Senior Manager, QA & Regulatory Affairs
Mesa Laboratories, Inc.•San Diego, CA
•$154,500 - $193,250•Onsite
About The Position
The Senior Manager, Quality & Regulatory Affairs is responsible for overseeing the development, implementation, and continuous improvement of the organization’s Quality Management System (QMS) and Regulatory Affairs programs. This role ensures product quality, regulatory compliance, and customer satisfaction while driving operational efficiency across the enterprise. The Senior Manager leads cross-functional quality and regulatory initiatives, manages audit readiness and regulatory submissions, and develops a high-performing team that supports business objectives and global compliance requirements.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related discipline.
- 8–10 years of progressive experience in Quality Assurance and/or Regulatory Affairs including 4–5 years of people management experience leading managers and/or cross-functional teams.
- Strong knowledge of Quality Management Systems and regulatory compliance frameworks.
- Demonstrated ability to lead audit programs, CAPA systems, and compliance initiatives.
- Proven leadership skills with experience developing and mentoring high-performing teams.
- Excellent analytical, problem-solving, and decision-making capabilities.
- Effective communication and influencing skills across all organizational levels.
- Ability to balance strategic leadership with operational execution.
Responsibilities
- Oversee the design, implementation, and maintenance of the Quality Management System to ensure compliance with applicable standards and regulations.
- Establish quality objectives, metrics, and performance indicators aligned with business goals.
- Lead the integration of quality principles across product lifecycle activities, including design, manufacturing, and post-market support.
- Direct regulatory affairs strategies to support product development, market access, and lifecycle management.
- Ensure compliance with applicable global regulatory requirements and standards.
- Oversee regulatory submissions, change notifications, and communications with regulatory bodies, as applicable.
- Lead, mentor, and develop managers and individual contributors within Quality Assurance and Regulatory Affairs.
- Set performance expectations, conduct performance and compensation reviews, and support succession planning.
- Foster a culture of accountability, continuous improvement, and compliance excellence.
- Ensure audit readiness and lead internal and external audits, inspections, and regulatory assessments.
- Drive timely and effective responses to audit observations, nonconformances, and regulatory findings.
- Identify quality and compliance risks and implement mitigation strategies.
- Lead root cause investigations and oversee corrective and preventive action programs.
- Ensure systemic issues are addressed to prevent recurrence and improve product and process quality.
- Monitor effectiveness of CAPAs and continuous improvement initiatives.
- Partner with Engineering, Operations, Supply Chain, R&D, and Commercial teams to embed quality and regulatory requirements into business processes.
- Provide strategic guidance on quality and regulatory considerations for new and existing products.
- Lead quality and efficiency improvement initiatives using data-driven methodologies.
- Promote standardization, simplification, and scalability of quality and regulatory processes.
- Champion continuous improvement culture aligned with organizational values.
- Prepare and present quality and regulatory performance updates to senior leadership.
- Use metrics and trend analysis to inform decision-making and strategic planning.
Benefits
- Competitive wages
- Potential bonus opportunities
- Equity awards
- Commission
- Tiered Medical, Dental and Vision Insurance options
- Health savings (HSA) accounts
- Healthcare & dependent care flexible spending (FSA) accounts
- Company paid short term and long-term disability
- Company paid life insurance and AD&D
- Flexible Time Off Policy
- Paid sick leave of 48 hours per calendar year
- Eligible employees may receive four (4) weeks paid Care Giver leave after 1 year of service or in accordance with state leave laws
- 401(k) plan that provides a 4% Safe Harbor company match on a 4% employee contribution that begins on Day 1
- Employee Wellness and Financial Assistance Resources through Cigna and NY Life
- Nine (9) paid company holidays per year
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What This Job Offers
Job Type
Full-time
Career Level
Senior
