Regulatory Affairs Specialist Jobs in Hudson, NH
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 (14 miles from Hudson, NH)
- 1 day ago
- Andover, MA (14 miles from Hudson, NH)
- 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 PersonSenior Regulatory Affairs Specialist
- Smith & Nephew
- Andover, MA (14 miles from Hudson, NH)
- 10 days ago
- Andover, MA (14 miles from Hudson, NH)
- 10 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- ZOLL Medical Corporation*
- Chelmsford, MA (12 miles from Hudson, NH)
- 24 days ago
- Chelmsford, MA (12 miles from Hudson, NH)
- 24 days ago
*Author and prepare submittals of IDEs, 510(k), PMAs, Technical Files or Design Dossiers, and other pertinent regional device applications....
Remote- H P Hood LLC
- Wilmington, MA (18 miles from Hudson, NH)
- 30+ days ago
- Wilmington, MA (18 miles from Hudson, NH)
- 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 (20 miles from Hudson, NH)
- 45+ days ago
- Burlington, MA (20 miles from Hudson, NH)
- 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 PersonDemographic Data for Hudson, NH
Moving to Hudson, NH? Find some basic demographic data about Hudson, NH below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Hudson, NH
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Hudson, NH 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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