Regulatory Affairs Specialist Jobs in Armonk, NY
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.
- Medtronic Inc.
- Bogota, NJ (24 miles from Armonk, NY)
- 5 hours ago
- Bogota, NJ (24 miles from Armonk, NY)
- 5 hours ago
Direct or perform coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections Lead or compile all materials required in submissions...
HybridAssoc Regulatory Affairs Specialist
- Medtronic Inc.
- Bogota, NJ (24 miles from Armonk, NY)
- 13 days ago
- Bogota, NJ (24 miles from Armonk, NY)
- 13 days ago
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to...
In PersonStaff Regulatory Affairs Specialist
- Stryker
- Mahwah, NJ (24 miles from Armonk, NY)
- 14 days ago
- Mahwah, NJ (24 miles from Armonk, NY)
- 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 Person- Fairfield University
- Fairfield, CT (22 miles from Armonk, NY)
- 23 days ago
- Fairfield, CT (22 miles from Armonk, NY)
- 23 days ago
Job Description: Division: Academics Department: Office of Institutional Research Primary Work Location: Fairfield University, Bellarmine Hall Reports to: Amy Boczer, Senior Director of...
In Person- Spire Orthopedic Partners
- Stamford, CT (10 miles from Armonk, NY)
- 26 days ago
- Stamford, CT (10 miles from Armonk, NY)
- 26 days ago
Job DetailsLevel: ExperiencedJob Location: MSO Corporate 1000 - Stamford, CT 06905Position Type: Full TimeEducation Level: BachelorsSalary Range: $85,000.00 - $127,600.00 SalaryTravel Percentage:...
RemoteRegulatory & Compliance Analyst
- KESHAV RX INX. DBA ADEE PHARMACY
- Bronx, NY (23 miles from Armonk, NY)
- 30+ days ago
- Bronx, NY (23 miles from Armonk, NY)
- 30+ days ago
Regulatory & Compliance Analyst is needed to perform the following duties : Monitor daily pharmacy operations to ensure compliance with applicable federal and state laws, Board of Pharmacy rules,...
In Person- Mahwah, NJ (24 miles from Armonk, NY)
- 30+ days ago
- Mahwah, NJ (24 miles from Armonk, NY)
- 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...
HybridRegulatory & Compliance Analyst
- NY DRUGS, INC. dba CASTLE HILL COMMUNITY PHARMACY
- Bronx, NY (23 miles from Armonk, NY)
- 45+ days ago
- Bronx, NY (23 miles from Armonk, NY)
- 45+ days ago
Regulatory & Compliance Analyst is needed to perform the following duties: Responsible for REGULATORY COMPLIANCE leading to pharmacy management: Leading and coordinating regulatory compliance...
In PersonDemographic Data for Armonk, NY
Moving to Armonk, NY? Find some basic demographic data about Armonk, NY below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Armonk, NY
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Armonk, NY 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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