Regulatory Affairs Specialist Jobs in Brockton, 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.
- Needham, MA (17 miles from Brockton, MA)
- 22 hours ago
- Needham, MA (17 miles from Brockton, MA)
- 22 hours ago
This is a hybrid position based in Needham. Onsite presence of 1-2 days/week is expected. All candidates must live within commuting distance to office. Why Work With Us? At Candel, our people...
Compliance Analyst III (Remote US)
- Boston, MA (19 miles from Brockton, MA)
- 1 day ago
- Boston, MA (19 miles from Brockton, MA)
- 1 day ago
WM, a Fortune 250 company, is the leading provider of comprehensive waste and environmental services in North America. We are strongly committed to a foundation of operating excellence,...
Remote WorkFall 2025: Cybersecurity and Compliance Analyst Co-op
- Boston, MA (19 miles from Brockton, MA)
- 2 days ago
- Boston, MA (19 miles from Brockton, MA)
- 2 days 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 (10 miles from Brockton, MA)
- 2 days ago
- Mansfield, MA (10 miles from Brockton, MA)
- 2 days ago
A Day in the Life The Senior Regulatory Affairs Specialist (Sr....
- Waltham, MA (24 miles from Brockton, MA)
- 3 days ago
- Waltham, MA (24 miles from Brockton, 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...
Principal Regulatory Affairs Specialist
- Cambridge, MA (21 miles from Brockton, MA)
- 5 days ago
- Cambridge, MA (21 miles from Brockton, MA)
- 5 days ago
ensure an effective Quality System is maintained....
Principal Regulatory Affairs Specialist
- Plymouth, MA (24 miles from Brockton, MA)
- 6 days ago
- Plymouth, MA (24 miles from Brockton, MA)
- 6 days ago
You have expertise in understanding, interpretation, and application of FDA 21 CFR 820 Quality System Regulation, EU MDR Regulation 2017/745, ISO 13485, and other relevant standards and regulations....
Remote IT Quality Assurance and Compliance, Analyst
- Boston, MA (19 miles from Brockton, MA)
- 9 days ago
- Boston, MA (19 miles from Brockton, MA)
- 9 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 (19 miles from Brockton, MA)
- 9 days ago
- Boston, MA (19 miles from Brockton, MA)
- 9 days ago
Apply in-depth knowledge of FDA regulations, EU Medical Device Directive (93/42/EEC), Medical Device Regulation (EU 2017/745), ISO 14971, ISO 13485, and other international regulatory frameworks....
Regulatory Affairs Specialist - Post Market
- Boston, MA (19 miles from Brockton, MA)
- 25 days ago
- Boston, MA (19 miles from Brockton, MA)
- 25 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 WorkPortfolio Compliance Analyst - CLO/SMA products
- Boston, MA (19 miles from Brockton, MA)
- 27 days ago
- Boston, MA (19 miles from Brockton, MA)
- 27 days ago
As a leading financial services and healthcare technology company based on revenue, SS&C is headquartered in Windsor, Connecticut, and has 27,000+ employees in 35 countries. Some 20,000 financial...
Senior Regulatory Affairs Specialist
- Canton, MA (8 miles from Brockton, MA)
- 27 days ago
- Canton, MA (8 miles from Brockton, MA)
- 27 days ago
Ensuring regulatory compliance with QSR/ISO 13485, cGCP, and cGMP requirements and stay apprised of ICH, FDA, and EU requirements....
- Norwood, MA (10 miles from Brockton, MA)
- 29 days ago
- Norwood, MA (10 miles from Brockton, MA)
- 29 days ago
The Senior Compliance Analyst will actively participate in the Compliance Departments mission to prevent, detect, and manage consumer compliance risk. The Senior Compliance Analyst will monitor...
- Boston, MA (19 miles from Brockton, MA)
- 29 days ago
- Boston, MA (19 miles from Brockton, MA)
- 29 days ago
Who we are Zus is a shared health data platform designed to accelerate healthcare data interoperability by providing easy-to-use patient data via API, embedded components, and direct EHR...
Coding/Billing Compliance Analyst
- Somerville, MA (21 miles from Brockton, MA)
- 30+ days ago
- Somerville, MA (21 miles from Brockton, 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...
Demographic Data for Brockton, MA
Moving to Brockton, MA? Find some basic demographic data about Brockton, MA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Brockton, MA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Brockton, MA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Vendor Management
- Reimbursement
- 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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