Regulatory Affairs Specialist Jobs in Imperial, 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.
- Pittsburgh, PA (21 miles from Imperial, PA)
- 1 day ago
- Pittsburgh, PA (21 miles from Imperial, PA)
- 1 day ago
eNGINE builds Technical Teams. We are a Solutions and Placement firm shaped by decades of interaction with Technical professionals. Our inspiration is continuous learning and engagement with the...
Senior Regulatory Affairs Specialist (Memphis, TN)
- Pittsburgh, PA (21 miles from Imperial, PA)
- 1 day ago
- Pittsburgh, PA (21 miles from Imperial, PA)
- 1 day ago
We're looking for a Regulatory Affairs Specialist to join our team and drive regulatory strategies for our cutting-edge products. If you're ready to make an impact, apply now!...
- Bellevue, PA (11 miles from Imperial, PA)
- 1 day ago
- Bellevue, PA (11 miles from Imperial, PA)
- 1 day ago
Job Description The Leave and Compliance Analyst is responsible for administering and managing employee leaves of absence, accommodation requests, worker's compensation claims, and ensuring...
Senior Risk & Compliance Analyst
- Pittsburgh, PA (21 miles from Imperial, PA)
- 2 days ago
- Pittsburgh, PA (21 miles from Imperial, PA)
- 2 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 (16 miles from Imperial, PA)
- 3 days ago
- Wexford, PA (16 miles from Imperial, PA)
- 3 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 (21 miles from Imperial, PA)
- 30+ days ago
- West Mifflin, PA (21 miles from Imperial, PA)
- 30+ 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 (21 miles from Imperial, PA)
- 30+ days ago
- West Mifflin, PA (21 miles from Imperial, PA)
- 30+ 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 (21 miles from Imperial, PA)
- 30+ days ago
- Pittsburgh, PA (21 miles from Imperial, PA)
- 30+ 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 (21 miles from Imperial, PA)
- 30+ days ago
- Pittsburgh, PA (21 miles from Imperial, PA)
- 30+ days ago
Reference #: ...6BackInternational Logistics and Trade Compliance Analyst#25-111Pittsburgh, Pennsylvania, United StatesApplyApply for this job now! ApplyJob DescriptionCompany Profile:Established...
- West Mifflin, PA (21 miles from Imperial, PA)
- 45+ days ago
- West Mifflin, PA (21 miles from Imperial, PA)
- 45+ 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 (21 miles from Imperial, PA)
- 60+ days ago
- Pittsburgh, PA (21 miles from Imperial, PA)
- 60+ 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...
Regulatory Affairs Coordinator - ON-SITE
- Pittsburgh, PA (21 miles from Imperial, PA)
- 60+ days ago
- Pittsburgh, PA (21 miles from Imperial, PA)
- 60+ 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...
Demographic Data for Imperial, PA
Moving to Imperial, PA? Find some basic demographic data about Imperial, PA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Imperial, PA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Imperial, PA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Vendor Management
- Reimbursement
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- Microsoft Visio
- FDA Regulations
- Business Analysis
- Standard Operating Procedures
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- High School Diploma
- Investigation
- Written Communication
- Verbal Communication
- Data Analysis
- Education Experience
- Collaboration
- Documentation
- Reporting
- Filing
- Regulations
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Time Management
- 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 »