Regulatory Affairs Specialist Jobs in Harleysville, 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.
Compliance Analyst, Specialist
- Malvern, PA (17 miles from Harleysville, PA)
- 7 hours ago
- Malvern, PA (17 miles from Harleysville, PA)
- 7 hours ago
Are you excited by the opportunity to help shape something new, while being supported by a team of experienced peers? Vanguard's Cash+ Program is a first-of-its-kind offer, and we're looking for a...
Remote Retirement Plan Compliance Analyst
- Dresher, PA (15 miles from Harleysville, PA)
- 19 days ago
- Dresher, PA (15 miles from Harleysville, PA)
- 19 days ago
FuturePlan is the nation's largest third-party administrator (TPA) of retirement plans, partnering with advisors in all 50 states. FuturePlan delivers the best of both worlds: high-touch...
Remote WorkSr Product Stewardship & Regulatory Affairs Specialist Job
- Radnor, PA (14 miles from Harleysville, PA)
- 23 days ago
- Radnor, PA (14 miles from Harleysville, PA)
- 23 days ago
In conjunction with the Specialty Surfactants Business Unit (BU) for which the position is responsible, manage activities to assure compliance with legal and corporate product stewardship and...
Global Senior Governance, Risk, and Compliance Analyst (King Of Prussia, PA, US, 19406)
- King of Prussia, PA (12 miles from Harleysville, PA)
- 25 days ago
- King of Prussia, PA (12 miles from Harleysville, PA)
- 25 days ago
Requistion Number: 26210 When you work for AmeriGas, you become a part of something BIG! Founded in 1959, AmeriGas is the nation's premiere propane company, serving over 1.5 million residential,...
Sr SOX Compliance Analyst - Business Process (King Of Prussia, PA, US, 19406)
- King of Prussia, PA (12 miles from Harleysville, PA)
- 25 days ago
- King of Prussia, PA (12 miles from Harleysville, PA)
- 25 days ago
Requistion Number: 26259 When you work for AmeriGas, you become a part of something BIG! Founded in 1959, AmeriGas is the nation's premiere propane company, serving over 1.5 million residential,...
Regulatory Compliance Specialist II
- Allentown, PA (23 miles from Harleysville, PA)
- 30+ days ago
- Allentown, PA (23 miles from Harleysville, PA)
- 30+ days ago
Regulatory Compliance Specialist II Allentown, Pennsylvania, United States | Posted: 6/24/2025 Indotronix is an Equal Opportunity Employer Let Us Do the Heavy Lifting! Upload your resume and we'll...
Compliance Analyst- HMDA Originations
- Fort Washington, PA (13 miles from Harleysville, PA)
- 30+ days ago
- Fort Washington, PA (13 miles from Harleysville, PA)
- 30+ 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...
- Newtown Square, PA (19 miles from Harleysville, PA)
- 30+ days ago
- Newtown Square, PA (19 miles from Harleysville, PA)
- 30+ days ago
Role Overview; This position sits within the Compliance Department. ;It will have a focus on communication, engagement and strategy. ; Heavy SharePoint usage and involvement with the budget and...
Sr Compliance Analyst- Originations
- Fort Washington, PA (13 miles from Harleysville, PA)
- 45+ days ago
- Fort Washington, PA (13 miles from Harleysville, PA)
- 45+ 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...
Senior Specialist, Regulatory Affairs - Medical Device
- Exton, PA (20 miles from Harleysville, PA)
- 60+ days ago
- Exton, PA (20 miles from Harleysville, PA)
- 60+ 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...
Senior Specialist, Regulatory Affairs
- Exton, PA (20 miles from Harleysville, PA)
- 60+ days ago
- Exton, PA (20 miles from Harleysville, PA)
- 60+ 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 (12 miles from Harleysville, PA)
- 60+ days ago
- King of Prussia, PA (12 miles from Harleysville, PA)
- 60+ 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 (12 miles from Harleysville, PA)
- 60+ days ago
- King of Prussia, PA (12 miles from Harleysville, PA)
- 60+ 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 (8 miles from Harleysville, PA)
- 90+ days ago
- Audubon, PA (8 miles from Harleysville, PA)
- 90+ 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 Harleysville, PA
Moving to Harleysville, PA? Find some basic demographic data about Harleysville, PA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Harleysville, PA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Harleysville, 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
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Business Processes
- Medical Device Sales
- FDA Regulations
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Process Improvement
- Auditing
- Military Background
- Implementation
- Analytical Skills
- Investigation
- Written Communication
- Education Experience
- Verbal Communication
- Documentation
- Data Analysis
- Reporting
- Collaboration
- Filing
- Microsoft PowerPoint
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Sales
- 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 »