Regulatory Affairs Specialist Jobs in Harvard, 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.
Regulatory Affairs Specialist II
- Waltham, MA (17 miles from Harvard, MA)
- 3 days ago
- Waltham, MA (17 miles from Harvard, MA)
- 3 days ago
Nova Biomedical is hiring a Regulatory Affairs Specialist II to join our team in Waltham, MA....
Principal Compliance Analyst, Global Audit & Monitoring
- Marlborough, MA (10 miles from Harvard, MA)
- 4 days ago
- Marlborough, MA (10 miles from Harvard, MA)
- 4 days ago
Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, well give you the opportunity to harness all thats...
- Needham, MA (22 miles from Harvard, MA)
- 7 days ago
- Needham, MA (22 miles from Harvard, MA)
- 7 days ago
Department: Affordable Housing | Equity - Asset Management We are Walker & Dunlop. We are one of the largest providers of capital to the commercial real estate industry, enabling real estate...
Remote WorkRegulatory Affairs Specialist (Hyrbid)
- Acton, MA (7 miles from Harvard, MA)
- 8 days ago
- Acton, MA (7 miles from Harvard, MA)
- 8 days ago
Understanding of 21 CFR 820, CMDR, ISO 13485, IEC 62304, ISO 14971, MDD, MDR....
- Needham, MA (22 miles from Harvard, MA)
- 9 days ago
- Needham, MA (22 miles from Harvard, MA)
- 9 days 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...
Senior Regulatory Affairs Specialist (Memphis, TN)
- Andover, MA (23 miles from Harvard, MA)
- 9 days ago
- Andover, MA (23 miles from Harvard, MA)
- 9 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!...
- Waltham, MA (17 miles from Harvard, MA)
- 11 days ago
- Waltham, MA (17 miles from Harvard, MA)
- 11 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 (24 miles from Harvard, MA)
- 13 days ago
- Cambridge, MA (24 miles from Harvard, MA)
- 13 days ago
ensure an effective Quality System is maintained....
- Burlington, MA (19 miles from Harvard, MA)
- 26 days ago
- Burlington, MA (19 miles from Harvard, MA)
- 26 days ago
We are currently seeking a Regulatory Affairs Specialist to join our team....
Regulatory Affairs Specialist II
- Bedford, MA (15 miles from Harvard, MA)
- 30+ days ago
- Bedford, MA (15 miles from Harvard, MA)
- 30+ 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...
Sr Regulatory Affairs Specialist (Medical Device)
- Framingham, MA (14 miles from Harvard, MA)
- 30+ days ago
- Framingham, MA (14 miles from Harvard, MA)
- 30+ days ago
Our client is currently seeking a Senior Regulatory Affairs Specialist. This is a permanent, direct hire, fully on-site position. Medical Device experience required....
Regulatory Affairs Specialist (Austin, TX)
- Andover, MA (23 miles from Harvard, MA)
- 30+ days ago
- Andover, MA (23 miles from Harvard, MA)
- 30+ days ago
Knowledge of regulatory compliance requirements (e.g. 21 CFR 820, ISO13485:2016, EU MDR, GMP etc)....
- Cambridge, MA (24 miles from Harvard, MA)
- 45+ days ago
- Cambridge, MA (24 miles from Harvard, MA)
- 45+ days ago
Compliance Analyst Job details Posted 27 May 2025 Location Cambridge, MA Job type Permanent Reference 965817 Job description Job Title: Compliance Analyst Location : Cambridge MA Contract : (6...
- Cambridge, MA (24 miles from Harvard, MA)
- 45+ days ago
- Cambridge, MA (24 miles from Harvard, MA)
- 45+ days ago
Compliance Analyst Location: Cambridge, MA (Hybrid) Join our client's dynamic team as a Compliance Analyst in the Global Ethics & Compliance Department. This role is perfect for someone who is...
- Cambridge, MA (24 miles from Harvard, MA)
- 45+ days ago
- Cambridge, MA (24 miles from Harvard, MA)
- 45+ days ago
USA - Compliance Analyst#25-58860 Cambridge, MA All On-site Job Description Top skills needed: Compliance monitoring Minimum 5 years pharma/medical device company Cambridge, MA OBJECTIVES/PURPOSE...
Demographic Data for Harvard, MA
Moving to Harvard, MA? Find some basic demographic data about Harvard, MA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Harvard, MA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Harvard, 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
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Standard Operating Procedures
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- Investigation
- Written Communication
- Verbal Communication
- Education Experience
- Data Analysis
- Collaboration
- Documentation
- Reporting
- Filing
- Regulations
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Sales
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Leadership
- Communication Skills
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