Regulatory Affairs Specialist Jobs in Hopkinton, 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.
- Computech Corporation
- Cumberland, RI (19 miles from Hopkinton, MA)
- 2 hours ago
- Computech Corporation
- Cumberland, RI (19 miles from Hopkinton, MA)
- 2 hours ago
Job Title: Analyst I - Compliance Job Location:200 Highland Corporate Drive, Cumberland, RI, USA, 02864, Monday - Friday (Hybrid Wednesday in office) RI preferred, AZ accepted Schedule Hours:...
Sr Regulatory Affairs Specialist--Remote
- Marlborough, MA (8 miles from Hopkinton, MA)
- 7 days ago
- Marlborough, MA (8 miles from Hopkinton, MA)
- 7 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 II
- Bedford, MA (22 miles from Hopkinton, MA)
- 10 days ago
- Bedford, MA (22 miles from Hopkinton, MA)
- 10 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 (18 miles from Hopkinton, MA)
- 10 days ago
- Waltham, MA (18 miles from Hopkinton, MA)
- 10 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 (21 miles from Hopkinton, MA)
- 10 days ago
- Canton, MA (21 miles from Hopkinton, MA)
- 10 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 (17 miles from Hopkinton, MA)
- 11 days ago
- Norwood, MA (17 miles from Hopkinton, MA)
- 11 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...
Sr Regulatory Affairs Specialist (Medical Device)
- Framingham, MA (8 miles from Hopkinton, MA)
- 12 days ago
- Framingham, MA (8 miles from Hopkinton, MA)
- 12 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 (22 miles from Hopkinton, MA)
- 13 days ago
- Bedford, MA (22 miles from Hopkinton, MA)
- 13 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,...
Coding/Billing Compliance Analyst
- Somerville, MA (24 miles from Hopkinton, MA)
- 16 days ago
- Somerville, MA (24 miles from Hopkinton, MA)
- 16 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...
- Cambridge, MA (22 miles from Hopkinton, MA)
- 20 days ago
- Cambridge, MA (22 miles from Hopkinton, MA)
- 20 days ago
Compliance Analyst Job details Posted 27 May 2025 Location Cambridge, MA Job type Permanent Reference 965817 Job description Job Title: Compliance Analyst Location : Cambridge MA Contract : (6...
- Cambridge, MA (22 miles from Hopkinton, MA)
- 22 days ago
- Cambridge, MA (22 miles from Hopkinton, MA)
- 22 days ago
Compliance Analyst Location: Cambridge, MA (Hybrid) Join our client's dynamic team as a Compliance Analyst in the Global Ethics & Compliance Department. This role is perfect for someone who is...
Sr. Regulatory Compliance Specialist
- Marlborough, MA (8 miles from Hopkinton, MA)
- 24 days ago
- Marlborough, MA (8 miles from Hopkinton, MA)
- 24 days ago
Knowledge Deep understanding of global medical device regulatory frameworks and Quality Systems Management requirements....
- Cambridge, MA (22 miles from Hopkinton, MA)
- 30+ days ago
- Cambridge, MA (22 miles from Hopkinton, MA)
- 30+ days ago
USA - Compliance Analyst#25-58860 Cambridge, MA All On-site Job Description Top skills needed: Compliance monitoring Minimum 5 years pharma/medical device company Cambridge, MA OBJECTIVES/PURPOSE...
- Needham, MA (15 miles from Hopkinton, MA)
- 30+ days ago
- Needham, MA (15 miles from Hopkinton, MA)
- 30+ days ago
The Analyst is primarily responsible for assisting with data validation management and quality assurance, consistent with the requirements of the Home Mortgage Disclosure Act (HMDA) and Community...
Info Security Compliance Analyst
- Chestnut Hill, MA (20 miles from Hopkinton, MA)
- 30+ days ago
- Chestnut Hill, MA (20 miles from Hopkinton, MA)
- 30+ days ago
Boston College Introduction Founded in 1863, Boston College is a Jesuit, Catholic university located six miles from downtown Boston with an enrollment of 9,484 full-time undergraduates and 5,250...
Demographic Data for Hopkinton, MA
Moving to Hopkinton, MA? Find some basic demographic data about Hopkinton, MA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Hopkinton, MA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Hopkinton, MA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- 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
- Interpersonal Skills
- 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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