Regulatory Affairs Specialist Jobs in Devens, 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 Auditing & Compliance Analyst
- Waltham, MA (20 miles from Devens, MA)
- 3 days ago
- Waltham, MA (20 miles from Devens, MA)
- 3 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...
Sr Regulatory Compliance Specialist
- Worcester, MA (21 miles from Devens, MA)
- 4 days ago
- Worcester, MA (21 miles from Devens, MA)
- 4 days ago
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 (17 miles from Devens, MA)
- 5 days ago
- Framingham, MA (17 miles from Devens, MA)
- 5 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 WorkPrincipal Regulatory Affairs Specialist
- Waltham, MA (20 miles from Devens, MA)
- 8 days ago
- Waltham, MA (20 miles from Devens, 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...
- Chelmsford, MA (13 miles from Devens, MA)
- 9 days ago
- Chelmsford, MA (13 miles from Devens, 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...
- Marlborough, MA (13 miles from Devens, MA)
- 12 days ago
- Marlborough, MA (13 miles from Devens, MA)
- 12 days ago
Our Fortune 500 Medical Device client has an exciting opportunity for a Senior Regulatory Affairs Specialist (Sustaining)....
- Lexington, MA (20 miles from Devens, MA)
- 16 days ago
- Lexington, MA (20 miles from Devens, 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 IT Risk & Compliance Analyst
- Framingham, MA (17 miles from Devens, MA)
- 16 days ago
- Framingham, MA (17 miles from Devens, 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...
Regulatory Affairs Specialist, Biologics
- Tewksbury, MA (20 miles from Devens, MA)
- 21 days ago
- Tewksbury, MA (20 miles from Devens, MA)
- 21 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....
Sr Regulatory Affairs Specialist--Remote
- Marlborough, MA (13 miles from Devens, MA)
- 22 days ago
- Marlborough, MA (13 miles from Devens, MA)
- 22 days ago
JOIN A TEAM COMMITTED TO IMPROVING PATIENT CARE It takes a team of talented people to become one of the world's leading providers of innovative medical devices. AngioDynamics is dedicated to...
Remote Work- Billerica, MA (18 miles from Devens, MA)
- 45+ days ago
- Billerica, MA (18 miles from Devens, MA)
- 45+ 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...
Sr Regulatory Affairs Specialist
- Marlborough, MA (13 miles from Devens, MA)
- 30+ days ago
- Marlborough, MA (13 miles from Devens, MA)
- 30+ 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 (13 miles from Devens, MA)
- 30+ days ago
- Chelmsford, MA (13 miles from Devens, MA)
- 30+ 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...
Senior Regulatory Affairs Specialist
- Woburn, MA (23 miles from Devens, MA)
- 45+ days ago
- Woburn, MA (23 miles from Devens, MA)
- 45+ days ago
Affairs Specialist is responsible for: assisting with the preparation of regulatory submissions in order to obtain and maintain the necessary regulatory approvals/clearances/licenses, providing regulatory...
- Andover, MA (24 miles from Devens, MA)
- 45+ days ago
- Andover, MA (24 miles from Devens, MA)
- 45+ days ago
Who We Are Enel is a globally recognized leader in sustainable energy and is consistently named one of Fortune Magazine's "Companies that are Changing the World." It is also one of the largest and...
Demographic Data for Devens, MA
Moving to Devens, MA? Find some basic demographic data about Devens, MA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Devens, MA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Devens, 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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