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.
Senior Staff IT Risk & Compliance Analyst - Remote available
- Framingham, MA (8 miles from Hopkinton, MA)
- 16 hours ago
- Framingham, MA (8 miles from Hopkinton, MA)
- 16 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 (12 miles from Hopkinton, MA)
- 1 day ago
- Sudbury, MA (12 miles from Hopkinton, 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...
Senior Staff IT Risk & Compliance Analyst
- Framingham, MA (8 miles from Hopkinton, MA)
- 5 days ago
- Framingham, MA (8 miles from Hopkinton, 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...
Senior Auditing & Compliance Analyst
- Waltham, MA (18 miles from Hopkinton, MA)
- 13 days ago
- Waltham, MA (18 miles from Hopkinton, MA)
- 13 days ago
The Compliance Analyst, Health & Regulatory Compliance Group will support all members of the Health Regulatory & Compliance Group with managing multiple activities and projects required for...
Sr Regulatory Compliance Specialist
- Worcester, MA (14 miles from Hopkinton, MA)
- 14 days ago
- Worcester, MA (14 miles from Hopkinton, MA)
- 14 days ago
Rise Baking Company was founded by bakery experts passionate about providing our customers with high quality products and providing a positive, collaborative place to work for our people. We are a...
Senior IT Risk & Compliance Analyst - Remote Available
- Framingham, MA (8 miles from Hopkinton, MA)
- 15 days ago
- Framingham, MA (8 miles from Hopkinton, MA)
- 15 days ago
TJX Companies Chez TJX Companies, chaque jour apporte de nouvelles occasions de croissance, de decouverte et d'accomplissement. Vous ferez partie d'une equipe dynamique qui prone la diversite,...
Remote WorkPrincipal Regulatory Affairs Specialist
- Waltham, MA (18 miles from Hopkinton, MA)
- 18 days ago
- Waltham, MA (18 miles from Hopkinton, MA)
- 18 days ago
Systems standards and clinical investigations Solid understanding and knowledge of product development process, clinical development, manufacturing, and change control Demonstrated experience authoring...
- Smithfield, RI (22 miles from Hopkinton, MA)
- 19 days ago
- Smithfield, RI (22 miles from Hopkinton, MA)
- 19 days ago
The Role As a Registration and Licensing Compliance Analyst you will work as part of a team that is responsible for supporting Fidelity associates through the registration process. In this role...
Senior Regulatory Affairs Specialist - ACM
- Mansfield, MA (21 miles from Hopkinton, MA)
- 22 days ago
- Mansfield, MA (21 miles from Hopkinton, MA)
- 22 days ago
A Day in the Life We are seeking a Senior Regulatory Affairs Specialist to join our team within Medtronic Acute Care and Monitoring (ACM)....
Lending Compliance Analyst Massachusetts Institute of Technology (MIT)
- Cambridge, MA (22 miles from Hopkinton, MA)
- 25 days ago
- Cambridge, MA (22 miles from Hopkinton, MA)
- 25 days ago
LENDING COMPLIANCE ANALYST, Credit Union, will support, implement, and monitor the end-to-end internal compliance audit monitoring program for the Consumer and Lending departments to ensure...
- Lexington, MA (22 miles from Hopkinton, MA)
- 26 days ago
- Lexington, MA (22 miles from Hopkinton, MA)
- 26 days ago
LENDING COMPLIANCE ANALYST, Credit Union, will support, implement, and monitor the end-to-end internal compliance audit monitoring program for the Consumer and Lending departments to ensure...
Senior IT Risk & Compliance Analyst
- Framingham, MA (8 miles from Hopkinton, MA)
- 26 days ago
- Framingham, MA (8 miles from Hopkinton, MA)
- 26 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...
Coding/Billing Compliance Analyst
- Somerville, MA (24 miles from Hopkinton, MA)
- 28 days ago
- Somerville, MA (24 miles from Hopkinton, MA)
- 28 days ago
Site: Mass General Brigham Incorporated At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our mission-from doctors, nurses, business people and tech...
Senior Specialist, Regulatory Affairs - Remote
- Westborough, MA (4 miles from Hopkinton, MA)
- 60+ days ago
- Westborough, MA (4 miles from Hopkinton, MA)
- 60+ days ago
Working Location: NATIONWIDE Workplace Flexibility: Field For more than 100 years, Olympus has focused on making peoples lives healthier, safer and more fulfilling. Every day, we live by our...
Principal Regulatory Affairs Specialist
- Cambridge, MA (22 miles from Hopkinton, MA)
- 30+ days ago
- Cambridge, MA (22 miles from Hopkinton, MA)
- 30+ days ago
Philips Principal Regulatory Affairs Specialist in Cambridge , Massachusetts Principal Regulatory Affairs Specialist (Pittsburgh, PA or Cambridge, MA) The Principal Regulatory Affairs Specialist will...
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
- 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
- Military Background
- Implementation
- 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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