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.
- Cambridge, MA (23 miles from Dracut, MA)
- 9 hours ago
- Cambridge, MA (23 miles from Dracut, MA)
- 9 hours 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...
Sr Risk & Compliance Analyst (Remote - EST Preferred)
- Salem, MA (23 miles from Dracut, MA)
- 4 days ago
- Salem, MA (23 miles from Dracut, MA)
- 4 days ago
Job Listing ID: 4268220 Job Title: Sr Risk & Compliance Analyst (Remote - EST Preferred) Application Deadline: Open Until FilledJob Location: Salem Date Posted: 05/09/2025Hours Worked Per Week:...
Remote WorkBenefit Contracts & 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: 4268650 Job Title: Benefit Contracts & Compliance Analyst Application Deadline: 06/08/2025Job Location: Salem Date Posted: 05/09/2025Hours Worked Per Week: 32 Shift: Day Shift...
Remote WorkPrincipal Regulatory Affairs Specialist
- Wilmington, MA (11 miles from Dracut, MA)
- 9 days ago
- Wilmington, MA (11 miles from Dracut, MA)
- 9 days ago
CFR 820 regulation....
- Salem, MA (23 miles from Dracut, MA)
- 15 days ago
- Salem, MA (23 miles from Dracut, MA)
- 15 days ago
Own audit readiness and guide teams through federal and state exams, internal audits, and testing processes with confidence and clarity....
Remote WorkExport Sr. Trade Compliance Analyst
- Billerica, MA (10 miles from Dracut, MA)
- 19 days ago
- Billerica, MA (10 miles from Dracut, MA)
- 19 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...
Medicare Compliance Analyst II or III
- Salem, MA (23 miles from Dracut, MA)
- 21 days ago
- Salem, MA (23 miles from Dracut, MA)
- 21 days ago
Job Listing ID: 4258095 Job Title: Medicare Compliance Analyst II or III Application Deadline: 05/23/2025Job Location: Salem Date Posted: 04/23/2025Hours Worked Per Week: 32 Shift: Day Shift...
Remote WorkSenior Auditing & Compliance Analyst
- Waltham, MA (20 miles from Dracut, MA)
- 30+ days ago
- Waltham, MA (20 miles from Dracut, MA)
- 30+ days ago
The Compliance Analyst, Health & Regulatory Compliance Group will support all members of the Health Regulatory & Compliance Group with managing multiple activities and projects required for...
Lending Compliance Analyst Massachusetts Institute of Technology (MIT)
- Cambridge, MA (23 miles from Dracut, MA)
- 30+ days ago
- Cambridge, MA (23 miles from Dracut, MA)
- 30+ days ago
LENDING COMPLIANCE ANALYST, Credit Union, will support, implement, and monitor the end-to-end internal compliance audit monitoring program for the Consumer and Lending departments to ensure...
- Lexington, MA (16 miles from Dracut, MA)
- 30+ days ago
- Lexington, MA (16 miles from Dracut, MA)
- 30+ days ago
LENDING COMPLIANCE ANALYST, Credit Union, will support, implement, and monitor the end-to-end internal compliance audit monitoring program for the Consumer and Lending departments to ensure...
Regulatory Affairs Specialist, Biologics
- Tewksbury, MA (6 miles from Dracut, MA)
- 45+ days ago
- Tewksbury, MA (6 miles from Dracut, MA)
- 45+ days ago
Experience with FDA 21 CFR 820, ISO 13485, and ISO 9001. Proficiency with Microsoft Office tools, eCTD software, Adobe Acrobat, and working knowledge of QMS systems....
Senior Regulatory Affairs Specialist
- Manchester, NH (21 miles from Dracut, MA)
- 45+ days ago
- Manchester, NH (21 miles from Dracut, MA)
- 45+ days ago
Overview Our goal is to improve lives by restoring or replacing the function of damaged cells, tissues, and organs for patients. BioFabUSA's mission is to develop a highly diverse, competitive,...
- Chelmsford, MA (7 miles from Dracut, MA)
- 60+ days ago
- Chelmsford, MA (7 miles from Dracut, MA)
- 60+ days ago
Regulatory Affairs Specialist (SRA) will develop US, EU, and Canada strategies, assessments and submissions for complex projects and review issues related to regulatory documents, investigations, product...
- Andover, MA (7 miles from Dracut, MA)
- 60+ days ago
- Andover, MA (7 miles from Dracut, MA)
- 60+ days ago
Who We Are Enel is a globally recognized leader in sustainable energy and is consistently named one of Fortune Magazine's "Companies that are Changing the World." It is also one of the largest and...
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
- Internal Control
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- Business Processes
- Document Management
- FDA Regulations
- Resolution
- Product Development
- Affirmative Action
- Engineering
- Risk Management
- Strategy Development
- Process Improvement
- Military Background
- Auditing
- Analytical Skills
- Implementation
- Investigation
- Verbal Communication
- Written Communication
- Documentation
- Data Analysis
- Collaboration
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Reporting
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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