Regulatory Affairs Specialist Jobs in Boston, 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.
- Burlington, MA (12 miles from Boston, MA)
- 4 hours ago
- Burlington, MA (12 miles from Boston, MA)
- 4 hours ago
We are currently seeking a Regulatory Affairs Specialist to join our team....
Regulatory Affairs Specialist, Biologics
- Tewksbury, MA (19 miles from Boston, MA)
- 3 days ago
- Tewksbury, MA (19 miles from Boston, MA)
- 3 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 (24 miles from Boston, MA)
- 6 days ago
- Marlborough, MA (24 miles from Boston, MA)
- 6 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 WorkRegulatory Affairs Specialist - Post Market - req1434** **OVERVIEW** Reporting to the Director Regulatory Affairs, the Regulatory Affairs Specialist is responsible for complaint handling, coordination...
Remote WorkSenior Data & Compliance Analyst (2093)** + Title:Senior Data & Compliance Analyst + Group Company: Mitsubishi Chemical America + Location:Remote Group Company: + Mitsubishi Chemical America...
As a leading financial services and healthcare technology company based on revenue, SS&C is headquartered in Windsor, Connecticut, and has 27,000+ employees in 35 countries. Some 20,000 financial...
Regulatory Affairs Specialist II
- Bedford, MA (14 miles from Boston, MA)
- 9 days ago
- Bedford, MA (14 miles from Boston, MA)
- 9 days ago
Regulatory Affairs Specialist II 3.1 3.1 out of 5 stars 180 Hartwell Road, Bedford, MA 01730 Overview: Position Summary: Responsible for domestic and/or international registration and renewal activities...
Regulatory Operations Specialist
- Waltham, MA (10 miles from Boston, MA)
- 9 days ago
- Waltham, MA (10 miles from Boston, MA)
- 9 days ago
Awareness of the FDA regulations Experience with Microsoft Office Suite (Word, Excel, PowerPoint, Office), Word Templates and Adobe Professional....
Senior Regulatory Affairs Specialist
- Canton, MA (12 miles from Boston, MA)
- 9 days ago
- Canton, MA (12 miles from Boston, MA)
- 9 days ago
About Us We are a leading regenerative medicine company in the advanced and acute wound care space and are always looking for exceptional talent. Join a company where you will have an opportunity...
- Norwood, MA (13 miles from Boston, MA)
- 10 days ago
- Norwood, MA (13 miles from Boston, MA)
- 10 days ago
The Senior Compliance Analyst will actively participate in the Compliance Departments mission to prevent, detect, and manage consumer compliance risk. The Senior Compliance Analyst will monitor...
Who we are Zus is a shared health data platform designed to accelerate healthcare data interoperability by providing easy-to-use patient data via API, embedded components, and direct EHR...
Sr Regulatory Affairs Specialist (Medical Device)
- Framingham, MA (19 miles from Boston, MA)
- 11 days ago
- Framingham, MA (19 miles from Boston, MA)
- 11 days ago
Our client is currently seeking a Senior Regulatory Affairs Specialist. This is a permanent, direct hire, fully on-site position. Medical Device experience required....
Senior Regulatory Affairs Specialist
- Bedford, MA (14 miles from Boston, MA)
- 12 days ago
- Bedford, MA (14 miles from Boston, MA)
- 12 days ago
Overview Position Summary: Responsible to lead domestic and/or international registration and renewal activities for Werfen-labeled products. Related duties include participation on design teams,...
Regulatory Affairs Specialist (Austin, TX)
- Andover, MA (20 miles from Boston, MA)
- 15 days ago
- Andover, MA (20 miles from Boston, MA)
- 15 days ago
Knowledge of regulatory compliance requirements (e.g. 21 CFR 820, ISO13485:2016, EU MDR, GMP etc)....
Coding/Billing Compliance Analyst
- Somerville, MA (2 miles from Boston, MA)
- 15 days ago
- Somerville, MA (2 miles from Boston, MA)
- 15 days ago
Site: Mass General Brigham Incorporated Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to...
Demographic Data for Boston, MA
Moving to Boston, MA? Find some basic demographic data about Boston, MA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Boston, MA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Boston, MA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Medical Device Sales
- Business Processes
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Product Development
- Affirmative Action
- Engineering
- Risk Management
- Military Background
- Analytical Skills
- Implementation
- Auditing
- Investigation
- Verbal Communication
- Writing Skills
- Data Analysis
- Written Communication
- Collaboration
- Documentation
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Sales
- Microsoft Excel
- Microsoft Word
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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