Senior Manager of Quality and Regulatory AffairsCompany: Delasco
Employment Type: Full-Time | Exempt
Work Arrangement: Onsite with flexibility to work remotely
one day per weekSalary Range: $130,000-$150,000 annually
Delasco is seeking a Senior Manager of Quality and Regulatory Affairs to lead our quality and regulatory programs, strengthen our Quality Management System (QMS), and ensure compliance with applicable federal and state regulations.
This is an exciting opportunity for a strategic, hands-on leader who enjoys collaborating across teams, solving complex challenges, and making a meaningful impact on business operations.
What You'll Do- Lead Quality & Regulatory Strategy: Oversee quality management and regulatory compliance initiatives, ensuring alignment with company goals and industry standards.
- Drive Continuous Improvement: Develop and enhance our QMS, lead CAPA programs, internal audits, supplier qualifications, and process improvements.
- Ensure Regulatory Compliance: Manage FDA, DEA, and state registrations, licensing, regulatory inspections, and reporting requirements.
- Oversee Product Quality & Safety: Lead complaint investigations, Medical Device Reporting (MDR), product recalls, and quality control activities.
- Serve as a Regulatory Expert: Monitor evolving regulations, maintain critical documentation, and ensure compliance across product labeling and marketing materials.
- Develop & Inspire Your Team: Mentor Quality and Regulatory Affairs employees, provide training, and partner with leadership to promote a strong culture of quality.
What You'll Bring- Bachelor's degree in Science, Engineering, or a related field; an equivalent combination of education and experience may be considered.
- 10+ years of Quality and Regulatory Affairs experience in a cGMP-regulated manufacturing environment, including medical devices, pharmaceuticals, cosmetics, or healthcare.
- 3+ years of supervisory or management experience.
- Strong knowledge of FDA Quality Management System Regulation (21 CFR Part 820) and ISO 13485, ISO 9001, or ISO 22716.
- Experience with electronic QMS/document control systems such as Ensur, Veeva Vault, or TrackWise.
- Knowledge of risk management, regulatory compliance, quality systems, and continuous improvement.
- Excellent leadership, communication, analytical, and problem-solving skills.
Compensation & BenefitsAt Delasco, we value our employees and offer a competitive compensation and benefits package designed to support your professional and personal well-being.
What We Offer:- Competitive Salary: $130,000-$150,000 annually
- Flexible Work Arrangement: Primarily onsite with the flexibility to work remotely one day per week
- Health & Wellness: Medical, dental, and vision insurance
- Retirement Benefits: 401(k) with company match
- Paid Time Off: PTO to support work-life balance
- Floating Holiday: Additional flexibility to take time off for a day that's meaningful to you
- Paid Company Holidays: 9 paid company holidays annually
At Delasco, quality is at the heart of what we do. As our Senior Manager of Quality and Regulatory Affairs, you'll play a key role in shaping our quality and regulatory strategies, collaborating with leaders across the organization, and driving continuous improvement.
We're looking for a leader who brings expertise, initiative, and a commitment to excellence-and who is excited to make a lasting impact.
Ready to take the next step in your career?Apply today and become part of the Delasco team!
