Regulatory Affairs Specialist Jobs in Exton, 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 (23 miles from Exton, PA)
- 2 days ago
- Fort Washington, PA (23 miles from Exton, PA)
- 2 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...
Regulatory Compliance Specialist
- Wilmington, DE (22 miles from Exton, PA)
- 4 days ago
- Wilmington, DE (22 miles from Exton, PA)
- 4 days ago
Regulatory Compliance Specialist BlueCross BlueShield of South Carolina life insurance, paid time off, tuition assistance, 401(k) United States, Delaware, Wilmington Jun 07, 2025 Summary The...
- West Chester, PA (3 miles from Exton, PA)
- 9 days ago
- West Chester, PA (3 miles from Exton, PA)
- 9 days ago
IT Compliance Analyst Weston Solutions parental leave, 401(k) United States, Pennsylvania, West Chester 1400 Weston Way (Show on map) Jun 03, 2025 Description At Weston Solutions, Inc. you will do...
Product Stewardship and Regulatory Affairs Specialist. Job in Malvern Gr8Jobs
- Malvern, PA (5 miles from Exton, PA)
- 12 days ago
- Malvern, PA (5 miles from Exton, PA)
- 12 days ago
Join a leading company at the forefront of innovation as a Product Stewardship and Regulatory Affairs Specialist....
, 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 (13 miles from Exton, PA)
- 23 days ago
- King of Prussia, PA (13 miles from Exton, 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 (15 miles from Exton, PA)
- 28 days ago
- Audubon, PA (15 miles from Exton, 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 (12 miles from Exton, PA)
- 29 days ago
- Wayne, PA (12 miles from Exton, 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 Work, 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 (13 miles from Exton, PA)
- 30+ days ago
- King of Prussia, PA (13 miles from Exton, 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 (13 miles from Exton, PA)
- 30+ days ago
- King of Prussia, PA (13 miles from Exton, 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 (15 miles from Exton, PA)
- 60+ days ago
- Audubon, PA (15 miles from Exton, 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...
- Wilmington, DE (22 miles from Exton, PA)
- 90+ days ago
- Wilmington, DE (22 miles from Exton, PA)
- 90+ days ago
Maintain internal control standards, including timely and thorough implementation of regulatory and internal audit requirements Participate in various ad hoc projects at a commensurate level of proficiency...
Demographic Data for Exton, PA
Moving to Exton, PA? Find some basic demographic data about Exton, PA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Exton, PA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Exton, 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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