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.
Senior Regulatory Affairs Specialist - Electrophysiology (on-site)
- Plymouth, MN
- 1 day ago
- Plymouth, MN
- 1 day ago
The Opportunity We are recruiting for a Senior Regulatory Affairs Specialist to join our team on-site in our St. Paul or Plymouth, MN locations....
Regulatory Affairs Specialist I - Heart Failure (on-site)
- Pleasanton, CA
- 2 days ago
- Pleasanton, CA
- 2 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...
Principal Regulatory Affairs Specialist - Vascular (on-site)
- Saint Paul, MN
- 8 days ago
- Saint Paul, MN
- 8 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)....
Regulatory Affairs Specialist, you will provide support to the Regulatory Affairs department to ensure efficient and compliant business processes and environment are followed....
About us We were built on the philosophy that marketing and compliance can absolutely work in harmony and that this combined strategy would help build solid financial services firms. After...
Assists the MedStar Family Choice (MFC) compliance and privacy programs. Conducts both internal and external audits to ensure compliance with regulatory requirements. We recruit, retain, and...
Calista Corporation Regular JOB SUMMARY The Senior Regulatory & Compliance Specialist ensures corporate and subsidiary compliance with federal, state, and local regulations, with a strong focus on...
The Senior Analyst will be expected to support the preparation of audit documents prior to external audits and to conduct regular internal audits of individual Standards....
Job Scope The Regulatory Affairs Specialist 3 develops and executes regulatory strategy and integrates regulatory requirements throughout the product lifecycle....
Regulatory Affairs Specialist Senior (Department of Ophthalmology)
- Philadelphia, PA
- 4 hours ago
- Philadelphia, PA
- 4 hours ago
Posted Job Title Regulatory Affairs Specialist Senior (Department of Ophthalmology) Job Profile Title Regulatory Affairs Specialist Senior Job Description Summary Ophthalmology seeks part-time Regulatory...
audits to ensure regulatory compliance in an assigned area such as Documentation, Coding Insurance, and Health Insurance Portability and Accountability Act (HIPAA)....
Join a great place to work with MissionSquare, a financial services corporation with approximately $79 billion in assets under management and administration and over 600 employees. Founded in...
Sabre is a technology company that powers the global travel industry. By leveraging next-generation technology, we create global technology solutions that take on the biggest opportunities and...
Regulatory Affairs Specialist Job Description We are seeking a Regulatory Affairs Contractor to contribute to the development and execution of effective regulatory strategies for investigational products...
Audit, and external third parties Assist with the maintenance and update of ITCC program documents Maintain an understanding of Company and IT objectives and risks Assist with other Information Security...
Remote WorkRegulatory 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
- Analytical Skills
- Filing
- Financial Services
- Mortgage Processing
- Reimbursement
- Juris Doctor
- Internal Audits
- Quality Systems
- 21 CFR 820
- ISO 9001
- ISO 13485
- ISO 14001
- Quality Management
- Process Controls
- Medical Device Sales
- Business Processes
- FDA Regulations
- Microsoft Visio
- Standard Operating Procedures
- Engineering
- Product Development
- Affirmative Action
- Risk Management
- Quality Assurance
- Process Improvement
- Implementation
- Military Background
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Reporting
- Education Experience
- Bachelor's Degree
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Microsoft Office
- Microsoft Excel
- Problem Solving
- Time Management
- Teamwork
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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