Regulatory Affairs Specialist Jobs in Belcamp, MD
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.
Environmental Compliance Analyst
- Hunt Valley, MD (22 miles from Belcamp, MD)
- 15 hours ago
- Hunt Valley, MD (22 miles from Belcamp, MD)
- 15 hours ago
About Us At EA, you'll find yourself surrounded by dynamic professionals that embrace collaboration and curiosity to foster innovation and problem-solving. This culture forms the essence of our...
- Baltimore, MD (24 miles from Belcamp, MD)
- 1 day ago
- Baltimore, MD (24 miles from Belcamp, MD)
- 1 day ago
Exposure to internal auditing, SOX auditing, or technology auditing. 8. Experience defining attributes and testing IT Controls. 9....
Research Conflict of Interest %26 Conduct Compliance Analyst
- Baltimore, MD (24 miles from Belcamp, MD)
- 12 days ago
- Baltimore, MD (24 miles from Belcamp, MD)
- 12 days ago
The Office of Accountability and Compliance/Conflict of Interest for the University of Maryland, Baltimore (UMB) has an exciting opportunity for Research Conflict of Interest & Conduct Compliance...
Lead Compliance Analyst (Broker-Dealer, Investment Advisor, Insurance Agency)
- Baltimore, MD (24 miles from Belcamp, MD)
- 13 days ago
- Baltimore, MD (24 miles from Belcamp, MD)
- 13 days ago
These are supported by Transamerica Corporate, which includes Finance, People and Places, General Counsel, Risk, Internal Audit, Strategy and Development, and Corporate Affairs, which covers Communications...
Demographic Data for Belcamp, MD
Moving to Belcamp, MD? Find some basic demographic data about Belcamp, MD below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Belcamp, MD
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Belcamp, MD offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Internal Control
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Resolution
- Product Development
- Risk Management
- Affirmative Action
- Engineering
- Strategy Development
- Process Improvement
- Military Background
- Implementation
- Auditing
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Data Analysis
- Collaboration
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Reporting
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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