Regulatory Affairs Specialist Jobs in Milford, 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.
Regulatory & Compliance Specialist - Open Rank
- University of Massachusetts Medical School
- Worcester, MA (16 miles from Milford, MA)
- 2 days ago
- Worcester, MA (16 miles from Milford, MA)
- 2 days ago
audits of research activities and investigate complaints Assess the educational needs of the research community, recommend training opportunities, and conduct individual and/or group training sessions...
In Person- UnitedHealth Group Inc.
- Worcester, MA (16 miles from Milford, MA)
- 6 days ago
- Worcester, MA (16 miles from Milford, MA)
- 6 days ago
audits of physician billing and medical records documentation to ensure: Correct Coding (CPT, ICD-10, HCPCS, Modifiers), Accurate Data Entry, Accurate Charge Preparation/Processing, Compliance with...
Remote- Dentsply Sirona
- Waltham, MA (21 miles from Milford, MA)
- 8 days ago
- Waltham, MA (21 miles from Milford, 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
- Mansfield, MA (18 miles from Milford, MA)
- 11 days ago
- Mansfield, MA (18 miles from Milford, 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- Medtronic Inc.
- Mansfield, MA (18 miles from Milford, MA)
- 12 days ago
- Mansfield, MA (18 miles from Milford, MA)
- 12 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 PersonSenior IT Security, Risk & Compliance Analyst
- Ardelyx
- Waltham, MA (21 miles from Milford, MA)
- 15 days ago
- Waltham, MA (21 miles from Milford, 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 (21 miles from Milford, MA)
- 15 days ago
- Waltham, MA (21 miles from Milford, 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...
HybridSenior Compliance Analyst - Sun Life U.S. Compliance
- Sun Life
- Wellesley Hills, MA (16 miles from Milford, MA)
- 19 days ago
- Wellesley Hills, MA (16 miles from Milford, MA)
- 19 days ago
Support for regulatory examinations, Internal Audits or other regulatory matters may be required as appropriate....
HybridSenior Global Trade Compliance Analyst
- Mathworks, Inc.
- Natick, MA (12 miles from Milford, MA)
- 26 days ago
- Natick, MA (12 miles from Milford, MA)
- 26 days ago
Senior Global Trade Compliance Analyst JavaScript Not Enabled Your browser settings are preventing you from taking full advantage of the MathWorks Careers application. You can enable JavaScript...
In PersonGlobal Trade Compliance Analyst
- Mathworks, Inc.
- Natick, MA (12 miles from Milford, MA)
- 27 days ago
- Natick, MA (12 miles from Milford, MA)
- 27 days ago
Global Trade Compliance Analyst JavaScript Not Enabled Your browser settings are preventing you from taking full advantage of the MathWorks Careers application. You can enable JavaScript within...
In PersonSenior Regulatory Affairs Specialist
- Boston Scientific
- Marlborough, MA (13 miles from Milford, MA)
- 30+ days ago
- Marlborough, MA (13 miles from Milford, 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....
HybridJob Description We're looking for a meticulous and analytical Regulatory Affairs Specialist to join our team in Milford, United States....
In PersonSenior Regulatory Affairs Specialist
- Wolters Kluwer
- Waltham, MA (21 miles from Milford, MA)
- 60+ days ago
- Waltham, MA (21 miles from Milford, 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 Milford, MA
Moving to Milford, MA? Find some basic demographic data about Milford, MA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Milford, MA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Milford, 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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