Regulatory Affairs Specialist Jobs in Northborough, 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 Regulatory Affairs Specialist
- Marlborough, MA (4 miles from Northborough, MA)
- 3 days ago
- Marlborough, MA (4 miles from Northborough, MA)
- 3 days ago
Support quality system audits by notified bodies, government agencies and customers....
Regulatory Operations Specialist (Contract)
- Framingham, MA (10 miles from Northborough, MA)
- 7 days ago
- Framingham, MA (10 miles from Northborough, MA)
- 7 days ago
Company Overview Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a...
Principal Regulatory Affairs Specialist, Digital Technology
- Lexington, MA (23 miles from Northborough, MA)
- 7 days ago
- Lexington, MA (23 miles from Northborough, MA)
- 7 days ago
Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions,...
Sr. Controls & SOX Compliance Analyst
- Waltham, MA (19 miles from Northborough, MA)
- 7 days ago
- Waltham, MA (19 miles from Northborough, MA)
- 7 days ago
Qualifications Min 5+ years of experience in SOX compliance, internal audit, or risk management, preferably within a global public company or Big 4 firm....
Senior Staff IT Risk & Compliance Analyst - Remote available
- Framingham, MA (10 miles from Northborough, MA)
- 9 days ago
- Framingham, MA (10 miles from Northborough, MA)
- 9 days ago
TJX Companies At TJX Companies, every day brings new opportunities for growth, exploration, and achievement. You'll be part of our vibrant team that embraces diversity, fosters collaboration, and...
Remote WorkExport Sr. Trade Compliance Analyst
- Billerica, MA (24 miles from Northborough, MA)
- 11 days ago
- Billerica, MA (24 miles from Northborough, MA)
- 11 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...
Senior Staff IT Risk & Compliance Analyst
- Framingham, MA (10 miles from Northborough, MA)
- 14 days ago
- Framingham, MA (10 miles from Northborough, MA)
- 14 days ago
TJX Companies At TJX Companies, every day brings new opportunities for growth, exploration, and achievement. Youll be part of our vibrant team that embraces diversity, fosters collaboration, and...
Senior Auditing & Compliance Analyst
- Waltham, MA (19 miles from Northborough, MA)
- 22 days ago
- Waltham, MA (19 miles from Northborough, MA)
- 22 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...
Senior IT Risk & Compliance Analyst - Remote Available
- Framingham, MA (10 miles from Northborough, MA)
- 24 days ago
- Framingham, MA (10 miles from Northborough, MA)
- 24 days ago
TJX Companies Chez TJX Companies, chaque jour apporte de nouvelles occasions de croissance, de decouverte et d'accomplissement. Vous ferez partie d'une equipe dynamique qui prone la diversite,...
Remote Work- Lexington, MA (23 miles from Northborough, MA)
- 30+ days ago
- Lexington, MA (23 miles from Northborough, 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...
Senior IT Risk & Compliance Analyst
- Framingham, MA (10 miles from Northborough, MA)
- 30+ days ago
- Framingham, MA (10 miles from Northborough, MA)
- 30+ days ago
TJX Companies At TJX Companies, every day brings new opportunities for growth, exploration, and achievement. Youll be part of our vibrant team that embraces diversity, fosters collaboration, and...
Sr Regulatory Affairs Specialist
- Marlborough, MA (4 miles from Northborough, MA)
- 45+ days ago
- Marlborough, MA (4 miles from Northborough, MA)
- 45+ days ago
JOB SUMMARY – To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Responsible for determining the path to market for new and modifications...
- Chelmsford, MA (22 miles from Northborough, MA)
- 45+ days ago
- Chelmsford, MA (22 miles from Northborough, MA)
- 45+ 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...
Demographic Data for Northborough, MA
Moving to Northborough, MA? Find some basic demographic data about Northborough, MA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Northborough, MA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Northborough, 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
- Internal Control
- Reimbursement
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Resolution
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Process Improvement
- Military Background
- Implementation
- Analytical Skills
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- 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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