Regulatory Affairs Specialist Jobs in Dorchester, 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, III
- Beverly, MA (21 miles from Dorchester, MA)
- 3 hours ago
- Beverly, MA (21 miles from Dorchester, MA)
- 3 hours ago
The role includes obtaining and maintaining regulatory approvals, supporting quality management system (QMS) objectives, and ensuring adherence to applicable regulatory standards....
Senior Regulatory Affairs Specialist (Memphis, TN)
- Andover, MA (23 miles from Dorchester, MA)
- 3 hours ago
- Andover, MA (23 miles from Dorchester, MA)
- 3 hours 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!...
Fall 2025: Cybersecurity and Compliance Analyst Co-op
- Boston, MA (3 miles from Dorchester, MA)
- 18 hours ago
- Boston, MA (3 miles from Dorchester, MA)
- 18 hours ago
Program Overview\: The Executive Office of Economic Development (EOED) is offering an exciting professional work experience for enthusiastic and motivated undergraduate and graduate students who...
Regulatory Affairs Specialist - ACM
- Mansfield, MA (21 miles from Dorchester, MA)
- 20 hours ago
- Mansfield, MA (21 miles from Dorchester, MA)
- 20 hours ago
A Day in the Life The Senior Regulatory Affairs Specialist (Sr....
Principal Regulatory Compliance Specialist
- Danvers, MA (19 miles from Dorchester, MA)
- 20 hours ago
- Danvers, MA (19 miles from Dorchester, MA)
- 20 hours 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 (10 miles from Dorchester, MA)
- 1 day ago
- Waltham, MA (10 miles from Dorchester, MA)
- 1 day 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...
Principal Regulatory Affairs Specialist
- Cambridge, MA (5 miles from Dorchester, MA)
- 3 days ago
- Cambridge, MA (5 miles from Dorchester, MA)
- 3 days ago
ensure an effective Quality System is maintained....
Environmental Compliance Analyst
- Avon, MA (12 miles from Dorchester, MA)
- 3 days ago
- Avon, MA (12 miles from Dorchester, MA)
- 3 days ago
Atlas is a nationwide leader in civil engineering, materials testing and geotechnical consulting services for environmental, industrial and infrastructure construction projects. Headquartered in...
- Boston, MA (3 miles from Dorchester, MA)
- 4 days ago
- Boston, MA (3 miles from Dorchester, MA)
- 4 days ago
C.H. Robinson is hiring a Compliance Analyst! In this position within Customs Compliance, you'll be responsible for developing a thorough understanding of import compliance related activities....
- Mansfield, MA (21 miles from Dorchester, MA)
- 7 days ago
- Mansfield, MA (21 miles from Dorchester, MA)
- 7 days ago
. + Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. + Leads or compiles all materials required...
Remote IT Quality Assurance and Compliance, Analyst
- Boston, MA (3 miles from Dorchester, MA)
- 8 days ago
- Boston, MA (3 miles from Dorchester, MA)
- 8 days ago
Come join our amazing team and work remote from home!** **What youll do:** Responsible for the timely and accurate response to audit and compliance requests for the enterprise while also ensuring...
Remote WorkPrincipal Regulatory Affairs Specialist
- Boston, MA (3 miles from Dorchester, MA)
- 8 days ago
- Boston, MA (3 miles from Dorchester, MA)
- 8 days ago
A Day in the Life As a Principal Regulatory Affairs Specialist at Medtronic, you will play a critical role in shaping the global regulatory strategy for innovative medical technologies....
Clinical Trial Regulatory Affairs Specialist
- Boston, MA (3 miles from Dorchester, MA)
- 13 days ago
- Boston, MA (3 miles from Dorchester, MA)
- 13 days ago
Clinical Trial Regulatory Affairs Specialist Location: Hybrid, Boston Area is preferred, but open to anywhere in the US Contract to Permanent Part-Time 10-20 hours per week to start then hours will...
Remote Work- Burlington, MA (15 miles from Dorchester, MA)
- 17 days ago
- Burlington, MA (15 miles from Dorchester, MA)
- 17 days ago
We are currently seeking a Regulatory Affairs Specialist to join our team....
Regulatory Affairs Specialist - Post Market
- Boston, MA (3 miles from Dorchester, MA)
- 24 days ago
- Boston, MA (3 miles from Dorchester, MA)
- 24 days ago
Regulatory Affairs Specialist - Post Market - req1434** **OVERVIEW** Reporting to the Director Regulatory Affairs, the Regulatory Affairs Specialist is responsible for complaint handling, coordination...
Remote WorkDemographic Data for Dorchester, MA
Moving to Dorchester, MA? Find some basic demographic data about Dorchester, MA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Dorchester, MA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Dorchester, MA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Environmental Compliance
- Geotechnical Engineering
- Civil Engineering
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- 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
- Implementation
- Analytical Skills
- High School Diploma
- Investigation
- Written Communication
- Verbal Communication
- Data Analysis
- Collaboration
- Documentation
- Reporting
- Education Experience
- Bachelor's Degree
- 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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