Regulatory Affairs Specialist Jobs in Etna, 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.
Senior Compliance Analyst, Filings
- West Mifflin, PA (10 miles from Etna, PA)
- 13 days ago
- West Mifflin, PA (10 miles from Etna, PA)
- 13 days ago
The Opportunity: The individual in this position supports supervisors, relationship managers, account owners, and engagement leads with certain ACA managed services offerings including, but not...
- Pittsburgh, PA (10 miles from Etna, PA)
- 21 days ago
- Pittsburgh, PA (10 miles from Etna, PA)
- 21 days ago
Company : Highmark Health Job Description : JOB SUMMARY This job works collaboratively to support of all risk and compliance assessment activities of Highmark Health across a broad range of...
Compliance Analyst (MS), Communication Surveillance
- West Mifflin, PA (10 miles from Etna, PA)
- 28 days ago
- West Mifflin, PA (10 miles from Etna, PA)
- 28 days ago
The Opportunity: In the role of the Compliance Analyst on our Managed Services team, you will be responsible for participating in and ensuring the successful execution of certain compliance...
Senior Risk & Compliance Analyst
- Pittsburgh, PA (10 miles from Etna, PA)
- 30+ days ago
- Pittsburgh, PA (10 miles from Etna, PA)
- 30+ days ago
Company : Highmark Health Job Description : JOB SUMMARY This job works collaboratively to support of all risk and compliance assessment activities of Highmark Health across a broad range of...
Regulatory Affairs Specialist II
- Wexford, PA (10 miles from Etna, PA)
- 30+ days ago
- Wexford, PA (10 miles from Etna, PA)
- 30+ days ago
Experience: Regulatory affairs experience in the In Vitro Diagnostic Medical Device environment, or equivalent Knowledge and application of 21 CFR 820 and ISO 13485 is required Knowledge and application...
Senior Compliance Analyst, AML (Anti-Money Laundering)
- West Mifflin, PA (10 miles from Etna, PA)
- 60+ days ago
- West Mifflin, PA (10 miles from Etna, PA)
- 60+ days ago
The Opportunity: The individual in this position supports supervisors, relationship managers, account owners, and engagement leads with certain ACA managed services offerings including, but not...
- West Mifflin, PA (10 miles from Etna, PA)
- 60+ days ago
- West Mifflin, PA (10 miles from Etna, PA)
- 60+ days ago
The Opportunity: In the role of the Compliance Analyst on our Managed Services team, you will be responsible for participating in and ensuring the successful execution of certain compliance...
Principal Regulatory Affairs Specialist, Robotics (Pittsburgh, PA)
- Pittsburgh, PA (10 miles from Etna, PA)
- 60+ days ago
- Pittsburgh, PA (10 miles from Etna, PA)
- 60+ days ago
Experience with internal/External Audits, Quality Systems expertise and clinical study experience beneficial Experience working with large cross functional teams and diverse groups....
Compliance Analyst, Call Chaperoning
- West Mifflin, PA (10 miles from Etna, PA)
- 60+ days ago
- West Mifflin, PA (10 miles from Etna, PA)
- 60+ days ago
The Opportunity: In the role of the Compliance Analyst on our Managed Services team, you will be responsible for participating in and ensuring the successful execution of certain compliance...
- Pittsburgh, PA (10 miles from Etna, PA)
- 90+ days ago
- Pittsburgh, PA (10 miles from Etna, PA)
- 90+ days ago
audit requests, as well as ad-hoc transaction reviews; Conducts User Acceptance Testing (UAT) for system enhancements and documents work product; Conduct investigations and prepare Suspicious Activity...
Demographic Data for Etna, PA
Moving to Etna, PA? Find some basic demographic data about Etna, PA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Etna, PA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Etna, 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
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- ISO 13485
- Corrective Actions & Preventive Actions
- Business Processes
- Medical Device Sales
- FDA Regulations
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Process Improvement
- Auditing
- Military Background
- Implementation
- Analytical Skills
- Investigation
- Written Communication
- Education Experience
- Verbal Communication
- Documentation
- Data Analysis
- Reporting
- Collaboration
- Filing
- Microsoft PowerPoint
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Sales
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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