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.
Lead Regulatory Affairs Specialist
- Audubon, PA (24 miles from Birdsboro, PA)
- 5 days ago
- Audubon, PA (24 miles from Birdsboro, PA)
- 5 days ago
Coordinates products in alignment with company policies as well as internal audits and inspections. Oversees all materials required in submissions, license renewal and annual registrations....
Sr. Specialist, Regulatory Affairs, Product Stewardship
- Exton, PA (17 miles from Birdsboro, PA)
- 8 days ago
- Exton, PA (17 miles from Birdsboro, PA)
- 8 days ago
This role is hybrid (3 days onsite) in Exton/Eagleview, PA. Candidates applying must be residing within a commutable 50 mile radius to the location. Who We Are: At West, were a dedicated team that...
Sr. (Lead) Compliance Analyst I (II)
- Audubon, PA (24 miles from Birdsboro, PA)
- 16 days ago
- Audubon, PA (24 miles from Birdsboro, PA)
- 16 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 to all...
Senior Regulatory Affairs Specialist
- Exton, PA (17 miles from Birdsboro, PA)
- 20 days ago
- Exton, PA (17 miles from Birdsboro, PA)
- 20 days ago
West Pharmaceutical Services, Inc. seeks a Senior Regulatory Affairs Specialist at its Exton, PA location....
Remote WorkSr Regulatory Affairs Specialist
- Audubon, PA (24 miles from Birdsboro, PA)
- 21 days ago
- Audubon, PA (24 miles from Birdsboro, PA)
- 21 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...
- Berwyn, PA (24 miles from Birdsboro, PA)
- 30+ days ago
- Berwyn, PA (24 miles from Birdsboro, PA)
- 30+ days ago
Reporting to the Senior Manager of IT Audit and Compliance, the IT Compliance Analyst will ensure that AMETEK maintains a steady state of IT compliance with all SOX audits and cybersecurity...
Legal/Regulatory Compliance Associate
- West Chester, PA (21 miles from Birdsboro, PA)
- 90+ days ago
- West Chester, PA (21 miles from Birdsboro, PA)
- 90+ days ago
As a Compliance Associate, you will be a contributing member of the Venerable Investment Advisers, to provide support and monitor various key processes and regulatory functions of the LLC...
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
- Medicaid
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Management Reporting
- Fraud Investigation
- Reimbursement
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Root Cause Analysis
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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