Regulatory Affairs Specialist Jobs in Newark, 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.
- Alameda, CA (21 miles from Newark, CA)
- 4 days ago
- Alameda, CA (21 miles from Newark, CA)
- 4 days ago
The Opportunity As an individual contributor in the function of a Regulatory Affairs Specialist you will provide support for the Regulatory Affairs department to ensure efficient and compliant business...
Regulatory Affairs Specialist I - Heart Failure (on-site)
- Pleasanton, CA (13 miles from Newark, CA)
- 5 days ago
- Pleasanton, CA (13 miles from Newark, CA)
- 5 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 Regulatory Affairs Specialist - Digital Health Technologies (on-site)
- Alameda, CA (21 miles from Newark, CA)
- 13 days ago
- Alameda, CA (21 miles from Newark, CA)
- 13 days ago
The Opportunity As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize new digital products and features including...
Principal Regulatory Affairs Specialist US New Product Introduction Diabetes Care (on-site)
- Alameda, CA (21 miles from Newark, CA)
- 45+ days ago
- Alameda, CA (21 miles from Newark, CA)
- 45+ 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)....
Regulatory Affairs Specialist - Shockwave Medical
- Santa Clara, CA (12 miles from Newark, CA)
- 23 hours ago
- Santa Clara, CA (12 miles from Newark, CA)
- 23 hours ago
Job title Regulatory Affairs Specialist - Shockwave Medical Function Regulatory Affairs Group Sub function Regulatory Affairs Category Analyst, Regulatory Affairs (P4 - E24) Location Santa Clara / United...
Remote Work- San Jose, CA (15 miles from Newark, CA)
- 1 day ago
- San Jose, CA (15 miles from Newark, CA)
- 1 day ago
Our team is looking for Compliance Analysts with experience working in fast-paced and dynamic cloud services organizations, SaaS/PaaS/IaaS, preferably in a compliance role, or engaged in...
- Alameda, CA (21 miles from Newark, CA)
- 1 day ago
- Alameda, CA (21 miles from Newark, CA)
- 1 day ago
Alameda : 1360-1380 South Loop Road ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged...
Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave
- Santa Clara, CA (12 miles from Newark, CA)
- 1 day ago
- Santa Clara, CA (12 miles from Newark, CA)
- 1 day ago
Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave- Function Regulatory Affairs Group- Sub function Regulatory Affairs- Category Experienced Analyst, Regulatory Affairs (P5)- Location...
Remote WorkRegulatory Affairs Specialist 2
- Sunnyvale, CA (9 miles from Newark, CA)
- 2 days ago
- Sunnyvale, CA (9 miles from Newark, CA)
- 2 days ago
Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the...
Senior Regulatory Affairs Specialist - Lingo (on-site)
- Alameda, CA (21 miles from Newark, CA)
- 3 days ago
- Alameda, CA (21 miles from Newark, CA)
- 3 days ago
Alameda : 2901 Harbor Bay Parkway ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged...
Sr Regulatory Affairs Specialist - Shockwave
- Santa Clara, CA (12 miles from Newark, CA)
- 4 days ago
- Santa Clara, CA (12 miles from Newark, CA)
- 4 days ago
Job title Sr Regulatory Affairs Specialist - Shockwave Function Regulatory Affairs Group Sub function Regulatory Affairs Category Experienced Analyst, Regulatory Affairs (P5) Location Santa Clara /...
Remote WorkSenior Regulatory Affairs Specialist - Lingo (on-site)
- Alameda, CA (21 miles from Newark, CA)
- 5 days ago
- Alameda, CA (21 miles from Newark, CA)
- 5 days ago
As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize products in the US on-site at our Alameda, CA location...
Regulatory Affairs Specialist Mandarin Speaking
- Sunnyvale, CA (9 miles from Newark, CA)
- 5 days ago
- Sunnyvale, CA (9 miles from Newark, CA)
- 5 days ago
Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the...
- San Jose, CA (15 miles from Newark, CA)
- 8 days ago
- San Jose, CA (15 miles from Newark, CA)
- 8 days ago
Insight Global is looking for a Compliance Analyst to work remote for an enterprise cloud and security organization. This person will be responsible for ensuring annual cloud and security...
Awareness of the FDA regulations Experience with Microsoft Office Suite (Word, Excel, PowerPoint, Office), Word Templates and Adobe Professional....
Demographic Data for Newark, CA
Moving to Newark, CA? Find some basic demographic data about Newark, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Newark, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Newark, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Medical Device Sales
- Business Processes
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Product Development
- Affirmative Action
- Engineering
- Risk Management
- Military Background
- Analytical Skills
- Implementation
- Auditing
- Investigation
- Verbal Communication
- Writing Skills
- Data Analysis
- Written Communication
- Collaboration
- Documentation
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Sales
- Microsoft Excel
- Microsoft Word
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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