Regulatory Affairs Specialist Jobs in Coopersburg, 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.
Trade Compliance Analyst (Contract Role)
- Colmar, PA (16 miles from Coopersburg, PA)
- 4 days ago
- Colmar, PA (16 miles from Coopersburg, PA)
- 4 days ago
Dorman was founded on the belief that people should have greater freedom to fix motor vehicles. For over 100 years, we have been driving new solutions, releasing tens of thousands of aftermarket...
Regulatory Compliance Specialist in Bethlehem,PA,US
- Bethlehem, PA (6 miles from Coopersburg, PA)
- 11 days ago
- Bethlehem, PA (6 miles from Coopersburg, PA)
- 11 days ago
Support third-party regulatory, customer, and internal audits by organizing, maintaining, and presenting necessary documentation....
- Audubon, PA (23 miles from Coopersburg, PA)
- 28 days ago
- Audubon, PA (23 miles from Coopersburg, PA)
- 28 days ago
Flexible Work Arrangement: Hybrid**** **The **Sr. (Lead) Compliance Analyst** is responsible to ensure, through a team of business owners and subject matter experts, that PJM continually adheres...
Sr Regulatory Affairs Specialist
- Audubon, PA (23 miles from Coopersburg, PA)
- 60+ days ago
- Audubon, PA (23 miles from Coopersburg, PA)
- 60+ days ago
At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these...
- Easton, PA (18 miles from Coopersburg, PA)
- 60+ days ago
- Easton, PA (18 miles from Coopersburg, PA)
- 60+ days ago
Scope: The Senior Trade Compliance Analyst is responsible for supporting and assisting export and/or import activities with oversight and direction from the Global Trade Compliance Manager....
Demographic Data for Coopersburg, PA
Moving to Coopersburg, PA? Find some basic demographic data about Coopersburg, PA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Coopersburg, PA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Coopersburg, PA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- 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
- Interpersonal Skills
- 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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