Regulatory Affairs Specialist Jobs in Downingtown, 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.
Governance, Risk and Compliance Analyst
- Wilmington, DE (24 miles from Downingtown, PA)
- 2 days ago
- Wilmington, DE (24 miles from Downingtown, PA)
- 2 days ago
Job Description At WSFS Bank, we empower our Associates to grow their careers, guide our customers to secure their financial futures, and actively support our Communities so they can fully thrive....
- Wilmington, DE (24 miles from Downingtown, PA)
- 8 days ago
- Wilmington, DE (24 miles from Downingtown, PA)
- 8 days ago
Looing for compliance tester within auto, credit cards, commercial and deposit consumer lending divisions. They have a QC independent testing function where they look at previous data of month or...
Regulatory Affairs Specialist, Senior
- Wilmington, DE (24 miles from Downingtown, PA)
- 14 days ago
- Wilmington, DE (24 miles from Downingtown, PA)
- 14 days ago
The Senior Regulatory Affairs Specialist is responsible for the successful implementation of regulatory goals and objectives....
- Wilmington, DE (24 miles from Downingtown, PA)
- 20 days ago
- Wilmington, DE (24 miles from Downingtown, PA)
- 20 days ago
Company :** Highmark Health **Job Description :** **JOB SUMMARY** This job works collaboratively to support of all risk and compliance assessment activities of Highmark Health across a broad range...
Sr Product Stewardship & Regulatory Affairs Specialist Job
- Radnor, PA (16 miles from Downingtown, PA)
- 23 days ago
- Radnor, PA (16 miles from Downingtown, 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 (17 miles from Downingtown, PA)
- 25 days ago
- King of Prussia, PA (17 miles from Downingtown, 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 (17 miles from Downingtown, PA)
- 25 days ago
- King of Prussia, PA (17 miles from Downingtown, 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,...
Portfolio Compliance Analyst - Delaware
- Wilmington, DE (24 miles from Downingtown, PA)
- 30+ days ago
- Wilmington, DE (24 miles from Downingtown, PA)
- 30+ days ago
About this role Portfolio Compliance Group Implementation Team Have a passion for the investment industry and an interest in programming? Are you a compliance professional who is looking for a...
Senior Specialist, Regulatory Affairs - Medical Device
- Exton, PA (4 miles from Downingtown, PA)
- 60+ days ago
- Exton, PA (4 miles from Downingtown, 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 (4 miles from Downingtown, PA)
- 60+ days ago
- Exton, PA (4 miles from Downingtown, 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 (17 miles from Downingtown, PA)
- 60+ days ago
- King of Prussia, PA (17 miles from Downingtown, 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 (17 miles from Downingtown, PA)
- 60+ days ago
- King of Prussia, PA (17 miles from Downingtown, 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 (20 miles from Downingtown, PA)
- 90+ days ago
- Audubon, PA (20 miles from Downingtown, 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 Downingtown, PA
Moving to Downingtown, PA? Find some basic demographic data about Downingtown, PA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Downingtown, PA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Downingtown, 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
- 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
- Interpersonal Skills
- 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
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