Regulatory Affairs Specialist Jobs in North Dakota
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.
Senior Compliance Analyst (Risk Assessment and Oversight) - Remote
- Bismarck, ND
- 1 day ago
- Bismarck, ND
- 1 day ago
Our work matters. We help people get the medicine they need to feel better and live well. We do not lose sight of that. It fuels our passion and drives every decision we make. **Job Posting...
Remote Work. + Own audit readiness and guide teams through federal and state exams, internal audits, and testing processes with confidence and clarity. + Turn insights into action by analyzing results, delivering...
Remote WorkSenior Compliance Analyst (Interpretation and Advising) - Remote
- Bismarck, ND
- 4 days ago
- Bismarck, ND
- 4 days ago
Our work matters. We help people get the medicine they need to feel better and live well. We do not lose sight of that. It fuels our passion and drives every decision we make. **Job Posting...
Remote WorkRegulatory Affairs Specialist - Post Market - req1434** **OVERVIEW** Reporting to the Director Regulatory Affairs, the Regulatory Affairs Specialist is responsible for complaint handling, coordination...
Remote WorkSenior Data & Compliance Analyst (2093)** + Title:Senior Data & Compliance Analyst + Group Company: Mitsubishi Chemical America + Location:Remote Group Company: + Mitsubishi Chemical America...
At Everus, employees come first. We provide great pay, benefits and growth opportunities to more than 8,000 highly skilled team members across the country who are united by the common goal of...
Remote WorkDemographic Data for North Dakota
Moving to North Dakota? Find some basic demographic data about North Dakota below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in North Dakota
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in North Dakota 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
- 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
- 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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