Regulatory Affairs Specialist Jobs in Coatesville, PA
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.
- Universal Health Services
- King of Prussia, PA (24 miles from Coatesville, PA)
- 2 days ago
- King of Prussia, PA (24 miles from Coatesville, PA)
- 2 days ago
Responsibilities (This role has a hybrid schedule with 3 days in office and 2 days flex-remote) Join a dynamic organization driven by our passion for healthcare. UHS is seeking talented...
HybridSr. Specialist Regulatory Affairs, Medical Devices
- West Pharmaceutical Services
- Exton, PA (11 miles from Coatesville, PA)
- 7 days ago
- Exton, PA (11 miles from Coatesville, PA)
- 7 days ago
Systems R.A.C certification(s) License and Certifications Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred Travel Requirements 10%: Up to 26 business days per year Physical...
Hybrid- RevSpring Inc
- Oaks, PA (22 miles from Coatesville, PA)
- 17 days ago
- Oaks, PA (22 miles from Coatesville, PA)
- 17 days ago
IT Audit & Compliance Analyst Position Summary The IT Audit & Compliance Analyst is responsible for driving audit execution and regulatory compliance efforts across the organization, with primary...
In PersonPrincipal Specialist, Regulatory Affairs
- West Pharmaceutical Services
- Exton, PA (11 miles from Coatesville, PA)
- 18 days ago
- Exton, PA (11 miles from Coatesville, PA)
- 18 days ago
(k) device and EU technical documentation submissions....
HybridDemographic Data for Coatesville, PA
Moving to Coatesville, PA? Find some basic demographic data about Coatesville, PA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Coatesville, PA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Coatesville, PA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Filing
- Financial Services
- Reimbursement
- Annuities
- Quality Management Systems
- 21 CFR 820
- Internal Audits
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Continuous Improvement
- Product Development
- Microsoft SharePoint
- Technical Writing
- Analytical Skills
- Risk Management
- Engineering
- Strategy Development
- Auditing
- Military Background
- Written Communication
- Investigation
- Process Improvement
- Documentation
- Implementation
- Verbal Communication
- Reporting
- Policy Development
- Data Analysis
- Education Experience
- Collaboration
- Microsoft PowerPoint
- Bachelor's Degree
- Regulations
- Microsoft Word
- Microsoft Excel
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Time Management
- Leadership
- Communication Skills
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