Regulatory Affairs Specialist Jobs in Fremont, CA
The Director of Regulatory Affairs in the quality control industry plays an essential role in ensuring that the company's products meet all regulatory standards and compliance requirements. This individual oversees the development and implementation of regulatory strategies for new and existing products, supervises the preparation of regulatory submissions, and maintains communication with regulatory authorities. They also monitor changes in regulations, interpret these updates for relevant departments within the company, and implement necessary changes to maintain compliance. They are responsible for setting the company's standards for quality, safety, and efficacy.
To excel in this role, one should possess excellent analytical skills, strategic thinking, and strong leadership abilities. A deep understanding of regulatory guidelines, ability to interpret complex regulations, and excellent communication skills are essential. They should have a degree in a relevant field, along with certifications such as Regulatory Affairs Certification (RAC), Certified Quality Auditor (CQA), and Certified Quality Engineer (CQE). Prior to becoming a Director of Regulatory Affairs, individuals might have roles such as Regulatory Affairs Specialist, Regulatory Affairs Manager, or Quality Control Manager.
Regulatory Affairs Specialist I - Heart Failure (on-site)
- Pleasanton, CA (9 miles from Fremont, CA)
- 3 days ago
- Pleasanton, CA (9 miles from Fremont, CA)
- 3 days ago
Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements...
Senior Specialist Regulatory Affairs
- Alameda, CA (21 miles from Fremont, CA)
- 10 days ago
- Alameda, CA (21 miles from Fremont, CA)
- 10 days ago
Regulatory Affairs Specialist, you will provide support to the Regulatory Affairs department to ensure efficient and compliant business processes and environment are followed....
Regulatory Affairs Specialist II - Heart Failure
- Pleasanton, CA (9 miles from Fremont, CA)
- 13 hours ago
- Pleasanton, CA (9 miles from Fremont, CA)
- 13 hours ago
This Regulatory Affairs Specialist II will work out of our Pleasanton, CA location in our Heart Failure Division....
Regulatory Affairs Specialist I - Heart Failure (on-site)
- Pleasanton, CA (9 miles from Fremont, CA)
- 2 days ago
- Pleasanton, CA (9 miles from Fremont, CA)
- 2 days ago
Pleasanton : 6101 Stoneridge Dr ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Awkward/forceful/repetitive (arms...
Regulatory Affairs Specialist II
- Alameda, CA (21 miles from Fremont, CA)
- 2 days ago
- Alameda, CA (21 miles from Fremont, CA)
- 2 days ago
., Instructions for Use and product labels) Understand the Quality System regulations (ISO 13485), Design Control, and regional Regulatory requirements....
- Santa Clara, CA (14 miles from Fremont, CA)
- 2 days ago
- Santa Clara, CA (14 miles from Fremont, CA)
- 2 days ago
Job Title: Associate Regulatory Affairs Specialist, Operations Looking for an entry level candidate looking to gain experience in Regulatory Affairs, NO EXPERIENCE NEEDED....
Sr Regulatory Operations Specialist (Remote) - Shockwave
- Santa Clara, CA (14 miles from Fremont, CA)
- 3 days ago
- Santa Clara, CA (14 miles from Fremont, CA)
- 3 days ago
The function of the Senior Regulatory Affairs Specialist, Operations, includes providing submission publishing/verification support and Regulatory compliance support....
Remote WorkSr Regulatory Affairs Specialist (Remote) - Shockwave
- Santa Clara, CA (14 miles from Fremont, CA)
- 3 days ago
- Santa Clara, CA (14 miles from Fremont, CA)
- 3 days ago
J&J Family of Companies Sr Regulatory Affairs Specialist (Remote) - Shockwave in Santa Clara , California At Johnson & Johnson,we believe health is everything....
Remote Work- Oakland, CA (19 miles from Fremont, CA)
- 3 days ago
- Oakland, CA (19 miles from Fremont, CA)
- 3 days ago
Pay rate range:$40-45/hr. Job Descriptions: Candidates must be local to work location/Bay Area and will be required in office 1-2 times per month at Oakland General Office. Client laptop, monitor,...
- Oakland, CA (19 miles from Fremont, CA)
- 4 days ago
- Oakland, CA (19 miles from Fremont, CA)
- 4 days ago
Candidates must be local to work location/Bay Area and will be required in office 1-2 times per month at Oakland General Office. PG&E laptop, monitor, docking station, mouse, and keyboard will be...
Trade Compliance Analyst - INTL - India
- Milpitas, CA (13 miles from Fremont, CA)
- 6 days ago
- Milpitas, CA (13 miles from Fremont, CA)
- 6 days ago
Insight Global Trade Compliance Analyst - INTL - India in Milpitas , California Job Description Trade compliance analyst who will play a key role in ensuring our organization's adherence to trade...
- San Jose, CA (16 miles from Fremont, CA)
- 7 days ago
- San Jose, CA (16 miles from Fremont, CA)
- 7 days ago
Description Purpose Responsible for regulatory affairs activities to assist in regulatory submission, registrations and listings. Assure compliance with applicable medical device regulations per...
- Pleasanton, CA (9 miles from Fremont, CA)
- 9 days ago
- Pleasanton, CA (9 miles from Fremont, CA)
- 9 days ago
About the company Albertsons Companies is at the forefront of the revolution in retail. With a fixation on raising the bar with innovation and building belonging through our culture, our team is...
Associate Regulatory Affairs Specialist, Operations
- Santa Clara, CA (14 miles from Fremont, CA)
- 15 days ago
- Santa Clara, CA (14 miles from Fremont, CA)
- 15 days ago
Job Title: Associate Regulatory Affairs Specialist, Operations Job Description The Associate Regulatory Affairs Operations Specialist will help secure and retain global regulatory approvals for medical...
Principal Regulatory Affairs Specialist - Heart Failure (on-site)
- Pleasanton, CA (9 miles from Fremont, CA)
- 15 days ago
- Pleasanton, CA (9 miles from Fremont, CA)
- 15 days ago
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)....
Demographic Data for Fremont, CA
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Fremont, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Fremont, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Analytical Skills
- Filing
- Financial Services
- Mortgage Processing
- Reimbursement
- Juris Doctor
- Internal Audits
- Quality Systems
- 21 CFR 820
- ISO 9001
- ICH Guidelines
- ISO 13485
- ISO 14001
- Quality Management
- Process Controls
- Medical Device Sales
- Business Processes
- FDA Regulations
- Microsoft Visio
- Standard Operating Procedures
- Engineering
- Product Development
- Affirmative Action
- Risk Management
- Quality Assurance
- Process Improvement
- Implementation
- Military Background
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Time Management
- Teamwork
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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