Director of Regulatory Affairs Jobs in Massachusetts
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.
Job Title: Director, Regulatory Affairs Department: Regulatory Affairs and Compliance Manager/Supervisor: Sr....
Senior Manager, Regulatory Affairs CMC (Hybrid Onsite)
- Waltham, MA
- 5 days ago
- Waltham, MA
- 5 days ago
Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive...
Position Summary: We are seeking a strategic, hands-on Associate Director OR Director, Regulatory Affairs to lead regulatory project teams and submission activities across assigned development programs...
About the Role >>> Director, Regulatory Labeling As the Director, Regulatory Labeling, reporting to the Vice President, Regulatory Affairs and Quality Assurance you will lead the development of...
This position reports to the Director, Regulatory Affairs, Operations and will be in Boston, MA, USA. We will consider other jurisdictions for exceptional candidates....
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
- 21 days ago
- Cambridge, MA
- 21 days ago
Position Summary: Pioneering Medicines is seeking a curious, driven Senior Director, Regulatory Affairs with pharma/biotech experience to support Clinical Development for one or more early development...
The Senior Director of Regulatory Affairs will report to the Chief Medical Officer and manage a small Regulatory Affairs team supporting Visterras biologic programs....
Regulatory Affairs Director, Global Regulatory Strategy
- Boston, MA
- 22 days ago
- Boston, MA
- 22 days ago
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...
Reporting Structure Reports To: Senior Director, Regulatory Affairs, Strategy and Lifecycle Management Direct Reports: N/A Areas Managed: Regulatory Affairs Overview Manage RRD Regulatory Affairs for...
Associate Director/Director of Regulatory Affairs Location Boston Discipline: Regulatory Affairs Job type: Permanent Salary: DOE Contact name: Josh Swistak Contact email: ... Contact phone: +......
(f/ka BeiGene) seeks Director, Regulatory Affairs in Cambridge, MA, USA: Job Duties: Provides high level regulatory strategic and operational direction and mentorship on projects including, but not...
The Role Reporting to the Chief Medical Officer, the Director of Regulatory Affairs will be responsible for developing and implementing global strategies to secure and maintain market approval for product...
Senior Director Regulatory Affairs, Sports Medicine & ENT
- Andover, MA
- 30+ days ago
- Andover, MA
- 30+ 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
- 30+ days ago
- Westborough, MA
- 30+ days ago
Working Location: NATIONWIDE Workplace Flexibility: Field For more than 100 years, Olympus has focused on making people's lives healthier, safer and more fulfilling. Every day, we live by our...
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Highest Education Level
Director of Regulatory Affairss in Massachusetts offer the following education backgroundQualifications / Skill Sets
The following top skills are often required or desired to land a Director of Regulatory Affairs position
- Clinical Research
- Biochemistry
- Biology
- Immunology
- Drug Development
- Clinical Trials
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Masters In Education
- Gene Therapy
- Internal Audits
- Quality Systems
- Supplier Auditing
- Quality Management Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- GxP
- Medical Device Sales
- Product Launch
- Document Management
- Research and Development
- FDA Regulations
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Quality Assurance
- Auditing
- Military Background
- Implementation
- Written Communication
- Education Experience
- Mentoring
- Documentation
- Employee Development
- Reporting
- Coaching
- Collaboration
- Interpersonal Skills
- Filing
- Bachelor's Degree
- Policy Development
- Regulations
- Project Management
- Problem Solving
- Microsoft Excel
- Teamwork
- Research Skills
- Time Management
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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