Regulatory Affairs Specialist Jobs
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.
- Computech Corporation
- Cumberland, RI
- 2 days ago
- Computech Corporation
- Cumberland, RI
- 2 days ago
Job Title: Analyst I - Compliance Job Location:200 Highland Corporate Drive, Cumberland, RI, USA, 02864, Monday - Friday (Hybrid Wednesday in office) RI preferred, AZ accepted Schedule Hours:...
Our client, a leading financial institution, is seeking a Senior Compliance Analyst to join their team. As a Senior Compliance Analyst, you will be part of the Compliance Department supporting key...
Ready to be pushed beyond what you think you're capable of? At Coinbase, our mission is to increase economic freedom in the world. It's a massive, ambitious opportunity that demands the best of...
Ready to be pushed beyond what you think you're capable of? At Coinbase, our mission is to increase economic freedom in the world. It's a massive, ambitious opportunity that demands the best of...
Ready to be pushed beyond what you think you're capable of? At Coinbase, our mission is to increase economic freedom in the world. It's a massive, ambitious opportunity that demands the best of...
Ready to be pushed beyond what you think you're capable of? At Coinbase, our mission is to increase economic freedom in the world. It's a massive, ambitious opportunity that demands the best of...
Ready to be pushed beyond what you think you're capable of? At Coinbase, our mission is to increase economic freedom in the world. It's a massive, ambitious opportunity that demands the best of...
Sr Digital Security & Compliance Analyst Job ID 217637 Posted 19-May-2025 Service line Advisory Segment Role type Full-time Areas of Interest Accounting/Finance, Digital & Technology/Information...
Job Description BAE Systems is offering a unique opportunity for the right candidate to work in the NATO SEASPARROW Project Office (NSPO) in Arlington, VA, which is the largest Interantional...
Job Description Summary Regulatory Affairs Specialist I, Hybrid - in office 4 days (Covington, GA) Urology and Critical Care (UCC) is an established and trusted partner in urinary healthcare, developing...
Global Regulatory Affairs, Associate Director - UK Regulations Focus (London, UK) #4132
- Washington, DC
- 4 hours ago
- Washington, DC
- 4 hours ago
Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective...
Job Responsibilities Who we are: At the South Carolina Department of Revenue (SCDOR), we are funding a better state to live, work, and play. Offering excellent benefits, hybrid work schedules,...
About NetApp NetApp is the intelligent data infrastructure company, turning a world of disruption into opportunity for every customer. No matter the data type, workload or environment, we help our...
A Day in the Life We are seeking a Senior Regulatory Affairs Specialist to join our team within Medtronic Acute Care and Monitoring (ACM)....
The Senior Regulatory Affairs Specialist develops strategies for worldwide product registration with global regulatory agencies to introduce Cardiac Ablation Solution devices to market, provides advice...
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs Nationwide
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Reimbursement
- Internal Audits
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Continuous Improvement
- Product Development
- Engineering
- Risk Management
- Military Background
- Analytical Skills
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Writing Skills
- Data Analysis
- Collaboration
- Documentation
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Microsoft Word
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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