Director of Regulatory Affairs Jobs in Waltham, 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.
Director, Regulatory Affairs, Specialty
- Cambridge, MA (6 miles from Waltham, MA)
- moments ago
- Cambridge, MA (6 miles from Waltham, MA)
- moments ago
Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Collegeville TSA, USA - Maryland - Rockville Posted Date: Apr 29 2025 Job Purpose Ensure the development of appropriate...
Senior Manager, Regulatory Affairs
- Salem, MA (19 miles from Waltham, MA)
- 22 hours ago
- Salem, MA (19 miles from Waltham, MA)
- 22 hours ago
Job Listing ID: 4259842 Job Title: Senior Manager, Regulatory Affairs Application Deadline: Open Until FilledJob Location: Salem Date Posted: 04/25/2025Hours Worked Per Week: Not Provided Shift:...
Sr Director, Regulatory Affairs Advertising, Promotion & Labeling
- Cambridge, MA (6 miles from Waltham, MA)
- 2 days ago
- Cambridge, MA (6 miles from Waltham, MA)
- 2 days ago
The Senior Director Regulatory Affairs Advertising, Promotion & Labeling (Sr. Dir....
Remote Work- Cambridge, MA (6 miles from Waltham, MA)
- 3 days ago
- Cambridge, MA (6 miles from Waltham, 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 hire...
Director, Regulatory Affairs Strategy
- Boston, MA (10 miles from Waltham, MA)
- 5 days ago
- Boston, MA (10 miles from Waltham, 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 contributing...
Quality Systems & Regulatory Affairs Manager
- Boston, MA (10 miles from Waltham, MA)
- 6 days ago
- Boston, MA (10 miles from Waltham, 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...
Sr. Manager, Regulatory Affairs
- Wellesley Hills, MA (6 miles from Waltham, MA)
- 7 days ago
- Wellesley Hills, MA (6 miles from Waltham, MA)
- 7 days ago
Sr. Manager, Regulatory Affairs About Climb Bio: Climb Bio is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. Our product candidates...
Global Publishing Manager, Regulatory Affairs
- Cambridge, MA (6 miles from Waltham, MA)
- 10 days ago
- Cambridge, MA (6 miles from Waltham, MA)
- 10 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 (6 miles from Waltham, MA)
- 12 days ago
- Cambridge, MA (6 miles from Waltham, MA)
- 12 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 (10 miles from Waltham, MA)
- 13 days ago
- Boston, MA (10 miles from Waltham, MA)
- 13 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....
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 (6 miles from Waltham, MA)
- 15 days ago
- Cambridge, MA (6 miles from Waltham, 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 (6 miles from Waltham, MA)
- 17 days ago
- Cambridge, MA (6 miles from Waltham, 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 for...
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...
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...
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Salary for Director of Regulatory Affairs Jobs in Waltham, MA
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
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Director of Regulatory Affairss in Waltham, 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
- 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
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