Regulatory Affairs Specialist Jobs in Lexington, 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.
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 WorkPrincipal Regulatory Compliance Specialist
- Danvers, MA (15 miles from Lexington, MA)
- 19 hours ago
- Danvers, MA (15 miles from Lexington, MA)
- 19 hours ago
Provide internal audit inputs/updates to Quality System Management Reviews to allow meaningful review of their tasks. Participate in JJRC audits as requested....
- Boston, MA (10 miles from Lexington, MA)
- 1 day ago
- Boston, MA (10 miles from Lexington, MA)
- 1 day ago
About Us Wellington Management offers comprehensive investment management capabilities that span nearly all segments of the global capital markets. Our investment solutions, tailored to the unique...
Remote Work- Boston, MA (10 miles from Lexington, MA)
- 1 day ago
- Boston, MA (10 miles from Lexington, MA)
- 1 day ago
Sungage Financial has revolutionized the residential solar industry by offering the lowest monthly payments in the solar financing industry. Our lean team of professionals quickly adapts to the...
Principal Reg Affairs Specialist
- Boston, MA (10 miles from Lexington, MA)
- 2 days ago
- Boston, MA (10 miles from Lexington, MA)
- 2 days ago
A Day in the Life Job Summary: Principal Regulatory Affairs Specialist As a Principal Regulatory Affairs Specialist, you will play a key role in ensuring regulatory compliance and supporting the global...
- Boston, MA (10 miles from Lexington, MA)
- 2 days ago
- Boston, MA (10 miles from Lexington, MA)
- 2 days ago
Our mission is to make higher education accessible and affordable for everyone.** We empower students with financial support and supercharge their ability to pay down their debt, so they can get...
Remote WorkInternal Audit/SOX Compliance Analyst II
- Boston, MA (10 miles from Lexington, MA)
- 2 days ago
- Boston, MA (10 miles from Lexington, MA)
- 2 days ago
Support the SOX program by performing control testing, including walkthroughs and evaluating the design and operational effectiveness of controls.... Coordinate SOX program testing of controls wit...
Governance, Risk and Compliance Analyst
- Roxbury Crossing, MA (10 miles from Lexington, MA)
- 8 days ago
- Roxbury Crossing, MA (10 miles from Lexington, MA)
- 8 days ago
Governance, Risk and Compliance Analyst About the Opportunity This job description is intended to describe the general nature and level of work being performed by people assigned to this...
- Boston, MA (10 miles from Lexington, MA)
- 8 days ago
- Boston, MA (10 miles from Lexington, MA)
- 8 days ago
About Us** Here at Baylor Scott & White Health we promote the well-being of all individuals, families, and communities. Baylor Scott and White is the largest not-for-profit healthcare system in...
Senior Regulatory Affairs Specialist
- Marlborough, MA (18 miles from Lexington, MA)
- 10 days ago
- Marlborough, MA (18 miles from Lexington, 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...
Business Intelligence and Compliance Analyst- REMOTE
- Boston, MA (10 miles from Lexington, MA)
- 10 days ago
- Boston, MA (10 miles from Lexington, MA)
- 10 days ago
Job Seekers can review the Job Applicant Privacy Policy by clicking here ( ). Job Description : Summary The Business Intelligence, Analytics & Reporting Analyst will gather, analyze, and...
Remote WorkGovernance, Risk and Compliance Analyst Northeastern University
- Boston, MA (10 miles from Lexington, MA)
- 11 days ago
- Boston, MA (10 miles from Lexington, MA)
- 11 days ago
Governance, Risk and Compliance Analyst About the Opportunity This job description is intended to describe the general nature and level of work being performed by people assigned to this...
- Andover, MA (13 miles from Lexington, MA)
- 15 days ago
- Andover, MA (13 miles from Lexington, MA)
- 15 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...
REMOTE Loan Servicing Compliance Analyst, I
- Boston, MA (10 miles from Lexington, MA)
- 16 days ago
- Boston, MA (10 miles from Lexington, MA)
- 16 days ago
Come join our amazing team and work remote from home!** The Loan Servicing Compliance Analyst I will be responsible for the provisioning documentation for various audit and exam documentation....
Remote WorkRemote Retirement Plan Compliance Analyst
- Boston, MA (10 miles from Lexington, MA)
- 19 days ago
- Boston, MA (10 miles from Lexington, MA)
- 19 days ago
FuturePlan is the nation's largest third-party administrator (TPA) of retirement plans, partnering with advisors in all 50 states. FuturePlan delivers the best of both worlds: high-touch...
Remote WorkDemographic Data for Lexington, MA
Moving to Lexington, MA? Find some basic demographic data about Lexington, MA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Lexington, MA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Lexington, 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
- Consulting
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- 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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