Manager of Regulatory Affairs Jobs in Massachusetts
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.
You have extensive experience/knowledge of global medical device regulations, requirements, and standards (ISO 13485, ISO 14971, 21 CFR 820, etc.)...
Pioneering Medicines: Senior Director, Regulatory Affairs
- Cambridge, MA
- 4 days ago
- Cambridge, MA
- 4 days ago
What if... We could harness the power of Flagship's scientific platforms and create novel treatment options that benefit more patients, sooner? Pioneering Medicines, an initiative of Flagship...
Visterra is seeking a Regulatory Affairs professional experienced in biologics development to lead our Regulatory Team's strategy and oversee the teams activities from IND-enabling studies and...
Position Summary: The Regulatory Affairs Director (RAD), Global Regulatory Strategy will be responsible for the development and implementation of global regulatory strategies for all assigned...
With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and...
Associate Director/Director of Regulatory Affairs Location Boston Discipline: Regulatory Affairs Job type: Permanent Salary: DOE Contact name: Josh Swistak Contact email: ... Contact phone: +......
regulations; ICH guidelines; Leading cross-functional product development teams....
At Corner Therapeutics, Inc, our mission is to transform the standard of care, ushering in a new era of robust, rapid, patient-friendly and low-cost immunotherapies - even for the most difficult...
Seaport Therapeutics is a clinical-stage biopharmaceutical company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven...
Fulcrum Therapeutics, Inc. ("Fulcrum") [NASDAQ: FULC] is a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined...
Associate Director Regulatory Affairs Job details Salary $175K - $195K Location Boston, Massachusetts Employment type Permanent Discipline Life Sciences Job description Position: Associate...
Senior Director Regulatory Affairs, Sports Medicine & ENT
- Andover, MA
- 24 days ago
- Andover, MA
- 24 days ago
In-depth knowledge of FDA regulations, EU MDR, ISO 13485, and other international regulatory standards....
Program Manager, Regulatory Affairs - Remote Job Details Olympus Corporation of the Americas
- Westborough, MA
- 25 days ago
- Westborough, MA
- 25 days ago
Job Description Assist the Manager, Regulatory Affairs in obtaining approval to market Olympus medical devices in the markets served by Olympus....
regulations, particularly 21 CFR 1271 and 21 CFR 312....
#ChangeMakers Ready to make an impact? We develop, manufacture, and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth...
Demographic Data for Massachusetts
Moving to Massachusetts? Find some basic demographic data about Massachusetts 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 Massachusetts
Required or preferred licenses and certifications for Manager of Regulatory Affairs positions.
Highest Education Level
Manager of Regulatory Affairss in Massachusetts offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Manager of Regulatory Affairs position
- Clinical Research
- Biochemistry
- Biology
- Immunology
- Medical Writing
- Scientific Writing
- Drug Development
- Clinical Trials
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Masters In Education
- Gene Therapy
- ICH GCP
- Quality Systems
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- GxP
- Microbiology
- Medical Device Sales
- Document Management
- Product Launch
- FDA Regulations
- Research and Development
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Auditing
- Implementation
- Military Background
- Written Communication
- Mentoring
- Interpersonal Skills
- Employee Development
- Collaboration
- Documentation
- Reporting
- Coaching
- Filing
- Regulations
- Policy Development
- Bachelor's Degree
- Microsoft PowerPoint
- Microsoft Office
- Project Management
- Problem Solving
- Microsoft Excel
- Sales
- 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 »