Regulatory Affairs Specialist Jobs in Mechanicsburg, 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.
- Harrisburg, PA (7 miles from Mechanicsburg, PA)
- 2 days ago
- Harrisburg, PA (7 miles from Mechanicsburg, PA)
- 2 days ago
Otsuka Pharmaceuticals - Trade Compliance Analyst** **Position Summary:** + Provide technical and analytical support for customs and trade compliance matters at the North Americasite/division(s)...
Sr Regulatory Compliance Specialist
- York, PA (17 miles from Mechanicsburg, PA)
- 5 days ago
- York, PA (17 miles from Mechanicsburg, PA)
- 5 days ago
Rise Baking Company was founded by bakery experts passionate about providing our customers with high quality products and providing a positive, collaborative place to work for our people. We are a...
- Harrisburg, PA (7 miles from Mechanicsburg, PA)
- 8 days ago
- Harrisburg, PA (7 miles from Mechanicsburg, PA)
- 8 days ago
Your Future Evolves Here** Evolent partners with health plans and providers to achieve better outcomes for people with most complex and costly health conditions. Working across specialties and...
- Camp Hill, PA (5 miles from Mechanicsburg, PA)
- 8 days ago
- Camp Hill, PA (5 miles from Mechanicsburg, PA)
- 8 days ago
Reference #: 2525CampHill JOB DESCRIPTION The Regulatory Compliance Analyst is responsible for researching, monitoring, and interpreting Federal, State, and local laws and regulations to support...
Senior Risk & Compliance Analyst
- Harrisburg, PA (7 miles from Mechanicsburg, PA)
- 23 days ago
- Harrisburg, PA (7 miles from Mechanicsburg, PA)
- 23 days ago
LICENSES or CERTIFICATIONS Required None Preferred (any of the following) Certified in Healthcare Compliance (CHC) Certified Healthcare Internal Audit Professional (CHIAP) SKILLS Demonstrate expert...
Information Security Governance, Risk, and Compliance Analyst IV
- Harrisburg, PA (7 miles from Mechanicsburg, PA)
- 45+ days ago
- Harrisburg, PA (7 miles from Mechanicsburg, PA)
- 45+ days ago
Internal Audit Coordination: Coordinate the collection and review of evidence for internal and external audits. Research and respond to internal and external audit finding....
Demographic Data for Mechanicsburg, PA
Moving to Mechanicsburg, PA? Find some basic demographic data about Mechanicsburg, PA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Mechanicsburg, PA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Mechanicsburg, 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
- Medicaid
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Management Reporting
- Fraud Investigation
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Medical Device Sales
- FDA Regulations
- Business Processes
- Document Management
- Microsoft Visio
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Reporting
- Data Analysis
- Education Experience
- Interpersonal Skills
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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