbott Laboratories —Pleasanton, CA
- $114,000 - $228,000 a year
- Full-time
- 6 years
- Supervising experience
- Bachelor's degree
- Health insurance
- Tuition reimbursement
Regulatory Affairs Manager – Diabetes Care (on-site)
Abbott Laboratories —Alameda, CA
- $114,000 - $228,000 a year
- Full-time
- Office
- Master's degree
- Bachelor's degree
- Health insurance
- Tuition reimbursement
Sr. Manager/Associate Director, Regulatory Affairs
Oruka Therapeutics —Menlo Park, CA
- $161,000 - $208,000 a year
- Office
- 8 years
- Bachelor's degree
- Employee stock purchase plan
- Health insurance
Manager, Regulatory Response
Google —Mountain View, CA
- $211,000 - $293,000 a year
- Full-time
- Office
- Supervising experience
- Bachelor's degree
- Paid holidays
- Disability insurance
3d
Program Manager, Regulatory Program Management Office
Google —Mountain View, CA
- $136,000 - $196,000 a year
- Full-time
- 5 years
- Office
- Bachelor's degree
Senior Program Manager, Regulatory Compliance
Google —Sunnyvale, CA
- $164,000 - $239,000 a year
- Full-time
- Office
- Bachelor's degree
- Fair chance
3d
Principal Regulatory Affairs Specialist – Vascular (on-site)
Abbott Laboratories —Santa Clara, CA
- $100,000 - $200,000 a year
- Full-time
- 6 years
- Bachelor's degree
- Product management
- Health insurance
- Tuition reimbursement
Senior Manager, Commercial Regulatory Operations
Corcept Therapeutics —Redwood City, CA
- $194,000 - $227,000 a year
- Hybrid work
- 6 years
- Bachelor of Science
- Office
Quick Apply
Regulatory Affairs Associate (Principal) - Medical Devices
Apple —Cupertino, CA
- $178,400 - $297,200 a year
- Bachelor of Science
- Team management
- Experience equivalent to degree accepted
- Employee stock purchase plan
- Health insurance
Safety Program Manager (Trust building), TikTok Platform Responsibility
TikTok —San Jose, CA
- $108,000 - $208,800 a year
- Office
- Fair chance
- Senior level
- Paid parental leave
- Paid holidays
Program Manager, Specialized Risk Assessment
Meta —Menlo Park, CA
- $153,000 - $209,000 a year
- 7 years
- Writing skills
- Bachelor's degree
6d
Senior Project Manager (Product Lifecycle Manager)
Abbott Laboratories —Pleasanton, CA
- $114,000 - $228,000 a year
- Full-time
- 7 years
- Management
- Bachelor's degree
- Health insurance
- Tuition reimbursement
Director Program Manager, Product Launch (Rare Disease)
Rezolute —Redwood City, CA
- $240,000 - $290,000 a year
- Full-time
- Office
- 8 years
- Bachelor's degree
- Paid holidays
- Disability insurance
Quick Apply
Program Manager, CRDMO
GeneFab —Alameda, CA
- $140,000 - $200,000 a year
- Full-time
- 5 years
- Bachelor's degree
- Doctor of Philosophy
Quick Apply
5d

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Manager, Regulatory Affairs

Noctrix Health
Pleasanton, CA

Quick Apply

Job Details

Full-time
$150,000 - $180,000 a year
3 days ago

Qualifications

FDA submissions
Content creation for technical audiences
Adverse event reporting
Technical documentation
Labeling
Schedule management
Project management experience in healthcare
Leading team collaboration initiatives
Regulatory submission editing and review
Biomedical regulatory compliance
Managing projects
Technical writing experience within technology
Cross-functional team management
Project stakeholder communication
Cross-functional communication
Product lifecycle management

Full Job Description

Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is dedicated to delivering prescription-grade therapy with an outstanding user experience. We have pioneered the world's first drug-free wearable therapy, clinically proven to alleviate symptoms in adults with drug-resistant Restless Legs Syndrome (RLS). Join us in transforming healthcare, improving lives, and driving meaningful change through innovative medical technology.

We are seeking an experienced and highly organized Manager, Regulatory Affairs to lead and execute regulatory activities supporting the development, registration, commercialization, and post-market compliance of Noctrix Health's medical devices. This role will help ensure regulatory strategies and deliverables are executed accurately, compliantly, and on schedule throughout the product lifecycle.

The Manager, Regulatory Affairs will work closely with Clinical Affairs, Quality, Engineering, Operations, Marketing, and external regulatory partners to provide regulatory guidance, manage submissions, assess product changes, maintain global registrations, and support post-market regulatory activities. The ideal candidate combines strong medical device regulatory expertise with excellent project management skills and the ability to independently drive complex regulatory initiatives across multiple functions.

This position reports to the Senior Vice President, Clinical & Regulatory Affairs.

This is a full-time, hybrid position that is located at our Pleasanton headquarters.

