Regulatory Affairs Specialist Jobs in Newburyport, 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.
Principal Regulatory Compliance Specialist
- Danvers, MA (16 miles from Newburyport, MA)
- 19 hours ago
- Danvers, MA (16 miles from Newburyport, MA)
- 19 hours ago
Provide internal audit inputs/updates to Quality System Management Reviews to allow meaningful review of their tasks. Participate in JJRC audits as requested....
- Andover, MA (18 miles from Newburyport, MA)
- 15 days ago
- Andover, MA (18 miles from Newburyport, MA)
- 15 days ago
Who We Are Enel North America is a proven renewables leader delivering clean, flexible and sustainable energy solutions. As part of the Enel Group, we develop, build, own and operate renewable...
Senior Risk & Compliance Analyst
- Salem, MA (20 miles from Newburyport, MA)
- 23 days ago
- Salem, MA (20 miles from Newburyport, MA)
- 23 days ago
Job Listing ID: 4305843 Job Title: Senior Risk & Compliance Analyst Application Deadline: Open Until FilledJob Location: Salem Date Posted: 07/05/2025Hours Worked Per Week: Not Provided Shift: Not...
Regulatory Affairs Specialist (Austin, TX)
- Andover, MA (18 miles from Newburyport, MA)
- 60+ days ago
- Andover, MA (18 miles from Newburyport, MA)
- 60+ days ago
Knowledge of regulatory compliance requirements (e.g. 21 CFR 820, ISO13485:2016, EU MDR, GMP etc)....
Principal Regulatory Affairs Specialist
- Wilmington, MA (22 miles from Newburyport, MA)
- 60+ days ago
- Wilmington, MA (22 miles from Newburyport, MA)
- 60+ days ago
13485 standard and 21 CFR 820 regulation....
Demographic Data for Newburyport, MA
Moving to Newburyport, MA? Find some basic demographic data about Newburyport, MA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Newburyport, MA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Newburyport, 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
- Consulting
- Internal Control
- Management Reporting
- Operations Analysis
- Internal Audits
- 21 CFR 820
- ISO 13485
- Corrective Actions & Preventive Actions
- Business Processes
- Medical Device Sales
- FDA Regulations
- Resolution
- Microsoft SharePoint
- Product Development
- Engineering
- Risk Management
- Process Improvement
- Auditing
- Military Background
- Implementation
- Analytical Skills
- Investigation
- Written Communication
- Education Experience
- Verbal Communication
- Documentation
- Data Analysis
- Reporting
- Collaboration
- Interpersonal Skills
- Filing
- Microsoft PowerPoint
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Research Skills
- Sales
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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