Regulatory Affairs Specialist Jobs in Somerville, 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.
IT Security Regulatory & Compliance - Associate
- Quincy, MA (10 miles from Somerville, MA)
- 4 hours ago
- Quincy, MA (10 miles from Somerville, MA)
- 4 hours ago
IT Security Regulatory & Compliance - AssociateCountry: United States of America Your Journey Starts Here: Santander is a global leader and innovator in the financial services industry. We believe...
Principal Regulatory Affairs Specialist
- Salem, MA (13 miles from Somerville, MA)
- 13 hours ago
- Salem, MA (13 miles from Somerville, MA)
- 13 hours ago
Job Summary: Cardinal Health is seeking a Principal Regulatory Affairs Specialist to support the Medical Solutions Regulatory Affairs team....
Senior Staff IT Risk & Compliance Analyst - Remote available
- Framingham, MA (17 miles from Somerville, MA)
- 13 hours ago
- Framingham, MA (17 miles from Somerville, MA)
- 13 hours ago
TJX Companies At TJX Companies, every day brings new opportunities for growth, exploration, and achievement. You'll be part of our vibrant team that embraces diversity, fosters collaboration, and...
Remote WorkSenior Regulatory Affairs Specialist / Regulatory Affairs Manager (994)
- Sudbury, MA (16 miles from Somerville, MA)
- 1 day ago
- Sudbury, MA (16 miles from Somerville, MA)
- 1 day ago
Senior Regulatory Affairs Specialist / Regulatory Affairs Manager Job Details Job Location Littleton, Ma Corporate Office - Littleton, MA Position Type Full Time Job Category QA - Quality Control Job...
Regulatory Operations Specialist (Contract)
- Boston, MA (2 miles from Somerville, MA)
- 2 days ago
- Boston, MA (2 miles from Somerville, MA)
- 2 days ago
Company Overview Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a...
Lease Compliance Analyst - Office of Real Estate Management
- Boston, MA (2 miles from Somerville, MA)
- 2 days ago
- Boston, MA (2 miles from Somerville, MA)
- 2 days ago
Lease Compliance Analyst - Office of Real Estate Management (250001FA) Job Description Lease Compliance Analyst - Office of Real Estate Management - (250001FA) Description DCAMM'S Mission The...
- Boston, MA (2 miles from Somerville, MA)
- 2 days ago
- Boston, MA (2 miles from Somerville, MA)
- 2 days ago
. + Own audit readiness and guide teams through federal and state exams, internal audits, and testing processes with confidence and clarity. + Turn insights into action by analyzing results, delivering...
Remote WorkExport Sr. Trade Compliance Analyst
- Billerica, MA (14 miles from Somerville, MA)
- 2 days ago
- Billerica, MA (14 miles from Somerville, MA)
- 2 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...
- Boston, MA (2 miles from Somerville, MA)
- 3 days ago
- Boston, MA (2 miles from Somerville, MA)
- 3 days ago
Guided by our company Purpose of "Inspiring well-being for our colleagues, consumers, and communities," we are committed to building a best-in-class Law Department. We drive a high-performance...
Medicare Compliance Analyst II or III
- Salem, MA (13 miles from Somerville, MA)
- 4 days ago
- Salem, MA (13 miles from Somerville, MA)
- 4 days ago
Job Listing ID: 4258095 Job Title: Medicare Compliance Analyst II or III Application Deadline: 05/23/2025Job Location: Salem Date Posted: 04/23/2025Hours Worked Per Week: 32 Shift: Day Shift...
Remote WorkSenior Staff IT Risk & Compliance Analyst
- Framingham, MA (17 miles from Somerville, MA)
- 5 days ago
- Framingham, MA (17 miles from Somerville, MA)
- 5 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...
Principal Regulatory Affairs Specialist Pathai
- Boston, MA (2 miles from Somerville, MA)
- 5 days ago
- Boston, MA (2 miles from Somerville, MA)
- 5 days ago
Affairs Specialist to play a key role in supporting regulatory strategies and ensuring the success of our diagnostic products in the global market.This role involves preparing global product submissions...
- Boston, MA (2 miles from Somerville, MA)
- 8 days ago
- Boston, MA (2 miles from Somerville, MA)
- 8 days ago
We have an exciting opportunity as a Senior Compliance Analyst who will join and be supported by a large global asset management compliance organization which is part of the Ameriprise Financial...
- Boston, MA (2 miles from Somerville, MA)
- 10 days ago
- Boston, MA (2 miles from Somerville, MA)
- 10 days ago
Otsuka Pharmaceuticals - Trade Compliance Analyst** **Position Summary:** + Provide technical and analytical support for customs and trade compliance matters at the North Americasite/division(s)...
Senior Security Trust & Compliance Analyst
- Boston, MA (2 miles from Somerville, MA)
- 10 days ago
- Boston, MA (2 miles from Somerville, MA)
- 10 days ago
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...
Demographic Data for Somerville, MA
Moving to Somerville, MA? Find some basic demographic data about Somerville, MA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Somerville, MA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Somerville, 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
- Institutional Review Board
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Root Cause Analysis
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Implementation
- Military Background
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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