Regulatory Affairs Specialist Jobs in Morgan Hill, 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.
- San Jose, CA (18 miles from Morgan Hill, CA)
- 1 day ago
- San Jose, CA (18 miles from Morgan Hill, 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...
Regulatory Affairs Coordinator
- Watsonville, CA (16 miles from Morgan Hill, CA)
- 2 days ago
- Watsonville, CA (16 miles from Morgan Hill, CA)
- 2 days ago
POSITION SUMMARY At Nordic Naturals, we take pride in crafting foundational nutrients to help people all over the world live healthy lives. Our mission is to give people, pets, and families the...
Cybersecurity Risk and Compliance Analyst
- Santa Clara, CA (21 miles from Morgan Hill, CA)
- 3 days ago
- Santa Clara, CA (21 miles from Morgan Hill, CA)
- 3 days ago
About Marvell Marvells semiconductor solutions are the essential building blocks of the data infrastructure that connects our world. Across enterprise, cloud and AI, automotive, and carrier...
Compliance Analyst (Canadian CCCS)
- San Jose, CA (18 miles from Morgan Hill, CA)
- 3 days ago
- San Jose, CA (18 miles from Morgan Hill, CA)
- 3 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...
Staff Regulatory Affairs Specialist - Hybrid
- Milpitas, CA (20 miles from Morgan Hill, CA)
- 5 days ago
- Milpitas, CA (20 miles from Morgan Hill, CA)
- 5 days ago
Job Overview The Staff Regulatory Affairs Specialist is part of the team responsible for Core Business New Product Development with a focus on compliance to regulations from the US Food Drug & Administration...
Regulatory Compliance Specialist
- Livermore, CA (23 miles from Morgan Hill, CA)
- 13 days ago
- Livermore, CA (23 miles from Morgan Hill, CA)
- 13 days ago
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses...
- Santa Clara, CA (21 miles from Morgan Hill, CA)
- 17 days ago
- Santa Clara, CA (21 miles from Morgan Hill, CA)
- 17 days ago
Regulatory Affairs Associate#25-54412 $43.72 per hour Santa Clara, CA All On-site Job Description Responsible for filing necessary applications and handling all government interactions pertaining...
- Santa Clara, CA (21 miles from Morgan Hill, CA)
- 17 days ago
- Santa Clara, CA (21 miles from Morgan Hill, CA)
- 17 days ago
Driving quality system process improvement initiatives Initiatives include but are not limited to: Establishing emerging issues in our quality system, Maintaining the quality system procedures (e.g....
- Santa Clara, CA (21 miles from Morgan Hill, CA)
- 18 days ago
- Santa Clara, CA (21 miles from Morgan Hill, CA)
- 18 days ago
Device Regulatory Affairs Associate Regulatory Affairs Regulatory Regulatory Affairs Specialist Quality Compliance CAPA change management change order FDA Biotechnology Pharmaceuticals Medical Device...
Sr Regulatory Affairs Specialist
- Campbell, CA (19 miles from Morgan Hill, CA)
- 25 days ago
- Campbell, CA (19 miles from Morgan Hill, CA)
- 25 days ago
Title: Sr Regulatory Affairs Specialist This position is based in our Campbell, California offices. This position is on-site, full-time. Why Imperative Care?...
- San Jose, CA (18 miles from Morgan Hill, CA)
- 45+ days ago
- San Jose, CA (18 miles from Morgan Hill, CA)
- 45+ days ago
Job Req ID: 26084 About Supermicro: Supermicro is a Top Tier provider of advanced server, storage, and networking solutions for Data Center, Cloud Computing, Enterprise IT, Hadoop/ Big Data,...
Regulatory Affairs Specialist I
- San Jose, CA (18 miles from Morgan Hill, CA)
- 45+ days ago
- San Jose, CA (18 miles from Morgan Hill, CA)
- 45+ days ago
Regulatory Affairs Specialist I Department: Quality Employment Type: Full Time Location: US-California-San Jose Compensation: $118,100 - $138,600 / year Description The Sr....
Demographic Data for Morgan Hill, CA
Moving to Morgan Hill, CA? Find some basic demographic data about Morgan Hill, CA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Morgan Hill, CA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Morgan Hill, CA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Medicaid
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Management Reporting
- Fraud Investigation
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Medical Device Sales
- FDA Regulations
- Business Processes
- Document Management
- Microsoft Visio
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Reporting
- Data Analysis
- Education Experience
- Interpersonal Skills
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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