Regulatory Affairs Specialist Jobs in Monroeville, 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.
Sr Government Risk & Compliance Analyst II
- Pittsburgh, PA (7 miles from Monroeville, PA)
- 2 days ago
- Pittsburgh, PA (7 miles from Monroeville, PA)
- 2 days ago
Duquesne Light Company, headquartered in downtown Pittsburgh, is a leader in providing electric energy and has been in the forefront of the electric energy market, with a history rooted in...
Senior Compliance Analyst (MS)
- West Mifflin, PA (7 miles from Monroeville, PA)
- 10 days ago
- West Mifflin, PA (7 miles from Monroeville, PA)
- 10 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 (7 miles from Monroeville, PA)
- 11 days ago
- Pittsburgh, PA (7 miles from Monroeville, PA)
- 11 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...
Compliance Analyst, AML (Anti-Money Laundering)
- West Mifflin, PA (7 miles from Monroeville, PA)
- 25 days ago
- West Mifflin, PA (7 miles from Monroeville, PA)
- 25 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...
/23250/track.gif&z=8&s=QCL&ih_t=5%2F14%2F2025+5%3A00%3A54+PM&utm_medium=internal%20referrer&utm_campaign=bauer-foundation-corporation---ceda-profile&utm_content=bauer-foundation-corporation&utm_term=sf_serp_searchresults_position_5&dt=Desktop)
Regulatory Affairs Coordinator - Pittsburgh, PA
- Pittsburgh, PA (7 miles from Monroeville, PA)
- 30+ days ago
- Pittsburgh, PA (7 miles from Monroeville, PA)
- 30+ days ago
443787BR** **Auto req ID:** 443787BR **Company:** Lanxess **Job Code:** Coordinator Coordinator **Job Description:** On behalf of VetJobs/MilitarySpouseJobs, thank you for your interest. We are...
Regulatory Affairs Coordinator - ON-SITE
- Pittsburgh, PA (7 miles from Monroeville, PA)
- 30+ days ago
- Pittsburgh, PA (7 miles from Monroeville, PA)
- 30+ days ago
Employee Type: Regular Who we are LANXESS is a leading specialty chemicals company with sales of EUR 6.7 billion in 2023. The company currently has about 12,800 employees in 32 countries. Our core...
Regulatory Compliance Specialist - NERC
- Pittsburgh, PA (7 miles from Monroeville, PA)
- 60+ days ago
- Pittsburgh, PA (7 miles from Monroeville, PA)
- 60+ days ago
Regulatory Compliance Specialist - NERC (19070) Requisition ID 19070 - Posted 01/16/2025 - Duquesne Light Company - Legal/Compliance - Corporate 411 Seventh Ave., Pittsburgh, PA 15219 - NonUnion -...
Demographic Data for Monroeville, PA
Moving to Monroeville, PA? Find some basic demographic data about Monroeville, PA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Monroeville, PA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Monroeville, 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
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Resolution
- Microsoft SharePoint
- Product Development
- Risk Management
- Engineering
- Strategy Development
- Process Improvement
- Military Background
- Implementation
- Auditing
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Data Analysis
- Collaboration
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Reporting
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
Other Career Titles
Here are some other career titles that require similar skills
Regulatory Affairs Specialist Related Career Advice Articles
Top Skills and Quality Control Training You Need to Get Promoted
Ready to take your quality control career to the next level? Seek out quality control training for these highly desired skills for quality control jobs.
Read article »