Regulatory Affairs Specialist Jobs in Fairfield, ME
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.
- Augusta, ME (20 miles from Fairfield, ME)
- 1 day ago
- Augusta, ME (20 miles from Fairfield, ME)
- 1 day ago
Otsuka Pharmaceuticals - Trade Compliance Analyst** **Position Summary:** + Provide technical and analytical support for customs and trade compliance matters at the North Americasite/division(s)...
- Augusta, ME (20 miles from Fairfield, ME)
- 8 days ago
- Augusta, ME (20 miles from Fairfield, ME)
- 8 days ago
at Evolent in Augusta, Maine, United States Job Description Your Future Evolves Here Evolent partners with health plans and providers to achieve better outcomes for people with most complex and...
Regulatory Compliance Specialist
- Augusta, ME (20 miles from Fairfield, ME)
- 10 days ago
- Augusta, ME (20 miles from Fairfield, ME)
- 10 days ago
at Oracle in Augusta, Maine, United States Job Description Job Description Primary responsibilities and functions include: + Serves as subject matter expert with regard to compliance operations...
Senior Risk & Compliance Analyst
- Augusta, ME (20 miles from Fairfield, ME)
- 22 days ago
- Augusta, ME (20 miles from Fairfield, ME)
- 22 days ago
at Highmark Health in Augusta, Maine, United States Job Description Company : Highmark Health Job Description : JOB SUMMARY This is a Hybrid role and will require you to be onsite at either our...
Demographic Data for Fairfield, ME
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Fairfield, ME
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Fairfield, ME offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Medicaid
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Management Reporting
- Fraud Investigation
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Medical Device Sales
- FDA Regulations
- Business Processes
- Document Management
- Microsoft Visio
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Reporting
- Data Analysis
- Education Experience
- Interpersonal Skills
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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