Regulatory Affairs Specialist Jobs in Elkton, MD
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 and Compliance Analyst
- Wilmington, DE (19 miles from Elkton, MD)
- 2 days ago
- Wilmington, DE (19 miles from Elkton, MD)
- 2 days ago
Job Description At WSFS Bank, we empower our Associates to grow their careers, guide our customers to secure their financial futures, and actively support our Communities so they can fully thrive....
- Wilmington, DE (19 miles from Elkton, MD)
- 8 days ago
- Wilmington, DE (19 miles from Elkton, MD)
- 8 days ago
Looing for compliance tester within auto, credit cards, commercial and deposit consumer lending divisions. They have a QC independent testing function where they look at previous data of month or...
Senior Regulatory Affairs Specialist
- Newark, DE (8 miles from Elkton, MD)
- 11 days ago
- Newark, DE (8 miles from Elkton, MD)
- 11 days ago
Join us as a Regulatory Affairs Specialist-Sustaining, and play a pivotal role in supporting and improving mature products and processes....
Regulatory Affairs Specialist 3
- Newark, DE (8 miles from Elkton, MD)
- 14 days ago
- Newark, DE (8 miles from Elkton, MD)
- 14 days ago
expertise preparing and maintaining regulatory submissions and technical files for mature and evolving products (US, EU, and Canada) Strong understanding of relevant regulations and standards (FDA, ISO...
Regulatory Affairs Specialist, Senior
- Wilmington, DE (19 miles from Elkton, MD)
- 14 days ago
- Wilmington, DE (19 miles from Elkton, MD)
- 14 days ago
The Senior Regulatory Affairs Specialist is responsible for the successful implementation of regulatory goals and objectives....
- Wilmington, DE (19 miles from Elkton, MD)
- 20 days ago
- Wilmington, DE (19 miles from Elkton, MD)
- 20 days ago
Company :** Highmark Health **Job Description :** **JOB SUMMARY** This job works collaboratively to support of all risk and compliance assessment activities of Highmark Health across a broad range...
Portfolio Compliance Analyst - Delaware
- Wilmington, DE (19 miles from Elkton, MD)
- 30+ days ago
- Wilmington, DE (19 miles from Elkton, MD)
- 30+ days ago
About this role Portfolio Compliance Group Implementation Team Have a passion for the investment industry and an interest in programming? Are you a compliance professional who is looking for a...
Regulatory Affairs Specialist 4
- Newark, DE (8 miles from Elkton, MD)
- 90+ days ago
- Newark, DE (8 miles from Elkton, MD)
- 90+ days ago
The Regulatory Affairs Specialist 4 performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local...
Demographic Data for Elkton, MD
Moving to Elkton, MD? Find some basic demographic data about Elkton, MD below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Elkton, MD
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Elkton, MD offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Business Processes
- Medical Device Sales
- FDA Regulations
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Process Improvement
- Auditing
- Military Background
- Implementation
- Analytical Skills
- Investigation
- Written Communication
- Education Experience
- Verbal Communication
- Documentation
- Data Analysis
- Reporting
- Collaboration
- Interpersonal Skills
- Filing
- Microsoft PowerPoint
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Sales
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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