Regulatory Affairs Specialist Jobs in Tyngsboro, 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.
- MKS Inc.
- Andover, MA (13 miles from Tyngsboro, MA)
- 1 day ago
- Andover, MA (13 miles from Tyngsboro, MA)
- 1 day ago
MKS Instruments is seeking a Sr. Global Trade Management Analyst with deep U.S. import and export expertise. The ideal candidate will manage HTS and ECCN classification, qualify goods under FTAs...
In Person- Dentsply Sirona
- Waltham, MA (20 miles from Tyngsboro, MA)
- 8 days ago
- Waltham, MA (20 miles from Tyngsboro, MA)
- 8 days ago
**Summary:** We are seeking an experienced and highly motivated Regulatory Affairs Specialist who will be a contributing member of a cross-functional team in support of regulatory market access activities...
In PersonSenior Regulatory Affairs Specialist
- Smith & Nephew
- Andover, MA (13 miles from Tyngsboro, MA)
- 11 days ago
- Andover, MA (13 miles from Tyngsboro, MA)
- 11 days ago
(k) submissions and EU MDR filings Strong understanding of global regulatory requirements and medical device development processes Excellent written and verbal communication skills, including technical...
HybridSenior IT Security, Risk & Compliance Analyst
- Ardelyx
- Waltham, MA (20 miles from Tyngsboro, MA)
- 15 days ago
- Waltham, MA (20 miles from Tyngsboro, MA)
- 15 days ago
Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a...
Hybrid- natgridProd
- Waltham, MA (20 miles from Tyngsboro, MA)
- 15 days ago
- Waltham, MA (20 miles from Tyngsboro, MA)
- 15 days ago
About us Every day we deliver safe and secure energy to homes, communities, and businesses. We are there when people need us the most. We connect people to the energy they need for the lives they...
Hybrid- MACOM
- Lowell, MA (6 miles from Tyngsboro, MA)
- 16 days ago
- Lowell, MA (6 miles from Tyngsboro, MA)
- 16 days ago
MACOM designs and manufactures semiconductor products for Data Center, Telecommunication and Industrial and Defense applications. Headquartered in Lowell, Massachusetts, MACOM has design centers...
In Person- ZOLL Medical Corporation*
- Chelmsford, MA (6 miles from Tyngsboro, MA)
- 25 days ago
- Chelmsford, MA (6 miles from Tyngsboro, MA)
- 25 days ago
*Author and prepare submittals of IDEs, 510(k), PMAs, Technical Files or Design Dossiers, and other pertinent regional device applications....
RemoteInformation Security Compliance Analyst
- Digital Prospectors
- Cambridge, MA (24 miles from Tyngsboro, MA)
- 30+ days ago
- Cambridge, MA (24 miles from Tyngsboro, MA)
- 30+ days ago
Job Requirements Cambridge, MA Secret Polygraph not specified Mid Level Career (5+ yrs experience) Salary not specified Join Premium to unlock estimated salaries Job Description Position: Senior...
In PersonSenior Regulatory Affairs Specialist
- Boston Scientific
- Marlborough, MA (22 miles from Tyngsboro, MA)
- 30+ days ago
- Marlborough, MA (22 miles from Tyngsboro, MA)
- 30+ days ago
We are looking to hire an enthusiastic individual for a Senior Regulatory Affairs Specialist position (hybrid work mode) supporting our rapidly growing active implantable device portfolio....
HybridJunior InfoSec Compliance Analyst
- Digital Prospectors
- Cambridge, MA (24 miles from Tyngsboro, MA)
- 30+ days ago
- Cambridge, MA (24 miles from Tyngsboro, MA)
- 30+ days ago
Junior InfoSec Compliance Analyst Digital Prospectors United States, Massachusetts, Cambridge Apr 27, 2026 Position: Junior Information Security Analyst Location:Boston, MA (Hybrid/Must be Local)...
In Person- H P Hood LLC
- Wilmington, MA (14 miles from Tyngsboro, MA)
- 30+ days ago
- Wilmington, MA (14 miles from Tyngsboro, MA)
- 30+ days ago
Are you a self-driven person looking to advance your career as a high-impact player on a team? If so, we have an exciting challenge for you and your future! Our culture is built on value...
In PersonSenior Security Compliance Analyst
- NetBrain
- Burlington, MA (15 miles from Tyngsboro, MA)
- 45+ days ago
- Burlington, MA (15 miles from Tyngsboro, MA)
- 45+ days ago
Senior Security Compliance Analyst What We Need We are seeking a security and compliance leader to build and operationalize a scalable security program for our SaaS environment. This role will...
In PersonSenior Regulatory Affairs Specialist
- Philips
- Cambridge, MA (24 miles from Tyngsboro, MA)
- 45+ days ago
- Cambridge, MA (24 miles from Tyngsboro, MA)
- 45+ days ago
Job Title Senior Regulatory Affairs Specialist Job Description Senior Regulatory Affairs Specialist, Ultrasound The Senior Regulatory Affairs Specialist for Ultrasound collaborates with regulatory teams...
In PersonSenior Regulatory Affairs Specialist
- Wolters Kluwer
- Waltham, MA (20 miles from Tyngsboro, MA)
- 60+ days ago
- Waltham, MA (20 miles from Tyngsboro, MA)
- 60+ days ago
About the Role: As the Senior Regulatory Affairs Specialist, you will serve as a regulatory lead expert supporting the expansion of our Software as a Medical Device (SaMD) portfolio across global markets...
In PersonDemographic Data for Tyngsboro, MA
Moving to Tyngsboro, MA? Find some basic demographic data about Tyngsboro, MA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Tyngsboro, MA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Tyngsboro, 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
- Filing
- Financial Services
- Reimbursement
- Annuities
- Quality Management Systems
- 21 CFR 820
- Internal Audits
- Corrective Actions & Preventive Actions
- ISO 13485
- Validation
- Medical Device Sales
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Continuous Improvement
- Product Development
- Microsoft SharePoint
- Technical Writing
- Analytical Skills
- Risk Management
- Engineering
- Strategy Development
- Auditing
- Military Background
- Written Communication
- Investigation
- Process Improvement
- Documentation
- Implementation
- Verbal Communication
- Reporting
- Policy Development
- Data Analysis
- Education Experience
- Collaboration
- Microsoft PowerPoint
- Bachelor's Degree
- Regulations
- Microsoft Word
- Microsoft Excel
- Research Skills
- Microsoft Office
- Project Management
- Problem Solving
- Staff Supervision
- Scheduling
- Time Management
- Leadership
- Communication Skills
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