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.
ESSENTIAL JOB FUNCTIONS: The Assoc Dir/Director, Regulatory Affairs will be responsible for developing, implementing, and providing guidance on US and global regulatory strategies to support development...
Working Location: MASSACHUSETTS, WESTBOROUGH; NATIONWIDE Workplace Flexibility: Field For more than 100 years, Olympus has focused on making peoples lives healthier, safer and more fulfilling....
Position Summary: We are seeking a strategic, hands-on Director, Regulatory Affairs to lead regulatory project teams and submission activities across assigned development programs....
Executive Director, Regulatory Affairs & Quality Assurance.
- Waltham, MA
- 9 days ago
- Waltham, MA
- 9 days ago
Executive Director, Regulatory Affairs & Quality Assurance....
Manager, Regulatory Affairs (IVD On-Market/Sustaining)
- Marlborough, MA
- 10 days ago
- Marlborough, MA
- 10 days ago
Manager, Regulatory Affairs (IVD On-Market/Sustaining) San Diego, CA, United States Marlborough, MA, United States We are hiring in our Diagnostics Regulatory Affairs team based out of our San...
Director, Regulatory Affairs, Regulatory Science & Execution
- Boston, MA
- 14 days ago
- Boston, MA
- 14 days ago
This is what you will do: The Regulatory Affairs Director (RAD), Regulatory Science & Execution will be accountable for the development, implementation and maintenance of regulatory strategies for...
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing...
Develop regulatory strategies integrated with cross functional project teams and external stakeholders to facilitate timely subscriptions and approvals for post market regulatory submissions....
Director, Regulatory Affairs - CMC CMC / Technical Operations Cambridge, MA ID: 25R-19 Full-Time/Regular Nearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million....
Job Summary: Akebia is currently expanding its Regulatory team to support early and late-stage assets and is searching for a Senior Director, Regulatory Affairs to support the continued development...
Company Overview: Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc., is a biopharmaceutical company focused on developing innovative solutions for patients and healthcare...
Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases. Beyond our...
management systems for medical device software Comprehensive knowledge of global regulatory requirements for SaMD products Strong understanding of ISO 13485 and other quality management system standards...
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...
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....
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Salary for Director of Regulatory Affairs Jobs in Massachusetts
Required or preferred licenses and certifications for Director of Regulatory Affairs positions.
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
- Assay Development
- Medical Writing
- Scientific Writing
- Drug Development
- Clinical Trials
- Drug Discovery
- Toxicology
- Biotechnology
- Next-Generation Sequencing
- Pharmacovigilance
- Medical Affairs
- Gene Therapy
- ICH GCP
- Internal Audits
- Quality Management Systems
- Quality Systems
- Supplier Auditing
- 21 CFR 820
- ICH Guidelines
- ISO 13485
- GxP
- Change Control
- Medical Device Sales
- Microbiology
- Document Management
- FDA Regulations
- Research and Development
- Resolution
- Standard Operating Procedures
- Product Development
- Engineering
- Strategy Development
- Process Improvement
- Quality Assurance
- Implementation
- Auditing
- Verbal Communication
- Written Communication
- Mentoring
- Collaboration
- Documentation
- Coaching
- Interpersonal Skills
- Reporting
- Education Experience
- Bachelor's Degree
- Filing
- Regulations
- Microsoft PowerPoint
- Policy Development
- Project Management
- Problem Solving
- Microsoft Excel
- Research Skills
- Staff Supervision
- Organization
- Scheduling
- Leadership
- Communication Skills
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