Regulatory Affairs Specialist Jobs in Sparta, 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.
Regulatory Affairs Specialist (Defined Term)
- Getinge Group
- Wayne, NJ (20 miles from Sparta, NJ)
- 6 days ago
- Wayne, NJ (20 miles from Sparta, NJ)
- 6 days ago
Prepares documentation and coordinates activities related to EuMDR, PMA amendments, PMA supplements, PMA annual reports, Q-subs, 510(k)s and IEDs....
In PersonStaff Regulatory Affairs Specialist
- Stryker
- Mahwah, NJ (22 miles from Sparta, NJ)
- 14 days ago
- Mahwah, NJ (22 miles from Sparta, NJ)
- 14 days ago
Work Flexibility: Hybrid Stryker is hiring a Staff Regulatory Affairs Specialist in Mahwah, NJ to ensure continued market access and regulatory compliance for its Joint Replacement implant and instrument...
In PersonRegulatory Affairs Specialist, Digitalization
- Becton Dickinson & Company
- Franklin Lakes, NJ (21 miles from Sparta, NJ)
- 15 days ago
- Franklin Lakes, NJ (21 miles from Sparta, NJ)
- 15 days ago
The Regulatory Affairs Specialist, Digitalization will work with SMEs and stakeholders from Central, BU and Regional teams to ensure user needs are identified and met....
In PersonSenior International Regulatory Affairs Specialist
- Becton Dickinson & Company
- Franklin Lakes, NJ (21 miles from Sparta, NJ)
- 16 days ago
- Franklin Lakes, NJ (21 miles from Sparta, NJ)
- 16 days ago
amp;#xa; We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and its no...
In PersonRegulatory Affairs Associate Director, Globalization
- Becton, Dickinson and Company
- Franklin Lakes, NJ (21 miles from Sparta, NJ)
- 19 days ago
- Franklin Lakes, NJ (21 miles from Sparta, NJ)
- 19 days ago
amp;#xa; We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and its no...
In PersonRegulatory Compliance Specialist
- System One
- Montville, NJ (16 miles from Sparta, NJ)
- 22 days ago
- Montville, NJ (16 miles from Sparta, NJ)
- 22 days ago
We help clients get work done more efficiently and economically, without compromising quality....
In PersonPrincipal Global Trade Compliance Analyst (Hybrid)
- BAE Systems
- Wayne, NJ (20 miles from Sparta, NJ)
- 23 days ago
- Wayne, NJ (20 miles from Sparta, NJ)
- 23 days ago
Job Order Number: DF0739289 Job Title: Principal Global Trade Compliance Analyst (Hybrid) Company: BAE Systems Location: Wayne, NJ Salary: Education: Information Not Provided Experience:...
Hybrid- SGS
- Fairfield, NJ (20 miles from Sparta, NJ)
- 27 days ago
- Fairfield, NJ (20 miles from Sparta, NJ)
- 27 days ago
Company Description SGS is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality...
In PersonSenior Supply Chain Compliance Analyst (SOX)
- Core Weave
- Livingston, NJ (23 miles from Sparta, NJ)
- 30+ days ago
- Livingston, NJ (23 miles from Sparta, NJ)
- 30+ days ago
Partner with Finance SOX, Internal Audit, IT, and supply chain process owners to design and operate effective controls in NetSuite and Coupa (approvals, reconciliations, 3-way match, SoD, access)....
Hybrid- Mahwah, NJ (22 miles from Sparta, NJ)
- 30+ days ago
- Mahwah, NJ (22 miles from Sparta, NJ)
- 30+ days ago
Job Title: Regulatory Affairs Specialist Job Description Join our team as a Regulatory Affairs Specialist, where you'll coordinate, prepare, and review regulatory documents and certifications for domestic...
HybridCompliance Analyst - Health, Life and Benefits
- ADP
- Florham Park, NJ (22 miles from Sparta, NJ)
- 90+ days ago
- Florham Park, NJ (22 miles from Sparta, NJ)
- 90+ days ago
ADP is hiring a Compliance Analyst. Monitor licenses of all associates who are required to maintain an insurance license, including conducting monthly license audit; and enforcing ADPIA license...
In PersonDemographic Data for Sparta, NJ
Moving to Sparta, NJ? Find some basic demographic data about Sparta, NJ below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Sparta, NJ
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Sparta, 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
- 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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