Regulatory Affairs Specialist Jobs
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 Compliance Analyst: Oxford Life Insurance
- U-Haul - Oxford Life Insurance
- Phoenix, AZ
- 3 days ago
- U-Haul - Oxford Life Insurance
- Phoenix, AZ
- 3 days ago
Regulatory Compliance Analyst ( Med Supp ) / Med Supp Compliance Coordinator The Regulatory Compliance Analyst supports the Compliance, Actuarial, and Finance teams in the administration of Med...
ManTech is seeks a motivated, career-oriented SIGINT Compliance Analyst to support a critical mission in Ft. Meade, MD. The successful candidate will enhance the customers ability to manage...
Regulatory Affairs Specialist II Electrophysiology (on-site)
- Plymouth, MN
- 30+ days ago
- Plymouth, MN
- 30+ days ago
The Opportunity Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN....
Regulatory Affairs Specialist II - Ventures (on-site)
- Saint Paul, MN
- 45+ days ago
- Saint Paul, MN
- 45+ days ago
Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements...
Senior Regulatory Affairs Specialist Vascular (on-site)
- Santa Clara, CA
- 60+ days ago
- Santa Clara, CA
- 60+ days ago
This Senior Regulatory Affairs Specialist position is an onsite opportunity working out of our Santa Clara, CA location in the Abbott Vascular Division....
Principal Regulatory Affairs Specialist US New Product Introduction Diabetes Care (on-site)
- Alameda, CA
- 60+ days ago
- Alameda, CA
- 60+ days ago
Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC)....
Ready to be pushed beyond what you think you're capable of? At Coinbase, our mission is to increase economic freedom in the world. It's a massive, ambitious opportunity that demands the best of...
Ready to be pushed beyond what you think you're capable of? At Coinbase, our mission is to increase economic freedom in the world. It's a massive, ambitious opportunity that demands the best of...
Ready to be pushed beyond what you think you're capable of? At Coinbase, our mission is to increase economic freedom in the world. It's a massive, ambitious opportunity that demands the best of...
, ISO 13485, MDR/MDD, MDSAP compliant Quality System. 4....
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 of...
HealthRIGHT 360 gives hope, builds health, and changes lives for people in need by providing comprehensive, integrated, compassionate care that includes primary medical care, mental health...
Posting Date 07/11/20252000 16th Street, Denver, Colorado, 80202, United States of America The Communications Compliance Analyst will assist the corporate compliance education team in the...
Description You Can Change the Life of One to Care for the Lives of Many! At Galen College of Nursing, we educate and empower nurses to change lives. Since 1989, weve dedicated our work to...
Compliance Analyst - Operations
- Huntington Station, NY
- 5 hours ago
- Huntington Station, NY
- 5 hours ago
Interstate Waste Services is the most progressive and innovative provider of solid waste and recycling services in the country! We primarily service Northern New Jersey, Southern New York State,...
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs Nationwide
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Finance
- Vendor Management
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Standard Operating Procedures
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Education Experience
- Data Analysis
- Collaboration
- Documentation
- Reporting
- Filing
- Regulations
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Sales
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Leadership
- Communication Skills
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