Regulatory Affairs Specialist Jobs in Holmdel, NJ
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.
- New Brunswick, NJ (16 miles from Holmdel, NJ)
- 3 days ago
- New Brunswick, NJ (16 miles from Holmdel, NJ)
- 3 days ago
Company: Kelly Services Location: New Brunswick, NJ Career Level: Associate Industries: Recruitment Agency, Staffing, Job Board Description At Kelly Professional & Industrial, we're all about...
- New Brunswick, NJ (16 miles from Holmdel, NJ)
- 4 days ago
- New Brunswick, NJ (16 miles from Holmdel, NJ)
- 4 days ago
At Kelly Professional & Industrial, were all about helping you discover whats next in your career. Are you a recent graduate with a keen eye for detail and a passion for data analytics? Do you...
- Arverne, NY (24 miles from Holmdel, NJ)
- 5 days ago
- Arverne, NY (24 miles from Holmdel, NJ)
- 5 days ago
Support internal audits and coordinate external audits, including documentation gathering and response to findings....
- New York City, NY (24 miles from Holmdel, NJ)
- 9 days ago
- New York City, NY (24 miles from Holmdel, NJ)
- 9 days ago
About the Agency: The New York City Department of Housing Preservation Development (HPD) promotes quality and affordability in the city's housing, and diversity and strength in the city's...
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Principal Regulatory Affairs Specialist (SaMD)
- New York City, NY (24 miles from Holmdel, NJ)
- 12 days ago
- New York City, NY (24 miles from Holmdel, NJ)
- 12 days ago
Expertise: Demonstrated knowledge of FDA regulations, ISO/EN standards and global regulatory requirements for medical devices....
Guided by our company Purpose of "Inspiring well-being for our colleagues, consumers, and communities," we are committed to building a best-in-class Law Department. We drive a high-performance...
Sr. Security Governance, Risk & Compliance Analyst - Paze
- New York City, NY (24 miles from Holmdel, NJ)
- 26 days ago
- New York City, NY (24 miles from Holmdel, NJ)
- 26 days ago
Act as Point of Contact and Project Manager for Information Technology and Security focused external and internal audits and assessments (SOC-2, GLBA, FISMA, PCI DSS, FFIEC, & others)....
Senior Auditing & Compliance Analyst
- New York City, NY (24 miles from Holmdel, NJ)
- 27 days ago
- New York City, NY (24 miles from Holmdel, NJ)
- 27 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...
- Newark, NJ (24 miles from Holmdel, NJ)
- 30+ days ago
- Newark, NJ (24 miles from Holmdel, NJ)
- 30+ days ago
Compliance Analyst Business Operations and Management $ 63 / Hour location_on Newark, New Jerseypass_calibration Remote work_outline Contract/Temporary favorite_border JOB ON CANDIDATE PORTAL COPY...
Market Data Compliance Analyst
- New York City, NY (24 miles from Holmdel, NJ)
- 30+ days ago
- New York City, NY (24 miles from Holmdel, NJ)
- 30+ days ago
Overview Job Purpose The Market Data Compliance Analyst is essential for the governance of NYSE's commercial market data business. The role will be responsible for conducting data usage reviews of...
- New York City, NY (24 miles from Holmdel, NJ)
- 45+ days ago
- New York City, NY (24 miles from Holmdel, NJ)
- 45+ days ago
PingPong was founded in New York in 2015, with the goal of solving the immense challenge of scaling enterprise businesses globally. Fast forward to today, and PingPong has become one of the...
- New York City, NY (24 miles from Holmdel, NJ)
- 45+ days ago
- New York City, NY (24 miles from Holmdel, NJ)
- 45+ days ago
The New York City Department of Sanitation (DSNY) keeps New York City healthy, safe, and clean by collecting, recycling, and disposing of waste, cleaning City streets and vacant lots, and clearing...
- New York City, NY (24 miles from Holmdel, NJ)
- 45+ days ago
- New York City, NY (24 miles from Holmdel, NJ)
- 45+ days ago
Agency Description: The New York City Department of Housing Preservation & Development ("HPD") is the nation's largest municipal housing preservation and development agency. Its mission is to...
Contract and Compliance Analyst
- New York City, NY (24 miles from Holmdel, NJ)
- 90+ days ago
- New York City, NY (24 miles from Holmdel, NJ)
- 90+ days ago
The New York City Department of Sanitation (DSNY) keeps New York City healthy, safe, and clean by collecting, recycling, and disposing of waste, cleaning City streets and vacant lots, and clearing...
Compliance Analyst - Alternative Risk (Remote or Eatontown, NJ)
- Eatontown, NJ (7 miles from Holmdel, NJ)
- 90+ days ago
- Eatontown, NJ (7 miles from Holmdel, NJ)
- 90+ days ago
Crum & Forster Company Overview Crum & Forster (C&F), with a proud history dating to 1822, provides specialty and standard commercial lines insurance products through our admitted and surplus...
Remote WorkDemographic Data for Holmdel, NJ
Moving to Holmdel, NJ? Find some basic demographic data about Holmdel, NJ below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Holmdel, NJ
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Holmdel, NJ 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
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Resolution
- Product Development
- Risk Management
- Engineering
- Strategy Development
- Process Improvement
- Military Background
- Implementation
- Auditing
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Data Analysis
- Collaboration
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Reporting
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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