Regulatory Affairs Specialist Jobs in Souderton, 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 Compliance Analyst- Originations
- Fort Washington, PA (12 miles from Souderton, PA)
- 3 days ago
- Fort Washington, PA (12 miles from Souderton, PA)
- 3 days ago
Exceed the expectations of our residential mortgage borrowers & business partners through superior service, simple processes, and effective communications. We deliver on this mission by empowering...
Trade Compliance Analyst (Contract Role)
- Colmar, PA (4 miles from Souderton, PA)
- 3 days ago
- Colmar, PA (4 miles from Souderton, PA)
- 3 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 (20 miles from Souderton, PA)
- 11 days ago
- Bethlehem, PA (20 miles from Souderton, PA)
- 11 days ago
Support third-party regulatory, customer, and internal audits by organizing, maintaining, and presenting necessary documentation....
Product Stewardship and Regulatory Affairs Specialist. Job in Malvern Gr8Jobs
- Malvern, PA (20 miles from Souderton, PA)
- 12 days ago
- Malvern, PA (20 miles from Souderton, PA)
- 12 days ago
Join a leading company at the forefront of innovation as a Product Stewardship and Regulatory Affairs Specialist....
Senior Specialist, Regulatory Affairs - Medical Device
- Exton, PA (24 miles from Souderton, PA)
- 15 days ago
- Exton, PA (24 miles from Souderton, PA)
- 15 days ago
, Skills and Abilities Advanced knowledge of ISO 13485 Attention to detail with planning, time management and organizational skills Regulatory compliance competency including Quality Systems Experience...
Regulatory Compliance Specialist
- King of Prussia, PA (14 miles from Souderton, PA)
- 23 days ago
- King of Prussia, PA (14 miles from Souderton, PA)
- 23 days ago
Company Description Clean Earth is a leading provider of environmental services in the United States providing remediation, disposal, recycling, and beneficial reuse solutions for hazardous and...
- Audubon, PA (10 miles from Souderton, PA)
- 28 days ago
- Audubon, PA (10 miles from Souderton, 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...
- Wayne, PA (16 miles from Souderton, PA)
- 29 days ago
- Wayne, PA (16 miles from Souderton, PA)
- 29 days ago
Please read - the annual compensation range for this position is $90 - 93K. Open to fully remote candidates in the Eastern Time Zone or hybrid near the Greater Philadelphia area. Interested in a...
Remote WorkSenior Specialist, Regulatory Affairs
- Exton, PA (24 miles from Souderton, PA)
- 30+ days ago
- Exton, PA (24 miles from Souderton, PA)
- 30+ days ago
, Skills and Abilities Advanced knowledge of ISO 13485 Attention to detail with planning, time management and organizational skills Regulatory compliance competency including Quality Systems Experience...
Sr SOX Compliance Analyst - Business Process
- King of Prussia, PA (14 miles from Souderton, PA)
- 30+ days ago
- King of Prussia, PA (14 miles from Souderton, PA)
- 30+ days ago
Requistion Number: 26259 When you work for AmeriGas, you become a part of something BIG! Founded in 1959, AmeriGas is the nations premiere propane company, serving over 1.5 million residential,...
Global Senior Governance, Risk, and Compliance Analyst
- King of Prussia, PA (14 miles from Souderton, PA)
- 30+ days ago
- King of Prussia, PA (14 miles from Souderton, PA)
- 30+ days ago
Requistion Number: 26210 When you work for AmeriGas, you become a part of something BIG! Founded in 1959, AmeriGas is the nations premiere propane company, serving over 1.5 million residential,...
Sr Regulatory Affairs Specialist
- Audubon, PA (10 miles from Souderton, PA)
- 60+ days ago
- Audubon, PA (10 miles from Souderton, 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...
Demographic Data for Souderton, PA
Moving to Souderton, PA? Find some basic demographic data about Souderton, PA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Souderton, PA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Souderton, 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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