Director of Regulatory Affairs Jobs in Bedford, 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.
Associate Director, Regulatory Affairs CMC
- Cambridge, MA (11 miles from Bedford, MA)
- 1 day ago
- Cambridge, MA (11 miles from Bedford, MA)
- 1 day 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 (14 miles from Bedford, MA)
- 3 days ago
- Boston, MA (14 miles from Bedford, MA)
- 3 days ago
This position reports to the Director, Regulatory Affairs and will be ideally located in Boston, MA, USA. We will consider other jurisdictions for exceptional candidates....
Senior Manager, Regulatory Affairs
- Waltham, MA (7 miles from Bedford, MA)
- 4 days ago
- Waltham, MA (7 miles from Bedford, MA)
- 4 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 (11 miles from Bedford, MA)
- 5 days ago
- Cambridge, MA (11 miles from Bedford, MA)
- 5 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 (11 miles from Bedford, MA)
- 6 days ago
- Cambridge, MA (11 miles from Bedford, MA)
- 6 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 for...
Director, Regulatory Affairs, LED
- Waltham, MA (7 miles from Bedford, MA)
- 6 days ago
- Waltham, MA (7 miles from Bedford, MA)
- 6 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 (7 miles from Bedford, MA)
- 7 days ago
- Waltham, MA (7 miles from Bedford, MA)
- 7 days ago
Company Description Position Summary: The Senior Manager, Regulatory Affairs provides regulatory support for oncology products in early- and late-stage development. In this role, the Senior...
Associate Regulatory Affairs Director
- Boston, MA (14 miles from Bedford, MA)
- 8 days ago
- Boston, MA (14 miles from Bedford, MA)
- 8 days ago
Associate Regulatory Affairs Director Introduction to role The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management capabilities...
Executive Director of Regulatory Affairs
- Cambridge, MA (11 miles from Bedford, MA)
- 9 days ago
- Cambridge, MA (11 miles from Bedford, MA)
- 9 days ago
A fast-growing oncology business seeks an Executive Director of Regulatory Affairs to lead a remote US hematology team....
Senior Director, Regulatory Affairs
- Waltham, MA (7 miles from Bedford, MA)
- 9 days ago
- Waltham, MA (7 miles from Bedford, MA)
- 9 days ago
The Senior Director of Regulatory Affairs will report to the Chief Medical Officer and manage a small Regulatory Affairs team supporting Visterra's biologic programs....
Regulatory Affairs Director, Global Regulatory Strategy
- Boston, MA (14 miles from Bedford, MA)
- 11 days ago
- Boston, MA (14 miles from Bedford, MA)
- 11 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...
R & D Sr. Regulatory Affairs Manager
- Boston, MA (14 miles from Bedford, MA)
- 13 days ago
- Boston, MA (14 miles from Bedford, MA)
- 13 days ago
R & D Sr. Regulatory Affairs Manager LOCATION Boston, MA TYPE Direct Hire ID FL... POSTED Apr 4, 2025 Description SUMMARY The Senior Manager of Regulatory Affairs will lead the regulatory...
Executive Director, Regulatory Affairs Strategy
- Cambridge, MA (11 miles from Bedford, MA)
- 13 days ago
- Cambridge, MA (11 miles from Bedford, MA)
- 13 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...
- Burlington, MA (3 miles from Bedford, MA)
- 14 days ago
- Burlington, MA (3 miles from Bedford, MA)
- 14 days ago
Experience with prescription drug advertising regulations and promotional review committee's Working knowledge of FDA regulations and understanding of FDA structure and function....
Senior Director, Regulatory Affairs
- Waltham, MA (7 miles from Bedford, MA)
- 15 days ago
- Waltham, MA (7 miles from Bedford, MA)
- 15 days ago
Role Summary: The Senior Director, Regulatory Affairs helps drive forward our regulatory strategy and operational activities related to Dyne's muscle disease programs....
Demographic Data for Bedford, MA
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Salary for Director of Regulatory Affairs Jobs in Bedford, MA
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
Highest Education Level
Director of Regulatory Affairss in Bedford, MA 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
- Bioinformatics
- Biology
- Immunology
- Medical Writing
- Drug Development
- Clinical Trials
- Biomedical Engineering
- Drug Discovery
- Biotechnology
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- Internal Audits
- Quality Management Systems
- Quality Systems
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- Change Control
- Good Clinical Practice
- Microbiology
- Medical Device Sales
- FDA Regulations
- Document Management
- Research and Development
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Affirmative Action
- Risk Management
- Strategy Development
- Quality Assurance
- Process Improvement
- Implementation
- Auditing
- Written Communication
- Verbal Communication
- Strategic Planning
- Documentation
- Mentoring
- Collaboration
- Reporting
- Education Experience
- Interpersonal Skills
- Coaching
- Bachelor's Degree
- Regulations
- Policy Development
- Project Management
- Problem Solving
- Microsoft Office
- Microsoft Excel
- Teamwork
- Staff Supervision
- Organization
- Research Skills
- Leadership
- Communication Skills
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