Responsibilities:

Provide regulatory guidance to cross-functional teams supporting new product development, design changes, risk management, commercialization, and product lifecycle activities
Perform and maintain regulatory assessments for product modifications, software and firmware updates, labeling changes, manufacturing changes, and new product development activities
Serve as the Regulatory Affairs project lead for FDA and international regulatory submissions, developing submission strategies, timelines, deliverables, and cross-functional execution plans
Prepare, review, compile, and submit regulatory applications, technical documentation, and responses to regulatory authorities
Support and manage U.S. regulatory submissions, including 510(k) submissions and other applicable premarket activities
Support international regulatory submissions and registrations across applicable global markets
Maintain product registrations, establishment registrations, regulatory listings, licenses, and other required regulatory records
Track regulatory commitments, submission milestones, renewals, and reporting requirements to ensure timely completion
Serve as a primary Regulatory Affairs liaison with external partners, including European Authorized Representatives, regulatory consultants, and applicable regulatory authorities
Review and approve promotional, advertising, labeling, and marketing materials to ensure compliance with applicable regulations and approved product claims
Lead post-market regulatory reporting and vigilance activities, including assessment, submission, tracking, and documentation of reportable events
Perform Medical Device Reporting (MDR) assessments and support reporting determinations in accordance with applicable regulatory requirements
Collaborate with Quality, Clinical Affairs, and Post-Market Surveillance teams to support complaint trend reporting, PSURs, periodic regulatory reports, and other post-market deliverables
Administer and maintain regulatory electronic submission platforms and accounts, including FDA Electronic Submission Gateway (ESG), WebTrader, and other applicable regulatory systems
Monitor evolving U.S. and international regulatory requirements and assess potential impacts to products, processes, registrations, and regulatory strategies
Communicate regulatory changes, risks, requirements, and recommendations to cross-functional stakeholders and leadership
Support regulatory inspections, audits, agency inquiries, and Quality System activities related to Regulatory Affairs
Identify opportunities to improve regulatory processes, documentation, tracking, and cross-functional execution as the organization grows

Requirements:

Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or a related scientific or technical discipline
Minimum of 5 years of Regulatory Affairs experience within the medical device industry
Demonstrated experience with medical device regulatory submissions, post-market regulatory compliance, and product lifecycle management
Strong working knowledge of FDA medical device regulations, Medical Device Reporting requirements, and applicable international regulatory frameworks
Experience performing regulatory assessments for new product development, design changes, software or firmware updates, labeling changes, and product modifications
Experience preparing, supporting, or managing 510(k) submissions
Experience supporting international or OUS medical device registrations and submissions
Knowledge of post-market vigilance requirements, complaint reporting, MDR assessments, and applicable regulatory reporting obligations
Experience reviewing promotional, advertising, labeling, or marketing materials for regulatory compliance
Strong project management skills with demonstrated ability to coordinate complex regulatory deliverables across multiple functions
Strong technical writing skills with experience preparing regulatory documentation and communicating complex information clearly
Ability to independently manage multiple regulatory projects, priorities, and deadlines
Excellent written and verbal communication skills with the ability to collaborate effectively with internal stakeholders, external partners, and regulatory authorities
Strong attention to detail and commitment to regulatory documentation accuracy and compliance

Preferred Qualifications:

Advanced degree in Regulatory Affairs, Engineering, Life Sciences, or a related discipline
Regulatory Affairs Certification (RAC)
Experience within a startup or growth-stage medical device organization
Experience serving as the regulatory lead or project manager for successful 510(k) submissions
Experience with EU MDR and international medical device registrations
Experience supporting connected, wearable, software-enabled, or electro-medical devices
Experience with software and firmware change assessments
Experience preparing or supporting PSURs and other post-market regulatory deliverables
Experience interacting directly with FDA or other regulatory authorities
Experience supporting FDA inspections, notified body audits, or other regulatory inspections

Compensation:

Base Pay: $150,000–$180,000 per year
Annual Bonus Eligibility

Quick Apply

Refine Your Search

regulatory affairs manager jobs in pleasanton, ca

Manager, Regulatory Affairs

Sr. Manager, Regulatory Affairs

Senior Manager, Regulatory Affairs - Lingo (on-site)

Manager, Regulatory Affairs CMC

Regulatory Operations Manager

Sr Manager, Regulatory Affairs CMC, Combination Products and Device

Regulatory Affairs Manager – Heart Failure (on-site)

Regulatory Affairs Manager – Diabetes Care (on-site)

Sr. Manager/Associate Director, Regulatory Affairs

Manager, Regulatory Response

Program Manager, Regulatory Program Management Office

Senior Program Manager, Regulatory Compliance

Principal Regulatory Affairs Specialist – Vascular (on-site)

Senior Manager, Commercial Regulatory Operations

Regulatory Affairs Associate (Principal) - Medical Devices

Safety Program Manager (Trust building), TikTok Platform Responsibility

Program Manager, Specialized Risk Assessment

Senior Project Manager (Product Lifecycle Manager)

Director Program Manager, Product Launch (Rare Disease)

Program Manager, CRDMO

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