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.
Compliance Analyst, Specialist
- Malvern, PA (21 miles from Birdsboro, PA)
- moments ago
- Malvern, PA (21 miles from Birdsboro, PA)
- moments 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...
Corporate Governance & Compliance Analyst
- Reading, PA (9 miles from Birdsboro, PA)
- 45+ days ago
- Reading, PA (9 miles from Birdsboro, PA)
- 45+ 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)
- 45+ days ago
- Reading, PA (9 miles from Birdsboro, PA)
- 45+ 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 WorkSenior Specialist, Regulatory Affairs - Medical Device
- Exton, PA (17 miles from Birdsboro, PA)
- 60+ days ago
- Exton, PA (17 miles from Birdsboro, 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 (17 miles from Birdsboro, PA)
- 60+ days ago
- Exton, PA (17 miles from Birdsboro, 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 Regulatory Affairs Specialist
- Audubon, PA (24 miles from Birdsboro, PA)
- 90+ days ago
- Audubon, PA (24 miles from Birdsboro, 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 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
- 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
- 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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