Manager of Regulatory Affairs Jobs in Ohio
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.
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...
HR Control Manager - Regulatory Affairs - Vice President
- Columbus, OH
- 8 days ago
- Columbus, OH
- 8 days ago
JobID: 210574564 Category: Control Officers JobSchedule: Full time Posted Date: 2025-06-04T14:44:16+00:00 JobShift: Day Base Pay/Salary: Jersey City,NJ $118,750.00-$190,000.00 Join our HR Control...
Develop, implement and coordinate compliance with federal, state, local and international regulatory requirements applicable to Institution cleaning chemicals, equipment, water-based coatings and...
What Regulatory Affairs Business Liaison contributes to Cardinal Health This function applies subject matter expertise regarding technical, clinical and manufacturing regulatory processes and...
It's fun to work in a company where people truly BELIEVE in what they are doing! We're committed to bringing passion and customer focus to the business. Regulatory Compliance: * Stay updated on...
Summary: The Manager of Regulatory Affairs is responsible for leading the overall regulatory affairs functions at Invacare....
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Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
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Manager of Regulatory Affairss in Ohio offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Regulatory Affairs position
- Clinical Research
- Biochemistry
- Biology
- Immunology
- Assay Development
- Medical Writing
- Scientific Writing
- Drug Development
- Clinical Trials
- Drug Discovery
- Toxicology
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- ICH GCP
- Internal Audits
- Quality Management Systems
- Quality Systems
- Supplier Auditing
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- GxP
- Change Control
- Medical Device Sales
- Microbiology
- Document Management
- FDA Regulations
- Research and Development
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Process Improvement
- Quality Assurance
- Implementation
- Auditing
- Verbal Communication
- Written Communication
- Mentoring
- Collaboration
- Documentation
- Coaching
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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