Regulatory Affairs Specialist Jobs in Westborough, 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 (9 miles from Westborough, MA)
- 23 hours ago
- Framingham, MA (9 miles from Westborough, MA)
- 23 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 Westborough, MA)
- 1 day ago
- Sudbury, MA (12 miles from Westborough, 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 (9 miles from Westborough, MA)
- 5 days ago
- Framingham, MA (9 miles from Westborough, 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 (20 miles from Westborough, MA)
- 14 days ago
- Waltham, MA (20 miles from Westborough, MA)
- 14 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 (9 miles from Westborough, MA)
- 15 days ago
- Worcester, MA (9 miles from Westborough, MA)
- 15 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 (9 miles from Westborough, MA)
- 15 days ago
- Framingham, MA (9 miles from Westborough, 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 (20 miles from Westborough, MA)
- 18 days ago
- Waltham, MA (20 miles from Westborough, 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...
- Lexington, MA (24 miles from Westborough, MA)
- 26 days ago
- Lexington, MA (24 miles from Westborough, 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 (9 miles from Westborough, MA)
- 27 days ago
- Framingham, MA (9 miles from Westborough, MA)
- 27 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 Specialist, Regulatory Affairs - Remote
- Westborough, MA
- 60+ days ago
- Westborough, 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...
Sr Regulatory Affairs Specialist
- Marlborough, MA (6 miles from Westborough, MA)
- 30+ days ago
- Marlborough, MA (6 miles from Westborough, MA)
- 30+ days ago
JOB SUMMARY – To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Responsible for determining the path to market for new and modifications...
Demographic Data for Westborough, MA
Moving to Westborough, MA? Find some basic demographic data about Westborough, MA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Westborough, MA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Westborough, 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
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- FDA Regulations
- Document Management
- Microsoft Visio
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Data Analysis
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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