Manager of Regulatory Affairs Jobs in Arkansas
A Manager of Regulatory Affairs in the quality control industry plays a pivotal role in ensuring that the company's products meet all necessary regulatory standards. Their key responsibilities include developing and implementing regulatory strategies, monitoring changes to regulatory guidelines, and ensuring the organization's compliance with these changes. They also engage in the preparation, review, and submission of regulatory documents to regulatory agencies. To effectively execute these responsibilities, they liaise with various stakeholders within and outside the organization, such as product developers, project managers, and regulatory bodies.
Important skills and certifications for a Manager of Regulatory Affairs include strong organizational and project management skills, excellent written and verbal communication skills, as well as a keen eye for detail. Analytical thinking and problem-solving skills are also crucial in this role. Additionally, they should possess relevant certifications such as the Regulatory Affairs Certification (RAC), which is recognized worldwide as the leading credential for regulatory professionals in the healthcare product sector. Before becoming a Manager of Regulatory Affairs, a person may have roles such as a Regulatory Affairs Specialist, Quality Control Analyst, or a Quality Assurance Associate. These roles would provide the necessary exposure and experience in quality control and regulatory affairs needed for the managerial position.
Principal Scientist (Director) - Regulatory Affairs-CMC
- Little Rock, AR
- 3 days ago
- Little Rock, AR
- 3 days ago
**Director, Combination Product Regulatory CMC - (R5)** This Principal Scientist position is equivalent to a Director position. Under direction from the Combination Product Regulatory CMC Team...
Associate Principal Scientist/Associate Director , Regulatory Affairs - Compliance
- Little Rock, AR
- 7 days ago
- Little Rock, AR
- 7 days ago
systems against ISO 13485, MDSAP, EU MDR, EU IVDR and other global device regulations. + Experience obtaining CE Marking for Medical Devices and Notified Body Opinion (NBOp) for drug delivery combination...
regulations, including 21 CFR 1271 and 21 CFR 312 **Job Location** This role is located onsite in our Eden Prairie, MN (Miromatrix) location with the option for a remote candidate with monthly travel...
Posting End Date:** **Work Place Flexibility:** Hybrid *****The preferred location for this position is Austin, TX. Qualified candidates within Entergys service territory may be considered in...
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Salary for Manager of Regulatory Affairs Jobs in Arkansas
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in Arkansas offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Regulatory Affairs position
- Molecular Biology
- Biochemistry
- Data Management
- Process Development
- Biology
- Immunology
- Hazardous Materials
- Medical Writing
- Scientific Writing
- Drug Development
- Gene Therapy
- Quality Systems
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- GxP
- ISO 13485
- Quality Management
- Electrical Engineering
- Control Systems
- Document Control
- Inspections
- Medical Device Sales
- Microbiology
- FDA Regulations
- Research and Development
- Diagnostic
- Product Development
- Affirmative Action
- Engineering
- Strategy Development
- Quality Assurance
- Auditing
- Implementation
- Written Communication
- Mentoring
- Employee Development
- Collaboration
- Documentation
- Reporting
- Coaching
- Regulations
- Policy Development
- English
- Project Management
- Problem Solving
- Team Building
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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