Regulatory Affairs Specialist Jobs in Whitinsville, 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 Risk & Compliance Analyst
- Providence, RI (24 miles from Whitinsville, MA)
- 6 hours ago
- Providence, RI (24 miles from Whitinsville, MA)
- 6 hours ago
Company :** Highmark Health **Job Description :** **JOB SUMMARY** This job works collaboratively riskacross Highmark Health clinical areas to support clinical quality auditing, The Senior Risk...
- Needham, MA (23 miles from Whitinsville, MA)
- 1 day ago
- Needham, MA (23 miles from Whitinsville, MA)
- 1 day ago
This is a hybrid position based in Needham. Onsite presence of 1-2 days/week is expected. All candidates must live within commuting distance to office. Why Work With Us? At Candel, our people...
Regulatory Affairs Specialist - ACM
- Mansfield, MA (23 miles from Whitinsville, MA)
- 2 days ago
- Mansfield, MA (23 miles from Whitinsville, MA)
- 2 days ago
A Day in the Life The Senior Regulatory Affairs Specialist (Sr....
Public Sector Compliance Analyst
- Providence, RI (24 miles from Whitinsville, MA)
- 5 days ago
- Providence, RI (24 miles from Whitinsville, MA)
- 5 days ago
Be the spark that brightens days and ignite your career with TTECs award-winning employment experience. As a Public Sector Compliance Analyst working remote in the United States, youll be a part...
Remote WorkPrincipal Regulatory Affairs Specialist
- Mansfield, MA (23 miles from Whitinsville, MA)
- 10 days ago
- Mansfield, MA (23 miles from Whitinsville, MA)
- 10 days ago
**A Day in the Life** As a **Principal Regulatory Affairs Specialist** at Medtronic, you will play a critical role in shaping the global regulatory strategy for innovative medical technologies....
Remote IT Quality Assurance and Compliance, Analyst
- Providence, RI (24 miles from Whitinsville, MA)
- 10 days ago
- Providence, RI (24 miles from Whitinsville, MA)
- 10 days ago
Come join our amazing team and work remote from home!** **What youll do:** Responsible for the timely and accurate response to audit and compliance requests for the enterprise while also ensuring...
Remote Work- Norwood, MA (24 miles from Whitinsville, MA)
- 29 days ago
- Norwood, MA (24 miles from Whitinsville, MA)
- 29 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 (17 miles from Whitinsville, MA)
- 30+ days ago
- Framingham, MA (17 miles from Whitinsville, MA)
- 30+ 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....
Sr. Regulatory Compliance Specialist
- Marlborough, MA (16 miles from Whitinsville, MA)
- 30+ days ago
- Marlborough, MA (16 miles from Whitinsville, MA)
- 30+ days ago
Knowledge Deep understanding of global medical device regulatory frameworks and Quality Systems Management requirements....
Demographic Data for Whitinsville, MA
Moving to Whitinsville, MA? Find some basic demographic data about Whitinsville, MA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Whitinsville, MA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Whitinsville, 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
- Vendor Management
- Internal Control
- Reimbursement
- Operations Analysis
- Internal Audits
- 21 CFR 820
- Corrective Actions & Preventive Actions
- ISO 13485
- Medical Device Sales
- Business Processes
- Microsoft Visio
- FDA Regulations
- Standard Operating Procedures
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Implementation
- Military Background
- Analytical Skills
- High School Diploma
- Investigation
- Written Communication
- Verbal Communication
- Data Analysis
- Education Experience
- Collaboration
- Documentation
- Reporting
- Filing
- Regulations
- Bachelor's Degree
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Sales
- Microsoft Excel
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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