Top 2836 Risk specialist Jobs in California

Senior Regulatory Affairs Specialist
PROCEPT BioRobotics Corporation —San Jose, CA
- $148,550 - $174,770 a year
- Full-time
- Bachelor of Science
- Analysis skills
- Bachelor's degree
- Opportunities for advancement
Quick Apply
Emergency Management Specialist
UCLA Health —Los Angeles, CA
- $82,434.24 - $171,779.76 a year
- Microsoft Outlook
- Writing skills
- Mid-level
4d
Principal Regulatory Affairs Specialist
PROCEPT BioRobotics Corporation —San Jose, CA
- Full-time
- Microsoft Excel
- 11+ years
- Research
- Opportunities for advancement
Quick Apply
Principal Regulatory Affairs Specialist
PROCEPT BioRobotics Corporation —San Jose, CA
- $220,670 - $259,610 a year
- Full-time
- Microsoft Excel
- 11+ years
- Research
- Opportunities for advancement
Quick Apply
Specialist, Fleet Safety w/CDL
Airgas, Inc. —North Hollywood, CA
- Full-time
- CDL A
- Children
- Travel
- Paid jury duty
- Commuter assistance
Risk Operations Specialist, Payments
Ramp —San Francisco, CA
- $100,000 - $184,000 a year
- Full-time
- Hybrid work
- Bachelor of Science
- Mid-level
- SQL
- Travel reimbursement
- AD&D insurance
Learning Specialist
UCLA —Los Angeles, CA
- $68,800 - $141,000 a year
- Full-time
- Hybrid work
- Background check
- Writing skills
- Mid-level
2d
Investigations Security Specialist
Citizens Financial Group —San Francisco, CA
- $170,000 - $230,000 a year
- Full-time
- Background check
- 5 years
- Research
- Health insurance
- Dental insurance
7d
Legal Specialist
Aivres —Milpitas, CA
- $80,000 - $150,000 a year
- Email
- Writing skills
- Mid-level
- Office
Claims Training Specialist
CorVel Corporation —Folsom, CA
- $77,960 - $120,368 a year
- Full-time
- Remote
- Classroom
- Computer literacy
- HIPAA
- Health savings account
- Disability insurance
Quick Apply
Clinical & Healthcare Risk Specialist II - SMCS & SCP
Sutter Health —Sacramento, CA
- $106,745.60 - $160,118.40 a year
- Full-time
- Customer service
- Writing skills
- Mid-level
7d
Risk Investigations Specialist - Trust & Safety
Control Risks —San Francisco, CA
- $100,000 - $110,000 a year
- Weekends as needed
- Remote
- SQL
- US work authorization
- Organizational skills
- AD&D insurance
- Health insurance
Quick Apply
Information Security Risk and Governance Specialist, Consultant
Blue Shield of California —El Dorado Hills, CA
- $123,090 - $184,800 a year
- Full-time
- Hybrid work
- Background check
- 7 years
- Pass drug screening
- Work from home
Clinical Documentation Specialist, Clinician
Sutter Health —Sacramento, CA
- $42.95 - $121.23 an hour
- 8 hour shift
- Nursing
- RN License
- Customer service
Compliance Specialist
Sony Pictures Entertainment Inc. —Culver City, CA
- $77,000 - $90,000 a year
- Full-time
- Hybrid work
- Microsoft Word
- Mid-level
- Bachelor's degree
EHS Specialist
Tesla —Fremont, CA
- $76,000 - $144,000 a year
- Full-time
- Microsoft Excel
- Customer service
- Mid-level
- Commuter assistance
- Health savings account
Executive Protection Specialist
Snapchat —Los Angeles, CA
- $133,000 - $235,000 a year
- Weekends as needed
- Hybrid work
- Office
- Residential
- Driver's License
- Paid parental leave
- Health insurance
Executive Security Services Specialist
Capital Group Companies —Los Angeles, CA
- $125,909 - $201,454 a year
- Full-time
- Clean driving record
- Management
- Office
- Health insurance
- Benefits from day one
Loss Control Specialist
Marathon Petroleum Company LP —Carson, CA
- $93,000 - $160,300 a year
- Full-time
- Mid-level
- Bachelor's degree
- Mentoring
- Paid parental leave
- Dental insurance
2d
Legal Contracts Specialist
Sac Health —San Bernardino, CA
- $95,867.20 - $114,878.40 a year
- Full-time
- Mid-level
- Clinic
- Travel
- Paid jury duty
- Paid holidays
Quick Apply
8d

