Regulatory Affairs Specialist Jobs in Newton, 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 (20 miles from Newton, MA)
- 1 day ago
- Andover, MA (20 miles from Newton, 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 PersonDavis-Bacon Act Compliance Analyst (Cont
- Beacon Hill Solutions Group, LLC
- Boston, MA (6 miles from Newton, MA)
- 1 day ago
- Boston, MA (6 miles from Newton, MA)
- 1 day ago
Beacon Hill was founded to set a new standard in search, career placement and flexible staffing. Overview Beacon Hill Legal is looking for a Davis-Bacon Act Compliance Analyst to support federal...
In PersonSenior Regulatory Compliance Specialist Medical Device
- Oracle
- Boston, MA (6 miles from Newton, MA)
- 4 days ago
- Boston, MA (6 miles from Newton, MA)
- 4 days ago
quality management activities....
In PersonRegulatory Compliance Analyst 4
- WEX Inc.
- Boston, MA (6 miles from Newton, MA)
- 5 days ago
- Boston, MA (6 miles from Newton, MA)
- 5 days ago
About the Team / Role Reporting to the Director, Corporate Compliance, the Regulatory Compliance Analyst 4 will assist with the coordination and integration of Corporate Compliance activities to...
In PersonSecure Configuration Management Compliance Analyst , AVP Quincy, MA, USA
- State Street Corporation
- Quincy, MA (11 miles from Newton, MA)
- 7 days ago
- Quincy, MA (11 miles from Newton, MA)
- 7 days ago
Secure Configuration Management Compliance Analyst, AVP Role: Secure Configuration Management Compliance Analyst Who we are looking for We are looking for a driven and analytical Secure...
In Person- Dentsply Sirona
- Waltham, MA (4 miles from Newton, MA)
- 8 days ago
- Waltham, MA (4 miles from Newton, 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 (20 miles from Newton, MA)
- 11 days ago
- Andover, MA (20 miles from Newton, 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...
Hybrid- Kforce
- Boston, MA (6 miles from Newton, MA)
- 12 days ago
- Boston, MA (6 miles from Newton, MA)
- 12 days ago
Kforce has a client in Boston, MA that is seeking a Audit/Compliance Analyst. Responsibilities: Provide technical accounting guidance on complex or non-routine transactions Research and interpret...
In Person- Medtronic Inc.
- Mansfield, MA (23 miles from Newton, MA)
- 13 days ago
- Mansfield, MA (23 miles from Newton, MA)
- 13 days ago
A Day in the Life The Principal Regulatory Affairs Specialist will play a key role in launching new products and sustaining the Wound Management product portfolio....
In Person- The Boston Beer Company, Inc.
- Boston, MA (6 miles from Newton, MA)
- 14 days ago
- Boston, MA (6 miles from Newton, MA)
- 14 days ago
We are currently hiring a FT Associate Compliance Analyst hybrid in Boston, MA. The Associate Compliance Analyst provides support to obtain commercial approval of alcoholic beverages worldwide...
HybridPrincipal Regulatory Affairs Specialist
- Medtronic Inc.
- Danvers, MA (19 miles from Newton, MA)
- 14 days ago
- Danvers, MA (19 miles from Newton, MA)
- 14 days ago
The Principal Regulatory Affairs Specialist will provide strategic leadership for regulatory affairs in support of new product development and introduction within Medtronic's Structural Heart Operating...
In PersonSenior IT Security, Risk & Compliance Analyst
- Ardelyx
- Waltham, MA (4 miles from Newton, MA)
- 15 days ago
- Waltham, MA (4 miles from Newton, 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 (4 miles from Newton, MA)
- 15 days ago
- Waltham, MA (4 miles from Newton, 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 (21 miles from Newton, MA)
- 16 days ago
- Lowell, MA (21 miles from Newton, 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 PersonSenior Compliance Analyst - Sun Life U.S. Compliance
- Sun Life
- Wellesley Hills, MA (5 miles from Newton, MA)
- 19 days ago
- Wellesley Hills, MA (5 miles from Newton, MA)
- 19 days ago
Support for regulatory examinations, Internal Audits or other regulatory matters may be required as appropriate....
HybridDemographic Data for Newton, MA
Moving to Newton, MA? Find some basic demographic data about Newton, MA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Newton, MA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Newton, 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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