Regulatory Affairs Specialist Jobs in Hingham, 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.
- Plymouth, MA (24 miles from Hingham, MA)
- 2 days ago
- Plymouth, MA (24 miles from Hingham, MA)
- 2 days ago
Support the implementation and maintenance of Rockland Trusts IT Change Management and IT Asset Management (ITAM) Standards, helping ensure compliance with internal policies and external audit or...
Information Security Compliance Analyst
- Lakeville, MA (23 miles from Hingham, MA)
- 3 days ago
- Lakeville, MA (23 miles from Hingham, MA)
- 3 days ago
Ocean Spray is hiring for a(n) Information Security Compliance Analyst! Were a team of farmers, thinkers, creators, and doers. Whatever your title, whatever your role it always comes back to this:...
Remote WorkRegulatory Affairs Specialist - Post Market
- Boston, MA (15 miles from Hingham, MA)
- 7 days ago
- Boston, MA (15 miles from Hingham, MA)
- 7 days ago
Regulatory Affairs Specialist - Post Market - req1434** **OVERVIEW** Reporting to the Director Regulatory Affairs, the Regulatory Affairs Specialist is responsible for complaint handling, coordination...
Remote WorkSenior Data & Compliance Analyst
- Boston, MA (15 miles from Hingham, MA)
- 8 days ago
- Boston, MA (15 miles from Hingham, MA)
- 8 days ago
Senior Data & Compliance Analyst (2093)** + Title:Senior Data & Compliance Analyst + Group Company: Mitsubishi Chemical America + Location:Remote Group Company: + Mitsubishi Chemical America...
Portfolio Compliance Analyst - CLO/SMA products
- Boston, MA (15 miles from Hingham, MA)
- 9 days ago
- Boston, MA (15 miles from Hingham, MA)
- 9 days ago
As a leading financial services and healthcare technology company based on revenue, SS&C is headquartered in Windsor, Connecticut, and has 27,000+ employees in 35 countries. Some 20,000 financial...
Regulatory Operations Specialist
- Waltham, MA (24 miles from Hingham, MA)
- 9 days ago
- Waltham, MA (24 miles from Hingham, MA)
- 9 days ago
Awareness of the FDA regulations Experience with Microsoft Office Suite (Word, Excel, PowerPoint, Office), Word Templates and Adobe Professional....
Senior Regulatory Affairs Specialist
- Canton, MA (12 miles from Hingham, MA)
- 9 days ago
- Canton, MA (12 miles from Hingham, MA)
- 9 days ago
About Us We are a leading regenerative medicine company in the advanced and acute wound care space and are always looking for exceptional talent. Join a company where you will have an opportunity...
- Norwood, MA (15 miles from Hingham, MA)
- 11 days ago
- Norwood, MA (15 miles from Hingham, MA)
- 11 days ago
The Senior Compliance Analyst will actively participate in the Compliance Departments mission to prevent, detect, and manage consumer compliance risk. The Senior Compliance Analyst will monitor...
- Boston, MA (15 miles from Hingham, MA)
- 11 days ago
- Boston, MA (15 miles from Hingham, MA)
- 11 days ago
Who we are Zus is a shared health data platform designed to accelerate healthcare data interoperability by providing easy-to-use patient data via API, embedded components, and direct EHR...
Coding/Billing Compliance Analyst
- Somerville, MA (17 miles from Hingham, MA)
- 16 days ago
- Somerville, MA (17 miles from Hingham, MA)
- 16 days ago
Site: Mass General Brigham Incorporated Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to...
- Cambridge, MA (19 miles from Hingham, MA)
- 19 days ago
- Cambridge, MA (19 miles from Hingham, MA)
- 19 days ago
Compliance Analyst Job details Posted 27 May 2025 Location Cambridge, MA Job type Permanent Reference 965817 Job description Job Title: Compliance Analyst Location : Cambridge MA Contract : (6...
- Cambridge, MA (19 miles from Hingham, MA)
- 21 days ago
- Cambridge, MA (19 miles from Hingham, MA)
- 21 days ago
Compliance Analyst Location: Cambridge, MA (Hybrid) Join our client's dynamic team as a Compliance Analyst in the Global Ethics & Compliance Department. This role is perfect for someone who is...
Regulatory Affairs Coordinator II
- Boston, MA (15 miles from Hingham, MA)
- 25 days ago
- Boston, MA (15 miles from Hingham, MA)
- 25 days ago
Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to...
Remote Work- Boston, MA (15 miles from Hingham, MA)
- 25 days ago
- Boston, MA (15 miles from Hingham, MA)
- 25 days ago
Compliance Analyst San Antonio | Boston About Victory Capital: Victory Capital is a diversified global asset management firm and employs a next-generation business strategy that combines boutique...
- Cambridge, MA (19 miles from Hingham, MA)
- 30+ days ago
- Cambridge, MA (19 miles from Hingham, MA)
- 30+ days ago
USA - Compliance Analyst#25-58860 Cambridge, MA All On-site Job Description Top skills needed: Compliance monitoring Minimum 5 years pharma/medical device company Cambridge, MA OBJECTIVES/PURPOSE...
Demographic Data for Hingham, MA
Moving to Hingham, MA? Find some basic demographic data about Hingham, MA below.
Regulatory Affairs Specialist Online Courses and Training Opportunities
Salary for Regulatory Affairs Specialist Jobs in Hingham, MA
Required or preferred licenses and certifications for Regulatory Affairs Specialist positions.
Highest Education Level
Regulatory Affairs Specialists in Hingham, MA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Regulatory Affairs Specialist position
- Internal Audits
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Corrective Actions & Preventive Actions
- Medical Device Sales
- Business Processes
- FDA Regulations
- Resolution
- Standard Operating Procedures
- Product Development
- Affirmative Action
- Engineering
- Risk Management
- Military Background
- Analytical Skills
- Implementation
- Auditing
- Investigation
- Verbal Communication
- Writing Skills
- Data Analysis
- Written Communication
- Collaboration
- Documentation
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Microsoft Office
- Project Management
- Problem Solving
- Sales
- Microsoft Excel
- Microsoft Word
- Time Management
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Computer Skills
- Leadership
- Communication Skills
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