Regulatory Affairs Specialist Jobs in Dracut, 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.
Senior Risk & Compliance Analyst
- Salem, MA (23 miles from Dracut, MA)
- 4 days ago
- Salem, MA (23 miles from Dracut, MA)
- 4 days ago
Job Listing ID: 4305843 Job Title: Senior Risk & Compliance Analyst Application Deadline: Open Until FilledJob Location: Salem Date Posted: 07/05/2025Hours Worked Per Week: Not Provided Shift: Not...
Regulatory Affairs Specialist II
- Waltham, MA (20 miles from Dracut, MA)
- 4 days ago
- Waltham, MA (20 miles from Dracut, MA)
- 4 days ago
Nova Biomedical is hiring a Regulatory Affairs Specialist II to join our team in Waltham, MA....
Regulatory Affairs Specialist (Hyrbid)
- Acton, MA (13 miles from Dracut, MA)
- 10 days ago
- Acton, MA (13 miles from Dracut, MA)
- 10 days ago
Understanding of 21 CFR 820, CMDR, ISO 13485, IEC 62304, ISO 14971, MDD, MDR....
Regulatory Affairs Specialist, III
- Beverly, MA (24 miles from Dracut, MA)
- 11 days ago
- Beverly, MA (24 miles from Dracut, MA)
- 11 days ago
In-depth knowledge of ISO 13485, FDA regulations (including 21 CFR Part 820), and EU MDR. Knowledge of ISO 14971 risk management for medical devices....
Senior Regulatory Affairs Specialist (Memphis, TN)
- Andover, MA (7 miles from Dracut, MA)
- 11 days ago
- Andover, MA (7 miles from Dracut, MA)
- 11 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!...
Principal Regulatory Compliance Specialist
- Danvers, MA (19 miles from Dracut, MA)
- 12 days ago
- Danvers, MA (19 miles from Dracut, MA)
- 12 days ago
Provide internal audit inputs/updates to Quality System Management Reviews to allow meaningful review of their tasks. Participate in JJRC audits as requested....
- Waltham, MA (20 miles from Dracut, MA)
- 13 days ago
- Waltham, MA (20 miles from Dracut, MA)
- 13 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 (13 miles from Dracut, MA)
- 28 days ago
- Burlington, MA (13 miles from Dracut, MA)
- 28 days ago
We are currently seeking a Regulatory Affairs Specialist to join our team....
Regulatory Affairs Specialist II
- Bedford, MA (13 miles from Dracut, MA)
- 30+ days ago
- Bedford, MA (13 miles from Dracut, MA)
- 30+ 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...
Regulatory Affairs Specialist (Austin, TX)
- Andover, MA (7 miles from Dracut, MA)
- 30+ days ago
- Andover, MA (7 miles from Dracut, MA)
- 30+ days ago
Knowledge of regulatory compliance requirements (e.g. 21 CFR 820, ISO13485:2016, EU MDR, GMP etc)....
Coding/Billing Compliance Analyst
- Somerville, MA (23 miles from Dracut, MA)
- 30+ days ago
- Somerville, MA (23 miles from Dracut, MA)
- 30+ days ago
Site: Mass General Brigham Incorporated Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to...
- Cambridge, MA (23 miles from Dracut, MA)
- 45+ days ago
- Cambridge, MA (23 miles from Dracut, MA)
- 45+ days ago
Compliance Analyst Job details Posted 27 May 2025 Location Cambridge, MA Job type Permanent Reference 965817 Job description Job Title: Compliance Analyst Location : Cambridge MA Contract : (6...
- Cambridge, MA (23 miles from Dracut, MA)
- 45+ days ago
- Cambridge, MA (23 miles from Dracut, MA)
- 45+ days ago
Compliance Analyst Location: Cambridge, MA (Hybrid) Join our client's dynamic team as a Compliance Analyst in the Global Ethics & Compliance Department. This role is perfect for someone who is...
- Cambridge, MA (23 miles from Dracut, MA)
- 45+ days ago
- Cambridge, MA (23 miles from Dracut, MA)
- 45+ days ago
USA - Compliance Analyst#25-58860 Cambridge, MA All On-site Job Description Top skills needed: Compliance monitoring Minimum 5 years pharma/medical device company Cambridge, MA OBJECTIVES/PURPOSE...
Principal Regulatory Affairs Specialist
- Wilmington, MA (11 miles from Dracut, MA)
- 60+ days ago
- Wilmington, MA (11 miles from Dracut, MA)
- 60+ days ago
13485 standard and 21 CFR 820 regulation....
Demographic Data for Dracut, MA
Moving to Dracut, MA? Find some basic demographic data about Dracut, MA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Dracut, MA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Dracut, 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
- 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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