Regulatory Affairs Specialist Jobs in Montgomeryville, 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.
- Philadelphia, PA (19 miles from Montgomeryville, PA)
- 1 day ago
- Philadelphia, PA (19 miles from Montgomeryville, PA)
- 1 day ago
Trade Compliance Analyst Who We Are: GEODIS specializes in unlocking business value in a complex world, ensuring seamless movement of goods worldwide. As a global third-party logistics provider...
Principal Regulatory Affairs Specialist, Pharmaceutical Products (Hybrid)
- Philadelphia, PA (19 miles from Montgomeryville, PA)
- 4 days ago
- Philadelphia, PA (19 miles from Montgomeryville, PA)
- 4 days ago
We are currently seeking a **Principal Regulatory Affairs Specialist,** ( **Pharmaceutical Products** ) to join our **Medical** Division. This is a Hybrid role based in Cary, Illinois....
Senior Auditing & Compliance Analyst
- Philadelphia, PA (19 miles from Montgomeryville, PA)
- 4 days ago
- Philadelphia, PA (19 miles from Montgomeryville, PA)
- 4 days ago
The Compliance Analyst, Health & Regulatory Compliance Group will support all members of the Health Regulatory & Compliance Group with managing multiple activities and projects required for...
Governance, Risk & Compliance Analyst, Specialist
- Malvern, PA (20 miles from Montgomeryville, PA)
- 5 days ago
- Malvern, PA (20 miles from Montgomeryville, 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 (9 miles from Montgomeryville, PA)
- 6 days ago
- Audubon, PA (9 miles from Montgomeryville, 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 (19 miles from Montgomeryville, PA)
- 9 days ago
- Newtown Square, PA (19 miles from Montgomeryville, 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...
Sr. (Lead) Compliance Analyst I (II)
- Audubon, NJ (24 miles from Montgomeryville, PA)
- 9 days ago
- Audubon, NJ (24 miles from Montgomeryville, PA)
- 9 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...
Sr Regulatory Affairs Specialist
- Audubon, PA (9 miles from Montgomeryville, PA)
- 11 days ago
- Audubon, PA (9 miles from Montgomeryville, PA)
- 11 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...
Senior Privacy Compliance Analyst
- Mount Laurel, NJ (24 miles from Montgomeryville, PA)
- 16 days ago
- Mount Laurel, NJ (24 miles from Montgomeryville, PA)
- 16 days ago
Provides responses to regulatory agencies and Internal Audit....
- King of Prussia, PA (12 miles from Montgomeryville, PA)
- 17 days ago
- King of Prussia, PA (12 miles from Montgomeryville, 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...
- Philadelphia, PA (19 miles from Montgomeryville, PA)
- 18 days ago
- Philadelphia, PA (19 miles from Montgomeryville, PA)
- 18 days ago
Who are we? Equinix is the worlds digital infrastructure company, operating over 26 0 data centersacross the globe. Digital leaders harness Equinix's trusted platform to bring together and...
- Mount Laurel, NJ (24 miles from Montgomeryville, PA)
- 18 days ago
- Mount Laurel, NJ (24 miles from Montgomeryville, PA)
- 18 days ago
This role will be part of the Producer Compliance team responsible for end to end handling of the onboarding of insurance producer business partners (insurance brokers and agents) to ensure...
Compliance Analyst / NIST / Greater Philadelphia Area Only
- Huntingdon Valley, PA (11 miles from Montgomeryville, PA)
- 22 days ago
- Huntingdon Valley, PA (11 miles from Montgomeryville, PA)
- 22 days ago
This local data management company is looking for a Compliance Analyst to join their team. This person will be involved with a wide range of risk and audit engagements, mostly in the government...
Compliance Analyst (Banking/Finance) - Hybrid 2 days/week onsite
- Mount Laurel, NJ (24 miles from Montgomeryville, PA)
- 23 days ago
- Mount Laurel, NJ (24 miles from Montgomeryville, PA)
- 23 days ago
Compliance Analyst (Banking/Finance) - Hybrid 2 days/week onsite Role: Mortgage/Loans Compliance Analyst Work Location: Mount Laurel, NJ; Wilmington, DE; and Charlotte, NC for at least two days...
Compliance Analyst - Operations Analyst Program: August 2025 Start
- Philadelphia, PA (19 miles from Montgomeryville, PA)
- 30+ days ago
- Philadelphia, PA (19 miles from Montgomeryville, 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...
Demographic Data for Montgomeryville, PA
Moving to Montgomeryville, PA? Find some basic demographic data about Montgomeryville, PA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Montgomeryville, PA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Montgomeryville, 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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