Regulatory Affairs Specialist Jobs in Plympton, 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.
Environmental Compliance Analyst
- Avon, MA (16 miles from Plympton, MA)
- 2 days ago
- Avon, MA (16 miles from Plympton, MA)
- 2 days ago
Atlas is a nationwide leader in civil engineering, materials testing and geotechnical consulting services for environmental, industrial and infrastructure construction projects. Headquartered in...
Principal Regulatory Affairs Specialist
- Plymouth, MA (11 miles from Plympton, MA)
- 3 days ago
- Plymouth, MA (11 miles from Plympton, MA)
- 3 days ago
You have expertise in understanding, interpretation, and application of FDA 21 CFR 820 Quality System Regulation, EU MDR Regulation 2017/745, ISO 13485, and other relevant standards and regulations....
- Mansfield, MA (21 miles from Plympton, MA)
- 5 days ago
- Mansfield, MA (21 miles from Plympton, MA)
- 5 days ago
Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections....
Principal Regulatory Affairs Specialist
- Mansfield, MA (21 miles from Plympton, MA)
- 6 days ago
- Mansfield, MA (21 miles from Plympton, MA)
- 6 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....
Senior Regulatory Affairs Specialist
- Canton, MA (21 miles from Plympton, MA)
- 24 days ago
- Canton, MA (21 miles from Plympton, MA)
- 24 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 (24 miles from Plympton, MA)
- 26 days ago
- Norwood, MA (24 miles from Plympton, MA)
- 26 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...
Demographic Data for Plympton, MA
Moving to Plympton, MA? Find some basic demographic data about Plympton, MA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Plympton, MA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Plympton, MA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Consulting
- Environmental Compliance
- Geotechnical Engineering
- Civil Engineering
- Internal Audits
- 21 CFR 820
- ISO 13485
- Medical Device Sales
- Business Processes
- Microsoft Visio
- FDA Regulations
- Standard Operating Procedures
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Quality Assurance
- Process Improvement
- Auditing
- Analytical Skills
- Implementation
- High School Diploma
- Investigation
- Written Communication
- Verbal Communication
- Data Analysis
- Collaboration
- Documentation
- Reporting
- Bachelor's Degree
- Data Entry
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Multitasking
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Customer Service
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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