Regulatory Affairs Specialist Jobs in Marblehead, 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 (24 miles from Marblehead, MA)
- 1 day ago
- Needham, MA (24 miles from Marblehead, MA)
- 1 day 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 (14 miles from Marblehead, MA)
- 1 day ago
- Boston, MA (14 miles from Marblehead, 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 WorkRegulatory Affairs Specialist, III
- Beverly, MA (4 miles from Marblehead, MA)
- 2 days ago
- Beverly, MA (4 miles from Marblehead, MA)
- 2 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 (18 miles from Marblehead, MA)
- 2 days ago
- Andover, MA (18 miles from Marblehead, 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!...
Fall 2025: Cybersecurity and Compliance Analyst Co-op
- Boston, MA (14 miles from Marblehead, MA)
- 2 days ago
- Boston, MA (14 miles from Marblehead, 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...
Principal Regulatory Compliance Specialist
- Danvers, MA (6 miles from Marblehead, MA)
- 2 days ago
- Danvers, MA (6 miles from Marblehead, MA)
- 2 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 (21 miles from Marblehead, MA)
- 3 days ago
- Waltham, MA (21 miles from Marblehead, 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 (15 miles from Marblehead, MA)
- 5 days ago
- Cambridge, MA (15 miles from Marblehead, MA)
- 5 days ago
ensure an effective Quality System is maintained....
Remote IT Quality Assurance and Compliance, Analyst
- Boston, MA (14 miles from Marblehead, MA)
- 10 days ago
- Boston, MA (14 miles from Marblehead, MA)
- 10 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 (14 miles from Marblehead, MA)
- 10 days ago
- Boston, MA (14 miles from Marblehead, MA)
- 10 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....
- Burlington, MA (17 miles from Marblehead, MA)
- 19 days ago
- Burlington, MA (17 miles from Marblehead, MA)
- 19 days ago
We are currently seeking a Regulatory Affairs Specialist to join our team....
Regulatory Affairs Specialist - Post Market
- Boston, MA (14 miles from Marblehead, MA)
- 26 days ago
- Boston, MA (14 miles from Marblehead, MA)
- 26 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 (14 miles from Marblehead, MA)
- 27 days ago
- Boston, MA (14 miles from Marblehead, 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...
Regulatory Affairs Specialist II
- Bedford, MA (20 miles from Marblehead, MA)
- 27 days ago
- Bedford, MA (20 miles from Marblehead, 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...
- Boston, MA (14 miles from Marblehead, MA)
- 29 days ago
- Boston, MA (14 miles from Marblehead, 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...
Demographic Data for Marblehead, MA
Moving to Marblehead, MA? Find some basic demographic data about Marblehead, MA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Marblehead, MA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Marblehead, 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
- Reimbursement
- Operations Analysis
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- Microsoft Visio
- FDA Regulations
- 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
- Sales
- Microsoft Excel
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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