Regulatory Affairs Specialist Jobs in New Hope, 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.
- Trenton, NJ (16 miles from New Hope, PA)
- 3 days ago
- Trenton, NJ (16 miles from New Hope, PA)
- 3 days ago
. + Own audit readiness and guide teams through federal and state exams, internal audits, and testing processes with confidence and clarity. + Turn insights into action by analyzing results, delivering...
Remote WorkLead Regulatory Affairs Specialist
- Audubon, PA (24 miles from New Hope, PA)
- 6 days ago
- Audubon, PA (24 miles from New Hope, PA)
- 6 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. (Lead) Compliance Analyst I (II)
- Audubon, PA (24 miles from New Hope, PA)
- 16 days ago
- Audubon, PA (24 miles from New Hope, 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...
- Trenton, NJ (16 miles from New Hope, PA)
- 18 days ago
- Trenton, NJ (16 miles from New Hope, PA)
- 18 days ago
Your Future Evolves Here Evolent partners with health plans and providers to achieve better outcomes for people with most complex and costly health conditions. Working across specialties and...
Sr Regulatory Affairs Specialist
- Audubon, PA (24 miles from New Hope, PA)
- 22 days ago
- Audubon, PA (24 miles from New Hope, PA)
- 22 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...
- Blue Bell, PA (19 miles from New Hope, PA)
- 28 days ago
- Blue Bell, PA (19 miles from New Hope, PA)
- 28 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 (15 miles from New Hope, PA)
- 30+ days ago
- Huntingdon Valley, PA (15 miles from New Hope, PA)
- 30+ 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...
Regulatory Compliance Specialist (9891)
- Morrisville, PA (14 miles from New Hope, PA)
- 30+ days ago
- Morrisville, PA (14 miles from New Hope, PA)
- 30+ days ago
Grow a Better Tomorrow with Nufarm. We know that growing is about more than just crops and cultivation. It's about sunshine and rain, early mornings and hard work. It can be frustratingly...
- Trenton, NJ (16 miles from New Hope, PA)
- 45+ days ago
- Trenton, NJ (16 miles from New Hope, PA)
- 45+ days ago
Job Order Number: DE9405993 Job Title: Trade Compliance Analyst Company: Otsuka America Pharmaceutical Inc. Location: Trenton, NJ Salary: Education: Less Than High School Experience: None Hours:...
Demographic Data for New Hope, PA
Moving to New Hope, PA? Find some basic demographic data about New Hope, PA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in New Hope, PA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in New Hope, 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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