Regulatory Affairs Specialist Jobs in Andover, 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.
- Boston, MA (20 miles from Andover, MA)
- 22 hours ago
- Boston, MA (20 miles from Andover, MA)
- 22 hours ago
Otsuka Pharmaceuticals - Trade Compliance Analyst** **Position Summary:** + Provide technical and analytical support for customs and trade compliance matters at the North Americasite/division(s)...
Senior Security Trust & Compliance Analyst
- Boston, MA (20 miles from Andover, MA)
- 1 day ago
- Boston, MA (20 miles from Andover, MA)
- 1 day ago
At Klaviyo, we value the unique backgrounds, experiences and perspectives each Klaviyo (we call ourselves Klaviyos) brings to our workplace each and every day. We believe everyone deserves a fair...
Principal Regulatory Affairs Specialist, Pharmaceutical Products (Hybrid)
- Boston, MA (20 miles from Andover, MA)
- 2 days ago
- Boston, MA (20 miles from Andover, MA)
- 2 days ago
We are currently seeking a **Principal Regulatory Affairs Specialist,** ( **Pharmaceutical Products** ) to join our **Medical** Division. This is a Hybrid role based in Cary, Illinois....
Operational Risk and Compliance Analyst
- Boston, MA (20 miles from Andover, MA)
- 3 days ago
- Boston, MA (20 miles from Andover, MA)
- 3 days ago
Who we are looking for State Streets Global Credit Finance (GCF) division has established an Operational Risk and Compliance function which adds value to the business in the identification,...
Senior Auditing & Compliance Analyst
- Waltham, MA (18 miles from Andover, MA)
- 4 days ago
- Waltham, MA (18 miles from Andover, MA)
- 4 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...
- Boston, MA (20 miles from Andover, MA)
- 7 days ago
- Boston, MA (20 miles from Andover, MA)
- 7 days ago
Your Future Evolves Here** Evolent partners with health plans and providers to achieve better outcomes for people with most complex and costly health conditions. Working across specialties and...
Principal Regulatory Affairs Specialist
- Waltham, MA (18 miles from Andover, MA)
- 8 days ago
- Waltham, MA (18 miles from Andover, MA)
- 8 days ago
Systems standards and clinical investigations Solid understanding and knowledge of product development process, clinical development, manufacturing, and change control Demonstrated experience authoring...
Senior Regulatory Compliance Analyst
- Boston, MA (20 miles from Andover, MA)
- 8 days ago
- Boston, MA (20 miles from Andover, MA)
- 8 days ago
Why This Role Stands Out: Impactful Work: Contribute significantly to the firms compliance infrastructure, particularly concerning US registered investment companies. Your expertise will support...
External Audit & Quality Assurance Compliance Analyst
- Boston, MA (20 miles from Andover, MA)
- 9 days ago
- Boston, MA (20 miles from Andover, MA)
- 9 days ago
POSITION SUMMARY: The External Audit & Quality Assurance Compliance Analyst supports the organization's compliance program by coordinating external audits, ensuring adherence to regulatory...
- Chelmsford, MA (10 miles from Andover, MA)
- 9 days ago
- Chelmsford, MA (10 miles from Andover, MA)
- 9 days ago
Brooks is a leading provider of automation solutions with over 40 years of experience in the semiconductor industry, offering precision robotics, integrated automation systems, and contamination...
Lending Compliance Analyst Massachusetts Institute of Technology (MIT)
- Cambridge, MA (18 miles from Andover, MA)
- 15 days ago
- Cambridge, MA (18 miles from Andover, MA)
- 15 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 (13 miles from Andover, MA)
- 16 days ago
- Lexington, MA (13 miles from Andover, MA)
- 16 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 Risk & Compliance Analyst
- Salem, MA (16 miles from Andover, MA)
- 17 days ago
- Salem, MA (16 miles from Andover, MA)
- 17 days ago
Job Listing ID: 4241186 Job Title: Senior Risk & Compliance Analyst Application Deadline: Open Until FilledJob Location: Salem Date Posted: 03/29/2025Hours Worked Per Week: Not Provided Shift: Not...
Coding/Billing Compliance Analyst
- Somerville, MA (18 miles from Andover, MA)
- 18 days ago
- Somerville, MA (18 miles from Andover, MA)
- 18 days ago
Site: Mass General Brigham Incorporated At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our mission-from doctors, nurses, business people and tech...
Regulatory Affairs Specialist, Biologics
- Tewksbury, MA (4 miles from Andover, MA)
- 22 days ago
- Tewksbury, MA (4 miles from Andover, MA)
- 22 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....
Demographic Data for Andover, MA
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Andover, MA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Andover, 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
- Medicaid
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Management Reporting
- Fraud Investigation
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Medical Device Sales
- FDA Regulations
- Business Processes
- Document Management
- Microsoft Visio
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Reporting
- Data Analysis
- Education Experience
- Interpersonal Skills
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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