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.
- Lexington, MA (20 miles from Devens, MA)
- 15 hours ago
- Lexington, MA (20 miles from Devens, MA)
- 15 hours ago
Knowledge of compliance with key international standards, such as ISO 13485 and ISO 14971 Demonstrate excellent communication skills Demonstrate strong organizational skills, including the ability to...
Remote WorkSenior Regulatory Affairs Specialist
- Marlborough, MA (13 miles from Devens, MA)
- 10 days ago
- Marlborough, MA (13 miles from Devens, MA)
- 10 days ago
Senior Regulatory Affairs Specialist Newark, DE, United States Marlborough, MA, United States **Join us as a Regulatory Affairs SpecialistSustaining, and play a pivotal role in supporting and improving...
- Andover, MA (24 miles from Devens, MA)
- 16 days ago
- Andover, MA (24 miles from Devens, MA)
- 16 days ago
Who We Are Enel North America is a proven renewables leader delivering clean, flexible and sustainable energy solutions. As part of the Enel Group, we develop, build, own and operate renewable...
Regulatory Affairs Specialist II
- Waltham, MA (20 miles from Devens, MA)
- 24 days ago
- Waltham, MA (20 miles from Devens, MA)
- 24 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 (13 miles from Devens, MA)
- 25 days ago
- Marlborough, MA (13 miles from Devens, MA)
- 25 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...
Regulatory Affairs Specialist (Hyrbid)
- Acton, MA (9 miles from Devens, MA)
- 29 days ago
- Acton, MA (9 miles from Devens, MA)
- 29 days ago
Understanding of 21 CFR 820, CMDR, ISO 13485, IEC 62304, ISO 14971, MDD, MDR....
- Burlington, MA (20 miles from Devens, MA)
- 45+ days ago
- Burlington, MA (20 miles from Devens, MA)
- 45+ days ago
We are currently seeking a Regulatory Affairs Specialist to join our team....
Regulatory Affairs Specialist (Austin, TX)
- Andover, MA (24 miles from Devens, MA)
- 60+ days ago
- Andover, MA (24 miles from Devens, MA)
- 60+ days ago
Knowledge of regulatory compliance requirements (e.g. 21 CFR 820, ISO13485:2016, EU MDR, GMP etc)....
Principal Regulatory Affairs Specialist
- Wilmington, MA (22 miles from Devens, MA)
- 60+ days ago
- Wilmington, MA (22 miles from Devens, MA)
- 60+ days ago
13485 standard and 21 CFR 820 regulation....
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
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Business Processes
- Medical Device Sales
- FDA Regulations
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Process Improvement
- Auditing
- Military Background
- Implementation
- Analytical Skills
- Investigation
- Written Communication
- Education Experience
- Verbal Communication
- Documentation
- Data Analysis
- Reporting
- Collaboration
- Interpersonal Skills
- Filing
- Microsoft PowerPoint
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Sales
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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