Regulatory Affairs Specialist Jobs in Shirley, 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.
Regulatory Affairs Specialist (Hyrbid)
- Acton, MA (11 miles from Shirley, MA)
- 20 hours ago
- Acton, MA (11 miles from Shirley, MA)
- 20 hours ago
Understanding of 21 CFR 820, CMDR, ISO 13485, IEC 62304, ISO 14971, MDD, MDR....
Senior Regulatory Affairs Specialist (Memphis, TN)
- Andover, MA (24 miles from Shirley, MA)
- 2 days ago
- Andover, MA (24 miles from Shirley, MA)
- 2 days ago
We're looking for a Regulatory Affairs Specialist to join our team and drive regulatory strategies for our cutting-edge products. If you're ready to make an impact, apply now!...
- Waltham, MA (23 miles from Shirley, MA)
- 3 days ago
- Waltham, MA (23 miles from Shirley, MA)
- 3 days 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...
- Burlington, MA (22 miles from Shirley, MA)
- 18 days ago
- Burlington, MA (22 miles from Shirley, MA)
- 18 days ago
We are currently seeking a Regulatory Affairs Specialist to join our team....
Regulatory Affairs Specialist II
- Bedford, MA (19 miles from Shirley, MA)
- 27 days ago
- Bedford, MA (19 miles from Shirley, MA)
- 27 days ago
Regulatory Affairs Specialist II 3.1 3.1 out of 5 stars 180 Hartwell Road, Bedford, MA 01730 Overview: Position Summary: Responsible for domestic and/or international registration and renewal activities...
Sr Regulatory Affairs Specialist (Medical Device)
- Framingham, MA (20 miles from Shirley, MA)
- 30+ days ago
- Framingham, MA (20 miles from Shirley, MA)
- 30+ 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....
Regulatory Affairs Specialist (Austin, TX)
- Andover, MA (24 miles from Shirley, MA)
- 30+ days ago
- Andover, MA (24 miles from Shirley, MA)
- 30+ days ago
Knowledge of regulatory compliance requirements (e.g. 21 CFR 820, ISO13485:2016, EU MDR, GMP etc)....
Sr. Regulatory Compliance Specialist
- Marlborough, MA (16 miles from Shirley, MA)
- 30+ days ago
- Marlborough, MA (16 miles from Shirley, MA)
- 30+ days ago
Knowledge Deep understanding of global medical device regulatory frameworks and Quality Systems Management requirements....
Principal Regulatory Affairs Specialist
- Wilmington, MA (23 miles from Shirley, MA)
- 45+ days ago
- Wilmington, MA (23 miles from Shirley, MA)
- 45+ days ago
13485 standard and 21 CFR 820 regulation....
Export Sr. Trade Compliance Analyst
- Billerica, MA (19 miles from Shirley, MA)
- 60+ days ago
- Billerica, MA (19 miles from Shirley, MA)
- 60+ days ago
Be visionary Teledyne Technologies Incorporated provides enabling technologies for industrial growth markets that require advanced technology and high reliability. These markets include aerospace...
Demographic Data for Shirley, MA
Moving to Shirley, MA? Find some basic demographic data about Shirley, MA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Shirley, MA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Shirley, MA 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
- Reimbursement
- Operations Analysis
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- Microsoft Visio
- FDA Regulations
- Business Analysis
- Standard Operating Procedures
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- High School Diploma
- Investigation
- Written Communication
- Verbal Communication
- Data Analysis
- Education Experience
- Collaboration
- Documentation
- Reporting
- Filing
- Regulations
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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