Regulatory Affairs Specialist Jobs in Malvern, 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.
- Universal Health Services
- King of Prussia, PA (8 miles from Malvern, PA)
- 2 days ago
- King of Prussia, PA (8 miles from Malvern, PA)
- 2 days ago
Responsibilities (This role has a hybrid schedule with 3 days in office and 2 days flex-remote) Join a dynamic organization driven by our passion for healthcare. UHS is seeking talented...
HybridEarned Value Compliance Analyst (Subject Matter Expert)
- Boeing
- Ridley Park, PA (16 miles from Malvern, PA)
- 5 days ago
- Ridley Park, PA (16 miles from Malvern, PA)
- 5 days ago
Job Description At Boeing, we innovate and collaborate to make the world a better place. We're committed to fostering an environment for every teammate that's welcoming, respectful and inclusive,...
Hybrid- Arch Capital Group Ltd.
- Philadelphia, PA (20 miles from Malvern, PA)
- 6 days ago
- Philadelphia, PA (20 miles from Malvern, PA)
- 6 days ago
With a company culture rooted in collaboration, expertise and innovation, we aim to promote progress and inspire our clients, employees, investors and communities to achieve their greatest...
Remote HybridSr. Specialist Regulatory Affairs, Medical Devices
- West Pharmaceutical Services
- Exton, PA (5 miles from Malvern, PA)
- 7 days ago
- Exton, PA (5 miles from Malvern, PA)
- 7 days ago
Systems R.A.C certification(s) License and Certifications Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred Travel Requirements 10%: Up to 26 business days per year Physical...
Hybrid- RevSpring Inc
- Oaks, PA (7 miles from Malvern, PA)
- 17 days ago
- Oaks, PA (7 miles from Malvern, PA)
- 17 days ago
IT Audit & Compliance Analyst Position Summary The IT Audit & Compliance Analyst is responsible for driving audit execution and regulatory compliance efforts across the organization, with primary...
In PersonPrincipal Specialist, Regulatory Affairs
- West Pharmaceutical Services
- Exton, PA (5 miles from Malvern, PA)
- 18 days ago
- Exton, PA (5 miles from Malvern, PA)
- 18 days ago
(k) device and EU technical documentation submissions....
Hybrid- Ascensus
- Dresher, PA (20 miles from Malvern, PA)
- 19 days ago
- Dresher, PA (20 miles from Malvern, PA)
- 19 days ago
Ascensus is the leading independent technology and service platform powering savings plans across America, providing products and expertise that help nearly 16 million people save for a better...
In PersonRemote Retirement Plan Compliance Analyst
- Ascensus
- Philadelphia, PA (20 miles from Malvern, PA)
- 19 days ago
- Philadelphia, PA (20 miles from Malvern, PA)
- 19 days ago
FuturePlan is the nation's largest third-party administrator (TPA) of retirement plans, partnering with advisors in all 50 states. FuturePlan delivers the best of both worlds: high-touch...
Remote- PJM Search
- Audubon, PA (11 miles from Malvern, PA)
- 21 days ago
- Audubon, PA (11 miles from Malvern, PA)
- 21 days ago
Flexible Work Arrangement: Hybrid The Sr. Compliance Analyst is responsible for securely managing the Account Authorization and associated compliance processes managed by the Identity and Access...
In PersonSr Compliance Analyst - Records Management (Hybrid)
- Aegon
- Philadelphia, PA (20 miles from Malvern, PA)
- 23 days ago
- Philadelphia, PA (20 miles from Malvern, PA)
- 23 days ago
These are supported by Transamerica Corporate, which includes Finance, People and Places, General Counsel, Risk, Internal Audit, Strategy and Development, and Corporate Affairs, which covers Communications...
HybridSenior Specialist, Regulatory Affairs
- 1000 Merck Sharp & Dohme LLC
- North Wales, PA (18 miles from Malvern, PA)
- 30+ days ago
- North Wales, PA (18 miles from Malvern, PA)
- 30+ days ago
The Senior Specialist is responsible for the review and approval of US promotional materials. As a member of the Review Team, work collaboratively with legal, medical, and commercial colleagues to...
HybridSenior Compliance Analyst - Conflicts Review - Hybrid
- Aegon
- Philadelphia, PA (20 miles from Malvern, PA)
- 45+ days ago
- Philadelphia, PA (20 miles from Malvern, PA)
- 45+ days ago
These are supported by Transamerica Corporate, which includes Finance, People and Places, General Counsel, Risk, Internal Audit, Strategy and Development, and Corporate Affairs, which covers Communications...
HybridRegulatory Affairs Specialist, Global
- Quaker Chemical Corporation
- Conshohocken, PA (12 miles from Malvern, PA)
- 60+ days ago
- Conshohocken, PA (12 miles from Malvern, PA)
- 60+ days ago
Assist the Product Stewardship team with a variety of administrative and data management activities to support global regulatory activities. This includes responsibility for providing support of...
In PersonIntermediate Compliance Analyst - Conflicts Review - Hybrid
- Aegon
- Philadelphia, PA (20 miles from Malvern, PA)
- 90+ days ago
- Philadelphia, PA (20 miles from Malvern, PA)
- 90+ days ago
These are supported by Transamerica Corporate, which includes Finance, People and Places, General Counsel, Risk, Internal Audit, Strategy and Development, and Corporate Affairs, which covers Communications...
HybridIT Security Compliance Analyst
- Liberty Personnel
- Philadelphia, PA (20 miles from Malvern, PA)
- 90+ days ago
- Philadelphia, PA (20 miles from Malvern, PA)
- 90+ days ago
Job Details: IT Security Compliance Analyst I'm seeking an IT Security Compliance Analyst for a Full-time position with a stable and growing company in the local area. Interested candidates should...
RemoteDemographic Data for Malvern, PA
Moving to Malvern, PA? Find some basic demographic data about Malvern, PA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Malvern, PA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Malvern, 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
- Filing
- Financial Services
- Reimbursement
- Annuities
- Quality Management Systems
- 21 CFR 820
- Internal Audits
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Continuous Improvement
- Product Development
- Microsoft SharePoint
- Technical Writing
- Analytical Skills
- Risk Management
- Engineering
- Strategy Development
- Auditing
- Military Background
- Written Communication
- Investigation
- Process Improvement
- Documentation
- Implementation
- Verbal Communication
- Reporting
- Policy Development
- Data Analysis
- Education Experience
- Collaboration
- Microsoft PowerPoint
- Bachelor's Degree
- Regulations
- Microsoft Word
- Microsoft Excel
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Time Management
- Leadership
- Communication Skills
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