Top 5 Regulatory affairs specialist Jobs in Uc Berkeley Ca

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
12d
Senior Regulatory Affairs Specialist – Lingo (on-site)
Abbott Laboratories —Alameda, CA
- $90,000 - $180,000 a year
- Full-time
- Engineering
- Office
- Bachelor's degree
- Health insurance
- Tuition reimbursement
Principal Regulatory Affairs Specialist – Diabetes Care (on-site)
Abbott Laboratories —Alameda, CA
- $100,000 - $200,000 a year
- Full-time
- 5 years
- Word processing
- Office
- 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
Principal Regulatory Affairs Specialist - Diabetes Care (on-site)
Abbott Laboratories —Alameda, CA
- $100,000 - $200,000 a year
- Full-time
- 5 years
- Word processing
- Office
- Health insurance
- Tuition reimbursement

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Regulatory Affairs Specialist II

Thermo Fisher Scientific -
Fremont, CA

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Job Details

Full-time
$72,000 - $96,000 a year
12 days ago

Benefits

Commuter assistance
Paid parental leave
Caregiver leave
Employee stock purchase plan
Paid holidays
Disability insurance
Health insurance
Dental insurance
401(k)
Tuition reimbursement
Paid time off
Parental leave
Employee assistance program
Vision insurance
Life insurance

Qualifications

FDA submissions
Technical documentation
GMP
Compliance documentation
Regulatory submission editing and review
Biomedical regulatory compliance
Managing projects
Productivity software
Technical writing experience within technology
Cross-functional collaboration
Information management
ISO 13485
Cross-functional communication
Product lifecycle management

Full Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
Join our team at Thermo Fisher Scientific as a Regulatory Affairs Specialist II, where you'll ensure product compliance and market access for our innovative diagnostic solutions. You'll work with cross-functional teams to manage regulatory submissions, maintain product registrations, and support quality management systems across global markets. This position offers excellent opportunities for professional growth while contributing to our mission of enabling customers to make the world healthier, cleaner, and safer.

Location: Fremont, CA.

Relocation assistance is NOT provided.

REQUIREMENTS:

Advanced Degree with no prior experience, or Bachelor's Degree plus 2 years of experience in regulatory affairs, preferably in IVD/medical device industry
Preferred Fields of Study: Life Sciences, Chemistry, Pharmacy, Engineering, or related scientific field
Additional regulatory affairs certifications beneficial
Comprehensive knowledge of global regulatory requirements, particularly FDA, EU IVDR/MDR, and regional regulations
Strong understanding of quality management systems (ISO 13485, GMP, MDSAP)
Experience preparing and reviewing technical documentation and regulatory submissions
Expertise in product lifecycle management and change control processes
Proven ability to interpret and apply regulatory requirements to product development and maintenance
Excellent project management and organizational skills
Strong analytical and problem-solving capabilities
Superior written and verbal communication skills
Proficiency in Microsoft Office and regulatory information management systems
Ability to work effectively in a matrix organization and cross-functional teams
Detail-oriented with strong documentation skills
Demonstrated ability to manage multiple priorities and meet deadlines
Experience with post-market surveillance and vigilance reporting
Must be legally authorized to work in the United States without sponsorship
Must be able to pass a comprehensive background check, which includes a drug screenin

Compensation and Benefits

The salary range estimated for this position based in California is $72,000.00–$96,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

Apply Now

Refine Your Search

regulatory affairs specialist jobs in uc berkeley ca

Regulatory Affairs Specialist II

Senior Regulatory Affairs Specialist – Lingo (on-site)

Principal Regulatory Affairs Specialist – Diabetes Care (on-site)

Regulatory Affairs Specialist III

Principal Regulatory Affairs Specialist - Diabetes Care (on-site)

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