Regulatory Affairs Specialist Jobs in Shrewsbury, MA
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.
- Waltham, MA (24 miles from Shrewsbury, MA)
- 10 hours ago
- Waltham, MA (24 miles from Shrewsbury, MA)
- 10 hours ago
The IT Compliance Analyst will be a critical part of the IT Team, reporting to the Director of IT Compliance. The IT Compliance Analyst will be responsible for assisting in the IT audit process...
Sr Regulatory Affairs Specialist (Medical Device)
- Framingham, MA (14 miles from Shrewsbury, MA)
- 27 days ago
- Framingham, MA (14 miles from Shrewsbury, MA)
- 27 days ago
Our client is currently seeking a Senior Regulatory Affairs Specialist. This is a permanent, direct hire, fully on-site position. Medical Device experience required....
Sr. Regulatory Compliance Specialist
- Marlborough, MA (9 miles from Shrewsbury, MA)
- 30+ days ago
- Marlborough, MA (9 miles from Shrewsbury, MA)
- 30+ days ago
Knowledge Deep understanding of global medical device regulatory frameworks and Quality Systems Management requirements....
- Needham, MA (23 miles from Shrewsbury, MA)
- 45+ days ago
- Needham, MA (23 miles from Shrewsbury, MA)
- 45+ days ago
The Analyst is primarily responsible for assisting with data validation management and quality assurance, consistent with the requirements of the Home Mortgage Disclosure Act (HMDA) and Community...
Senior Regulatory Affairs Specialist
- Marlborough, MA (9 miles from Shrewsbury, MA)
- 45+ days ago
- Marlborough, MA (9 miles from Shrewsbury, MA)
- 45+ days ago
Support quality system audits by notified bodies, government agencies and customers....
Demographic Data for Shrewsbury, MA
Moving to Shrewsbury, MA? Find some basic demographic data about Shrewsbury, MA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Shrewsbury, MA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Shrewsbury, MA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Consulting
- Environmental Compliance
- Geotechnical Engineering
- Civil Engineering
- Internal Audits
- 21 CFR 820
- ISO 13485
- Medical Device Sales
- Business Processes
- Microsoft Visio
- FDA Regulations
- Standard Operating Procedures
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Analytical Skills
- Implementation
- High School Diploma
- Investigation
- Written Communication
- Verbal Communication
- Data Analysis
- Collaboration
- Documentation
- Reporting
- Bachelor's Degree
- Data Entry
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Multitasking
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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