Regulatory Affairs Specialist Jobs in Birdsboro, 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.
Corporate Governance & Compliance Analyst
- Reading, PA (9 miles from Birdsboro, PA)
- 3 days ago
- Reading, PA (9 miles from Birdsboro, PA)
- 3 days ago
Corporate Governance & Compliance Analyst Enersys - 3.1 Reading, PA Job Details Estimated: $67.5K - $85.5K a year 15 hours ago Qualifications Microsoft Excel Mid-level Microsoft Office Project...
Remote WorkCorporate Legal Governance & Compliance Analyst
- Reading, PA (9 miles from Birdsboro, PA)
- 3 days ago
- Reading, PA (9 miles from Birdsboro, PA)
- 3 days ago
Corporate Legal Governance & Compliance Analyst Enersys - 3.1 Reading, PA Job Details Estimated: $67.5K - $85.5K a year 1 day ago Qualifications Microsoft Excel Mid-level Microsoft Office Project...
Remote Work- West Chester, PA (21 miles from Birdsboro, PA)
- 9 days ago
- West Chester, PA (21 miles from Birdsboro, 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 (21 miles from Birdsboro, PA)
- 12 days ago
- Malvern, PA (21 miles from Birdsboro, 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 (17 miles from Birdsboro, PA)
- 15 days ago
- Exton, PA (17 miles from Birdsboro, 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...
- Audubon, PA (24 miles from Birdsboro, PA)
- 28 days ago
- Audubon, PA (24 miles from Birdsboro, 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...
Senior Specialist, Regulatory Affairs
- Exton, PA (17 miles from Birdsboro, PA)
- 30+ days ago
- Exton, PA (17 miles from Birdsboro, 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 Regulatory Affairs Specialist
- Audubon, PA (24 miles from Birdsboro, PA)
- 60+ days ago
- Audubon, PA (24 miles from Birdsboro, 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 Birdsboro, PA
Moving to Birdsboro, PA? Find some basic demographic data about Birdsboro, PA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Birdsboro, PA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Birdsboro, 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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