Regulatory Affairs Specialist Jobs in Cambridge, 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.
Info Security Compliance Analyst Boston College
- Chestnut Hill, MA (4 miles from Cambridge, MA)
- 8 hours ago
- Chestnut Hill, MA (4 miles from Cambridge, MA)
- 8 hours ago
Boston College Introduction Founded in 1863, Boston College is a Jesuit, Catholic university located six miles from downtown Boston with an enrollment of 9,484 full-time undergraduates and 5,250...
Info Security Compliance Analyst
- Chestnut Hill, MA (4 miles from Cambridge, MA)
- 1 day ago
- Chestnut Hill, MA (4 miles from Cambridge, MA)
- 1 day ago
Boston College Introduction Founded in 1863, Boston College is a Jesuit, Catholic university located six miles from downtown Boston with an enrollment of 9,484 full-time undergraduates and 5,250...
Principal Regulatory Affairs Specialist
- Wilmington, MA (12 miles from Cambridge, MA)
- 3 days ago
- Wilmington, MA (12 miles from Cambridge, MA)
- 3 days ago
CFR 820 regulation....
- Boston, MA (3 miles from Cambridge, MA)
- 4 days ago
- Boston, MA (3 miles from Cambridge, MA)
- 4 days ago
The Information Security Compliance Analyst will work to ensure the organization maintains its compliance to external customer and regulatory requirements. The Information Security Compliance...
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Research Regulatory Compliance Specialist
- Brookline, MA (4 miles from Cambridge, MA)
- 5 days ago
- Brookline, MA (4 miles from Cambridge, MA)
- 5 days ago
The Rosamund Stone Zander Translational Neuroscience Center (RSZ TNC) is seeking a dynamic and innovative Research Regulatory Compliance Specialist to join our team. The RSZ TNC strives to improve...
Senior Regulatory Affairs Specialist
- Marlborough, MA (21 miles from Cambridge, MA)
- 5 days ago
- Marlborough, MA (21 miles from Cambridge, MA)
- 5 days ago
Support quality system audits by notified bodies, government agencies and customers....
Regulatory Operations Specialist (Contract)
- Framingham, MA (15 miles from Cambridge, MA)
- 9 days ago
- Framingham, MA (15 miles from Cambridge, MA)
- 9 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...
- Salem, MA (14 miles from Cambridge, MA)
- 9 days ago
- Salem, MA (14 miles from Cambridge, MA)
- 9 days ago
Own audit readiness and guide teams through federal and state exams, internal audits, and testing processes with confidence and clarity....
Remote WorkSenior Staff IT Risk & Compliance Analyst - Remote available
- Framingham, MA (15 miles from Cambridge, MA)
- 11 days ago
- Framingham, MA (15 miles from Cambridge, MA)
- 11 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 WorkLease Compliance Analyst - Office of Real Estate Management
- Boston, MA (3 miles from Cambridge, MA)
- 13 days ago
- Boston, MA (3 miles from Cambridge, MA)
- 13 days ago
Lease Compliance Analyst - Office of Real Estate Management (250001FA) Job Description Lease Compliance Analyst - Office of Real Estate Management - (250001FA) Description DCAMM'S Mission The...
- Boston, MA (3 miles from Cambridge, MA)
- 14 days ago
- Boston, MA (3 miles from Cambridge, MA)
- 14 days ago
. + Own audit readiness and guide teams through federal and state exams, internal audits, and testing processes with confidence and clarity. + Turn insights into action by analyzing results, delivering...
Remote WorkExport Sr. Trade Compliance Analyst
- Billerica, MA (13 miles from Cambridge, MA)
- 14 days ago
- Billerica, MA (13 miles from Cambridge, MA)
- 14 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...
- Boston, MA (3 miles from Cambridge, MA)
- 15 days ago
- Boston, MA (3 miles from Cambridge, MA)
- 15 days ago
Guided by our company Purpose of "Inspiring well-being for our colleagues, consumers, and communities," we are committed to building a best-in-class Law Department. We drive a high-performance...
Medicare Compliance Analyst II or III
- Salem, MA (14 miles from Cambridge, MA)
- 15 days ago
- Salem, MA (14 miles from Cambridge, MA)
- 15 days ago
Job Listing ID: 4258095 Job Title: Medicare Compliance Analyst II or III Application Deadline: 05/23/2025Job Location: Salem Date Posted: 04/23/2025Hours Worked Per Week: 32 Shift: Day Shift...
Remote WorkSenior Staff IT Risk & Compliance Analyst
- Framingham, MA (15 miles from Cambridge, MA)
- 16 days ago
- Framingham, MA (15 miles from Cambridge, MA)
- 16 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...
Demographic Data for Cambridge, MA
Moving to Cambridge, MA? Find some basic demographic data about Cambridge, MA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Cambridge, MA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Cambridge, 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
- Risk Management
- Affirmative Action
- Engineering
- 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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