Regulatory Affairs Specialist Jobs in Massachusetts
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.
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
- 1 day ago
- Boston, MA
- 1 day 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....
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,...
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...
Rise Baking Company was founded by bakery experts passionate about providing our customers with high quality products and providing a positive, collaborative place to work for our people. We are a...
Senior IT Risk & Compliance Analyst - Remote Available
- Framingham, MA
- 4 days ago
- Framingham, MA
- 4 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 WorkYour 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...
Systems standards and clinical investigations Solid understanding and knowledge of product development process, clinical development, manufacturing, and change control Demonstrated experience authoring...
Why This Role Stands Out: Impactful Work: Contribute significantly to the firms compliance infrastructure, particularly concerning US registered investment companies. Your expertise will support...
POSITION SUMMARY: The External Audit & Quality Assurance Compliance Analyst supports the organization's compliance program by coordinating external audits, ensuring adherence to regulatory...
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...
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...
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...
Responsibilities Related Affordable has an exciting career growth opportunity for an Affordable Housing Regulatory Compliance Specialist within our dynamic team. This position This position must...
A Day in the Life We are seeking a Senior Regulatory Affairs Specialist to join our team within Medtronic Acute Care and Monitoring (ACM)....
Demographic Data for Massachusetts
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Massachusetts
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Massachusetts 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
- Medicare
- Internal Control
- Management Reporting
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Validation
- 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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