Regulatory Affairs Specialist Jobs in West Mifflin, 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.
Basic Qualifications: Minimum 4 years previous work experience in finance and/or accounting Minimum 1 year in accounting or FP&A for a large multi-site business unit Bachelor's degree from an...
Senior Compliance Analyst, AML (Anti-Money Laundering)
- West Mifflin, PA
- 12 days ago
- West Mifflin, PA
- 12 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...
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
- 13 days ago
- Pittsburgh, PA
- 13 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....
International Logistics and Trade Compliance Analyst - Pittsburgh, PA
- Pittsburgh, PA
- 25 days ago
- Pittsburgh, PA
- 25 days ago
Reference #: ...6BackInternational Logistics and Trade Compliance Analyst#25-111Pittsburgh, Pennsylvania, United StatesApplyApply for this job now! ApplyJob DescriptionCompany Profile:Established...
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...
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...
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...
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...
Demographic Data for West Mifflin, PA
Moving to West Mifflin, PA? Find some basic demographic data about West Mifflin, PA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in West Mifflin, PA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in West Mifflin, PA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Medical Device Sales
- Business Processes
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Product Development
- Affirmative Action
- Engineering
- Risk Management
- Military Background
- Analytical Skills
- Implementation
- Auditing
- Investigation
- Verbal Communication
- Writing Skills
- Data Analysis
- Written Communication
- Collaboration
- Documentation
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Sales
- Microsoft Excel
- Microsoft Word
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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