Regulatory Affairs Specialist Jobs in Norwell, 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.
- Boston, MA (18 miles from Norwell, MA)
- 1 day ago
- Boston, MA (18 miles from Norwell, MA)
- 1 day ago
Otsuka Pharmaceuticals - Trade Compliance Analyst** **Position Summary:** + Provide technical and analytical support for customs and trade compliance matters at the North Americasite/division(s)...
Senior Security Trust & Compliance Analyst
- Boston, MA (18 miles from Norwell, MA)
- 1 day ago
- Boston, MA (18 miles from Norwell, MA)
- 1 day ago
At Klaviyo, we value the unique backgrounds, experiences and perspectives each Klaviyo (we call ourselves Klaviyos) brings to our workplace each and every day. We believe everyone deserves a fair...
Principal Regulatory Affairs Specialist, Pharmaceutical Products (Hybrid)
- Boston, MA (18 miles from Norwell, MA)
- 3 days ago
- Boston, MA (18 miles from Norwell, MA)
- 3 days ago
We are currently seeking a **Principal Regulatory Affairs Specialist,** ( **Pharmaceutical Products** ) to join our **Medical** Division. This is a Hybrid role based in Cary, Illinois....
Operational Risk and Compliance Analyst
- Boston, MA (18 miles from Norwell, MA)
- 4 days ago
- Boston, MA (18 miles from Norwell, MA)
- 4 days ago
Who we are looking for State Streets Global Credit Finance (GCF) division has established an Operational Risk and Compliance function which adds value to the business in the identification,...
- Boston, MA (18 miles from Norwell, MA)
- 7 days ago
- Boston, MA (18 miles from Norwell, MA)
- 7 days ago
Your Future Evolves Here** Evolent partners with health plans and providers to achieve better outcomes for people with most complex and costly health conditions. Working across specialties and...
Senior Regulatory Compliance Analyst
- Boston, MA (18 miles from Norwell, MA)
- 9 days ago
- Boston, MA (18 miles from Norwell, MA)
- 9 days ago
Why This Role Stands Out: Impactful Work: Contribute significantly to the firms compliance infrastructure, particularly concerning US registered investment companies. Your expertise will support...
External Audit & Quality Assurance Compliance Analyst
- Boston, MA (18 miles from Norwell, MA)
- 9 days ago
- Boston, MA (18 miles from Norwell, MA)
- 9 days ago
POSITION SUMMARY: The External Audit & Quality Assurance Compliance Analyst supports the organization's compliance program by coordinating external audits, ensuring adherence to regulatory...
Senior Regulatory Affairs Specialist - ACM
- Mansfield, MA (22 miles from Norwell, MA)
- 13 days ago
- Mansfield, MA (22 miles from Norwell, MA)
- 13 days ago
A Day in the Life We are seeking a Senior Regulatory Affairs Specialist to join our team within Medtronic Acute Care and Monitoring (ACM)....
Lending Compliance Analyst Massachusetts Institute of Technology (MIT)
- Cambridge, MA (22 miles from Norwell, MA)
- 16 days ago
- Cambridge, MA (22 miles from Norwell, MA)
- 16 days ago
LENDING COMPLIANCE ANALYST, Credit Union, will support, implement, and monitor the end-to-end internal compliance audit monitoring program for the Consumer and Lending departments to ensure...
Compliance Analyst-Advisory Services
- Braintree, MA (10 miles from Norwell, MA)
- 19 days ago
- Braintree, MA (10 miles from Norwell, MA)
- 19 days ago
Together we fight for everyones opportunity for a better financial future. We will do this together with customers, partners and colleagues. We will fight for others, not against: We will stand up...
Coding/Billing Compliance Analyst
- Somerville, MA (21 miles from Norwell, MA)
- 19 days ago
- Somerville, MA (21 miles from Norwell, MA)
- 19 days ago
Site: Mass General Brigham Incorporated At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our mission-from doctors, nurses, business people and tech...
- Boston, MA (18 miles from Norwell, MA)
- 24 days ago
- Boston, MA (18 miles from Norwell, MA)
- 24 days ago
Vaco Boston has partnered with our client to hire a Trade Compliance Analyst to join their team! Candidates must have experience with HTS US and classification of products/parts. Where: Fully...
Remote Work- Boston, MA (18 miles from Norwell, MA)
- 25 days ago
- Boston, MA (18 miles from Norwell, MA)
- 25 days ago
Vaco Boston has partnered with our client who is looking to add a Global Compliance Analyst to their team. Must have manufacturing and international trade experience Responsibilities: research...
Principal Regulatory Affairs Specialist
- Cambridge, MA (22 miles from Norwell, MA)
- 27 days ago
- Cambridge, MA (22 miles from Norwell, MA)
- 27 days ago
Philips Principal Regulatory Affairs Specialist in Cambridge , Massachusetts Principal Regulatory Affairs Specialist (Pittsburgh, PA or Cambridge, MA) The Principal Regulatory Affairs Specialist will...
Senior Information Security Compliance Analyst
- Boston, MA (18 miles from Norwell, MA)
- 28 days ago
- Boston, MA (18 miles from Norwell, MA)
- 28 days ago
Senior Information Security Compliance Analyst Senior Information Security Compliance Analyst Boston, MA Hybrid Contract $50/hr - $65/hr Our client is looking for a Senior Information Security...
Demographic Data for Norwell, MA
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Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Norwell, MA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Norwell, 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
- Medicaid
- Flexibility
- Call Center Experience
- Medicare
- Internal Control
- Management Reporting
- Fraud Investigation
- Reimbursement
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Medical Device Sales
- FDA Regulations
- Business Processes
- Document Management
- Microsoft Visio
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Implementation
- Auditing
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Collaboration
- Reporting
- Data Analysis
- Education Experience
- Interpersonal Skills
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Sales
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Time Management
- Staff Supervision
- Organization
- Research Skills
- Scheduling
- Leadership
- Communication Skills
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