Regulatory Affairs Specialist Jobs in Birchrunville, 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 & Compliance Analyst, Specialist
- Malvern, PA (8 miles from Birchrunville, PA)
- 5 days ago
- Malvern, PA (8 miles from Birchrunville, PA)
- 5 days ago
Recommends, develops, implements, and monitors enterprise-wide information security policies, procedures, and operational guidelines. Researches and develops solutions for information security...
Sr. (Lead) Compliance Analyst I (II)
- Audubon, PA (13 miles from Birchrunville, PA)
- 6 days ago
- Audubon, PA (13 miles from Birchrunville, PA)
- 6 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...
Tax Reporting Compliance Analyst - Hybrid
- Newtown Square, PA (14 miles from Birchrunville, PA)
- 9 days ago
- Newtown Square, PA (14 miles from Birchrunville, PA)
- 9 days ago
This role is hybrid and requires 3 days/week in the office located in Newtown Square, PA. Your career starts now. Were looking for the next generation of health care leaders. At AmeriHealth...
Senior Regulatory Affairs Specialist
- Exton, PA (6 miles from Birchrunville, PA)
- 10 days ago
- Exton, PA (6 miles from Birchrunville, PA)
- 10 days ago
West Pharmaceutical Services, Inc. seeks a Senior Regulatory Affairs Specialist at its Exton, PA location....
Remote WorkSr Regulatory Affairs Specialist
- Audubon, PA (13 miles from Birchrunville, PA)
- 12 days ago
- Audubon, PA (13 miles from Birchrunville, PA)
- 12 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...
- King of Prussia, PA (12 miles from Birchrunville, PA)
- 17 days ago
- King of Prussia, PA (12 miles from Birchrunville, PA)
- 17 days ago
Reference #: ... Why you'll LOVE Sagent: You could work anywhere. We know you are talented and looking for something inspiring and impactful. A place where you will make a difference and have a...
Compliance Analyst I - Supervisory Control Policies and Procedures
- Greenville, DE (23 miles from Birchrunville, PA)
- 22 days ago
- Greenville, DE (23 miles from Birchrunville, PA)
- 22 days ago
Compliance Analyst I - Supervisory Control Policies and Procedures Location US-MO-Saint Louis ID 2025-7372 Category Compliance Position Type Regular | Full Time Work Type Onsite What You'll Be...
Regulatory Affairs Specialist, Senior
- Talleyville, DE (23 miles from Birchrunville, PA)
- 23 days ago
- Talleyville, DE (23 miles from Birchrunville, PA)
- 23 days ago
The Senior Regulatory Affairs Specialist is responsible for the successful implementation of regulatory goals and objectives....
- Berwyn, PA (11 miles from Birchrunville, PA)
- 28 days ago
- Berwyn, PA (11 miles from Birchrunville, PA)
- 28 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...
Compliance Analyst - Operations Analyst Program: August 2025 Start
- Bala Cynwyd, PA (22 miles from Birchrunville, PA)
- 30+ days ago
- Bala Cynwyd, PA (22 miles from Birchrunville, PA)
- 30+ days ago
Overview The Operations Analyst Program is a rotational development program that offers a broad and in-depth exposure to business operations at Susquehanna and will prepare you for a Compliance...
Legal/Regulatory Compliance Associate
- West Chester, PA (10 miles from Birchrunville, PA)
- 90+ days ago
- West Chester, PA (10 miles from Birchrunville, 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...
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Birchrunville, PA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Birchrunville, 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
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Medical Device Sales
- FDA Regulations
- Business Processes
- Document Management
- Microsoft Visio
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Reporting
- Data Analysis
- Education Experience
- Interpersonal Skills
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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