Top 19 Regulatory affairs specialist Jobs in Mountain View Ca

Staff Regulatory Affairs Specialist
PROCEPT BioRobotics Corporation —San Jose, CA
- Full-time
- 6 years
- Bachelor of Science
- Analysis skills
- Opportunities for advancement
Quick Apply
Regulatory Affairs Specialist IV
System One —Mountain View, CA
- $55 - $60 an hour
- Contract
- Bachelor of Science
- Office
- 8 years
- Health insurance
- Dental insurance
Quick Apply
Regulatory Affairs Specialist
Abbott Laboratories —Pleasanton, CA
- $73,900 - $116,000 a year
- Full-time
- 18 years or older
- No experience needed
- Research
- Health insurance
- Tuition reimbursement
12d
Senior Regulatory Affairs Specialist
Abbott Laboratories —Santa Clara, CA
- $90,000 - $180,000 a year
- Full-time
- 18 years or older
- 3 years
- Master's degree
- Health insurance
- Tuition reimbursement
Regulatory Affairs Specialist II
The Clorox Company —Pleasanton, CA
- $75,800 - $170,100 a year
- Full-time
- Bachelor of Science
- Office
- Bachelor's degree
- Health insurance
- Adoption assistance
12d
Senior Regulatory Affairs Specialist – Heart Failure (on-site)
Abbott Laboratories —Pleasanton, CA
- $90,000 - $180,000 a year
- Full-time
- Word processing
- Writing skills
- Office
- Health insurance
- Tuition reimbursement
Regulatory Affairs Specialist II
Thermo Fisher Scientific —Fremont, CA
- $72,000 - $96,000 a year
- Full-time
- Background check
- No experience needed
- Mid-level
- Commuter assistance
- Paid parental leave
Regulatory Affairs Specialist - Vascular (on-site)
Abbott Laboratories —Santa Clara, CA
- $81,500 - $141,300 a year
- Full-time
- Mid-level
- Office
- Master's degree
- Health insurance
- Tuition reimbursement
Regulatory Affairs Specialist III
Thermo Fisher Scientific —Fremont, CA
- $90,900 - $121,200 a year
- Full-time
- Background check
- Pass drug screening
- Office
- Commuter assistance
- Paid parental leave
Specialist, Regulatory Affairs Operations Publishing
Taiho Oncology, Inc. —Pleasanton, CA
- $86,700 - $102,000 a year
- Full-time
- Hybrid work
- Mid-level
- Organizational skills
- Fair chance
- Paid time off
- Parental leave
Quick Apply
Senior Regulatory Affairs Specialist
Hyperfine —Palo Alto, CA
- $145,000 - $167,000 a year
- Weekends as needed
- Hybrid work
- 5 years
- Office
- Bachelor's degree
Quick Apply
Senior Regulatory Affairs Specialist – Vascular (on-site)
Abbott Laboratories —Santa Clara, CA
- $90,000 - $180,000 a year
- Full-time
- Office
- 3 years
- Master's degree
- Health insurance
- Tuition reimbursement
Sr. Regulatory Affairs Specialist , Medical Devices Operational Compliance Center (MD-OCC)
Amazon.com Services LLC —Sunnyvale, CA
- $171,000 - $231,400 a year
- Full-time
- 5 years
- Analysis skills
- Bachelor's degree
- AD&D insurance
- Health insurance
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 Regulatory Affairs Specialist
PROCEPT BioRobotics Corporation —San Jose, CA
- Full-time
- Bachelor of Science
- Analysis skills
- Bachelor's degree
- Opportunities for advancement
Quick Apply
8d
Principal Regulatory Affairs Specialist
PROCEPT BioRobotics Corporation —San Jose, CA
- Full-time
- Microsoft Excel
- 11+ years
- Research
- Opportunities for advancement
Quick Apply
8d

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Staff Regulatory Affairs Specialist

PROCEPT BioRobotics Corporation -
San Jose, CA

Quick Apply

Job Details

Full-time

Benefits

Opportunities for advancement

Qualifications

FDA submissions
Customer communication
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!

Company Overview

Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. We 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.

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 Staff 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 core product development teams, communicates 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)
Lead 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)
8 years experience with a B.S. or 6 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:

Quick Apply

Refine Your Search

regulatory affairs specialist jobs in mountain view ca

Staff Regulatory Affairs Specialist

Regulatory Affairs Specialist IV

Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Regulatory Affairs Specialist II

Senior Regulatory Affairs Specialist – Heart Failure (on-site)

Regulatory Affairs Specialist II

Regulatory Affairs Specialist - Vascular (on-site)

Regulatory Affairs Specialist III

Specialist, Regulatory Affairs Operations Publishing

Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist – Vascular (on-site)

Sr. Regulatory Affairs Specialist , Medical Devices Operational Compliance Center (MD-OCC)

Principal Regulatory Affairs Specialist – Vascular (on-site)

Senior Regulatory Affairs Specialist

Principal Regulatory Affairs Specialist

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