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Senior Regulatory Affairs Specialist

PROCEPT BioRobotics Corporation -
San Jose, CA

Quick Apply

Job Details

Full-time
$148,550 - $174,770 a year

Benefits

Opportunities for advancement

Qualifications

Program management
ISO standards
Biomedical regulatory compliance

Full Job Description

Company Overview

Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities.

Understanding PROCEPT's Culture

At PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do, while also working together seamlessly for a common goal. At Procept, curiosity, ingenuity and conviction in the power technology will transform the lives of our patients and providers.

And this doesn’t happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procept’s history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens.

We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept, we push beyond just finding a work/life balance, we strive to find a work/life blend, a professional world that you are honored and impassioned to belong to, one that you can proudly share with your family, friends, and acquaintances.

An opportunity at PROCEPT BioRobotics won’t just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world!

The Opportunity That Awaits You

Are you ready to embark on an exciting journey that will revolutionize the way men suffering from BPH are treated? Join us as a Senior Regulatory Affairs Specialist and be at the forefront of regulatory science for medical robotics. Your mission? To support a deep culture of compliance while advocating for breakthrough medical innovations in the space of urological surgery. You’ll be providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class II and III devices and preparing and submitting regulatory submissions in the US, EU and outside of US (OUS) geographies.

What Your Day-To-Day Will Involve

Act as a lead regulatory representative on product development teams, communicate regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements
Develop global regulatory strategies for new and modified products
Support the monitoring and interpreting of current and new regulatory requirements and international standards for U.S. and Rest of World (RoW)
Support regulatory effort to comply with new and existing regulations (e.g., FDA Medical Device Regulations, EU-MDR)
Independently identify and problem solve regulatory and compliance issues, and escalate to senior management as necessary
Provide effective communication, and quick responses to internal customers
Drive continuous improvement in internal processes and customer satisfaction
Identify, develop, and mentor high performing regulatory talent
Assure that US FDA Quality Management System (QMSR) requirements are followed and executed consistently from RA perspective
Execute US FDA 510(k) and Technical File creation and remediation, collaborating with cross-functional teams for required content
Draft and execute comprehensive regulatory impact assessments for design control changes to existing products
Performs other duties and assignments as required

The Qualifications We Need You to Possess

Bachelor’s Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications)
6 years’ experience with a B.S. or 4 years’ experience with a M.S. in regulatory submissions for medical devices
Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC)
Ability to work effectively on project teams
Must be able to manage multiple and competing priorities and manage programs with minimal oversight

The Qualifications We Would Like You to Possess

M.S. or Ph.D. in a technical area
Experience working with both Class II and Class III medical devices.
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society)
Has a strong attention-to-detail
Strong written, verbal, presentation, and organizational skills
Strong analytical and problem-solving skills
Working knowledge of relevant ISO and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies
Ability to identify risk areas and escalate issues as appropriate

Pay Range for this role:

$148,550 to $174,770

Quick Apply

Refine Your Search

risk specialist jobs in california

Senior Regulatory Affairs Specialist

Emergency Management Specialist

Principal Regulatory Affairs Specialist

Principal Regulatory Affairs Specialist

Specialist, Fleet Safety w/CDL

Risk Operations Specialist, Payments

Learning Specialist

Investigations Security Specialist

Legal Specialist

Claims Training Specialist

Clinical & Healthcare Risk Specialist II - SMCS & SCP

Risk Investigations Specialist - Trust & Safety

Information Security Risk and Governance Specialist, Consultant

Clinical Documentation Specialist, Clinician

Compliance Specialist

EHS Specialist

Executive Protection Specialist

Executive Security Services Specialist

Loss Control Specialist

Legal Contracts Specialist

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