Manager of Regulatory Affairs Jobs in Burlington, MA
A Manager of Regulatory Affairs in the quality control industry plays a pivotal role in ensuring that the company's products meet all necessary regulatory standards. Their key responsibilities include developing and implementing regulatory strategies, monitoring changes to regulatory guidelines, and ensuring the organization's compliance with these changes. They also engage in the preparation, review, and submission of regulatory documents to regulatory agencies. To effectively execute these responsibilities, they liaise with various stakeholders within and outside the organization, such as product developers, project managers, and regulatory bodies.
Important skills and certifications for a Manager of Regulatory Affairs include strong organizational and project management skills, excellent written and verbal communication skills, as well as a keen eye for detail. Analytical thinking and problem-solving skills are also crucial in this role. Additionally, they should possess relevant certifications such as the Regulatory Affairs Certification (RAC), which is recognized worldwide as the leading credential for regulatory professionals in the healthcare product sector. Before becoming a Manager of Regulatory Affairs, a person may have roles such as a Regulatory Affairs Specialist, Quality Control Analyst, or a Quality Assurance Associate. These roles would provide the necessary exposure and experience in quality control and regulatory affairs needed for the managerial position.
Senior Manager, Regulatory Affairs
- Salem, MA (15 miles from Burlington, MA)
- 19 hours ago
- Salem, MA (15 miles from Burlington, MA)
- 19 hours ago
Job Overview We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager, Regulatory Affairs....
Sr Director, Regulatory Affairs Advertising, Promotion & Labeling
- Cambridge, MA (9 miles from Burlington, MA)
- 2 days ago
- Cambridge, MA (9 miles from Burlington, MA)
- 2 days ago
Maintain current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters and policies issues affecting the pharmaceutical/biologics industry....
Remote Work- Cambridge, MA (9 miles from Burlington, MA)
- 3 days ago
- Cambridge, MA (9 miles from Burlington, MA)
- 3 days ago
Director, Regulatory Affairs Cambridge, MA | On-site An innovative biotech company based in Cambridge is seeking a Director of Regulatory Affairs to serve as the organization's first regulatory...
Director, Regulatory Affairs Strategy
- Boston, MA (12 miles from Burlington, MA)
- 5 days ago
- Boston, MA (12 miles from Burlington, MA)
- 5 days ago
Location: REMOTE Salary: $190,000.00 USD Annually - $215,000.00 USD Annually Description: Our client is currently seeking a Director, Regulatory Affairs Strategy who will be responsible for...
Quality Systems & Regulatory Affairs Manager
- Boston, MA (12 miles from Burlington, MA)
- 6 days ago
- Boston, MA (12 miles from Burlington, MA)
- 6 days ago
management and regulatory strategy within WHOOP Support development and maintenance of WHOOPs FDA-compliant QMS, ensuring adherence to 21 CFR 820 and ISO 13485:2016 Coordinate and lead internal audits...
- Wellesley Hills, MA (14 miles from Burlington, MA)
- 6 days ago
- Wellesley Hills, MA (14 miles from Burlington, MA)
- 6 days ago
Manager, Regulatory Affairs based at our corporate headquarters in Wellesley, MA....
Global Publishing Manager, Regulatory Affairs
- Cambridge, MA (9 miles from Burlington, MA)
- 9 days ago
- Cambridge, MA (9 miles from Burlington, MA)
- 9 days ago
The Role The Regulatory Operations Global Publishing Manager is responsible for overseeing the planning, creation, and submission of regulatory submissions. In collaboration with the Regulatory...
Remote WorkAssociate Director, Regulatory Affairs CMC
- Cambridge, MA (9 miles from Burlington, MA)
- 11 days ago
- Cambridge, MA (9 miles from Burlington, MA)
- 11 days ago
Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular...
Senior Manager, Regulatory Affairs (Clinical)
- Boston, MA (12 miles from Burlington, MA)
- 13 days ago
- Boston, MA (12 miles from Burlington, MA)
- 13 days ago
About the Role: We are seeking a Senior Manager, Regulatory Affairs to join our team....
Senior Manager, Regulatory Affairs
- Waltham, MA (8 miles from Burlington, MA)
- 14 days ago
- Waltham, MA (8 miles from Burlington, MA)
- 14 days ago
The Senior Manager, Regulatory Operations will report to the Executive Director of Regulatory Operations and will be responsible for submission management across the development pipeline and...
Senior Manager, Regulatory Affairs
- Cambridge, MA (9 miles from Burlington, MA)
- 15 days ago
- Cambridge, MA (9 miles from Burlington, MA)
- 15 days ago
RAC certification recommended Proficiency with Microsoft Office Applications; Word, Excel, Outlook, Adobe, and regulatory/quality systems. What Now?...
Director, Regulatory Affairs Operations
- Cambridge, MA (9 miles from Burlington, MA)
- 17 days ago
- Cambridge, MA (9 miles from Burlington, MA)
- 17 days ago
Director of Regulatory Affairs Operations, Ultrasound** The Director of Regulatory Affairs Operations for the Ultrasound business will be responsible for leading a global Regulatory Affairs team...
Director, Regulatory Affairs, LED
- Waltham, MA (8 miles from Burlington, MA)
- 17 days ago
- Waltham, MA (8 miles from Burlington, MA)
- 17 days ago
system and regulatory product compliance requirements; e.g 21 CFR 820, ISO 13485/9001, QMSR, EU MDR, ISO 14971, UL, CSA, NSF, NMPA, Health Canada We provide competitive salary, an annual incentive...
Senior Manager, Regulatory Affairs
- Waltham, MA (8 miles from Burlington, MA)
- 17 days ago
- Waltham, MA (8 miles from Burlington, MA)
- 17 days ago
Company Description Position Summary: The Senior Manager, Regulatory Affairs provides regulatory support for oncology products in early- and late-stage development....
Senior Director, Regulatory Affairs
- Waltham, MA (8 miles from Burlington, MA)
- 19 days ago
- Waltham, MA (8 miles from Burlington, MA)
- 19 days ago
Senior Director, Regulatory Affairs Regulatory - Waltham, Massachusetts Visterra is seeking a Regulatory Affairs professional experienced in biologics development to lead our Regulatory Team's...
Demographic Data for Burlington, MA
Moving to Burlington, MA? Find some basic demographic data about Burlington, MA below.
Manager of Regulatory Affairs Online Courses and Training Opportunities
Title Synonyms
Users interested in this job title also searched for the following job title
Salary for Manager of Regulatory Affairs Jobs in Burlington, MA
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in Burlington, MA offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Regulatory Affairs position
- Medical Terminology
- Clinical Research
- Biology
- Immunology
- Oncology
- Assay Development
- Neurology
- Medical Writing
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Gene Therapy
- Biomarkers
- Internal Audits
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Military Background
- Implementation
- Investigation
- Written Communication
- Verbal Communication
- Documentation
- Mentoring
- Collaboration
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Coaching
- Regulations
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
Other Career Titles
Here are some other career titles that require similar skills
Manager of Regulatory Affairs Related Career Advice Articles
Top Skills and Quality Control Training You Need to Get Promoted
Ready to take your quality control career to the next level? Seek out quality control training for these highly desired skills for quality control jobs.
Read article »
Quality Assurance vs. Quality Control: What’s the Difference?
Deciding on a career in QA vs. QC can be tough if you don’t know which is which. Find out the difference between quality control and quality assurance.
Read article »
5 Quality Control Career Possibilities
As a specialty that spans numerous industries, QC offers many career paths. Which option is right for you? Read on to learn about the many possibilities available to QC professionals and find the opportunity that fits you best.
Read article »