Manager, QA & Regulatory Affairs

Mesa Labs Career•San Diego, CA

8d•Onsite

About The Position

The Manager, Quality Assurance & Regulatory Affairs is responsible for managing day-to-day Quality Assurance and Regulatory Affairs activities to support product quality, regulatory compliance, and effective execution of the Quality Management System (QMS). This role leads a team of quality and/or regulatory professionals, translates department priorities into operational plans, and ensures assigned quality and regulatory programs are executed consistently and effectively. The Manager partners with Engineering, Operations, Supply Chain, R&D, Commercial, and other functions to resolve quality and compliance issues, support product lifecycle activities, and drive continuous improvement.

Requirements

Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related discipline, or equivalent combination of education and experience.
Typically 6-8 years of progressive experience in Quality Assurance and/or Regulatory Affairs within a regulated environment.
Typically 2-3 years of people leadership, supervisory, team lead, or other demonstrated leadership experience.
Experience working with cross-functional teams and managing multiple quality or regulatory priorities.
Strong working knowledge of Quality Management Systems and applicable regulatory compliance frameworks.
Experience with audits, CAPA, nonconformance management, change control, risk management, and related quality processes.
Working knowledge of regulatory requirements and product lifecycle activities applicable to the business.
Demonstrated people leadership skills, including coaching, performance management, prioritization, and team development.
Strong analytical, problem-solving, and decision-making skills with the ability to resolve moderately complex issues and escalate higher-risk matters appropriately.
Strong communication and influencing skills with the ability to collaborate effectively across functions and organizational levels.
Ability to translate department objectives into operational plans, priorities, and measurable team results.
Strong organizational and project management skills with the ability to manage competing priorities and deadlines.

Responsibilities

Manage the implementation, maintenance, and ongoing effectiveness of assigned elements of the Quality Management System in accordance with applicable standards, regulations, and company requirements.
Translate quality objectives and department priorities into team goals, work plans, and measurable activities.
Monitor quality metrics and trends, identify issues, and implement appropriate actions to improve performance.
Partner with cross-functional teams to ensure quality requirements are incorporated into product lifecycle and operational activities.
Manage assigned regulatory activities supporting product development, market access, product changes, and lifecycle management.
Ensure regulatory activities are completed in accordance with applicable global requirements, standards, and internal procedures.
Coordinate regulatory submissions, change notifications, registrations, and communications with regulatory bodies as applicable.
Assess regulatory requirements and provide guidance to cross-functional partners on routine and moderately complex regulatory matters.
Lead, coach, and develop Quality Assurance and/or Regulatory Affairs employees, establishing clear priorities, expectations, and accountability.
Assign work, monitor progress, and balance team resources to meet operational and project requirements.
Conduct performance discussions, support employee development, and address performance concerns in partnership with Human Resources as appropriate.
Build team capability through coaching, knowledge sharing, and development opportunities.
Foster a culture of quality, compliance, collaboration, and continuous improvement.
Maintain audit and inspection readiness for assigned areas and support internal and external audits, inspections, and regulatory assessments.
Coordinate responses to audit observations, nonconformances, and regulatory findings, ensuring actions are completed accurately and on time.
Identify quality and compliance risks within assigned areas and escalate significant issues as appropriate.
Support implementation of risk mitigation activities and monitor effectiveness.
Manage or support root cause investigations and corrective and preventive action activities for quality and compliance issues.
Ensure investigations are appropriately documented, actions address identified causes, and commitments are completed within required timelines.
Monitor CAPA effectiveness and identify recurring issues or trends requiring additional action.
Partner with cross-functional teams to improve product and process quality and prevent recurrence of quality issues.
Partner with Engineering, Operations, Supply Chain, R&D, Commercial, and other functions to resolve quality and regulatory issues and support business objectives.
Provide practical quality and regulatory guidance for new and existing products, processes, and operational changes.
Participate in cross-functional projects and ensure quality and regulatory requirements are understood and incorporated into project plans.
Communicate significant quality, compliance, and regulatory issues to appropriate stakeholders and management.
Lead or support improvement initiatives within assigned quality and regulatory processes using data and established continuous improvement methods.
Identify opportunities to improve efficiency, consistency, documentation, and compliance.
Implement standardized processes and tools that improve team effectiveness and scalability.
Promote continuous improvement and problem-solving within the team.
Prepare and communicate quality and regulatory metrics, trends, risks, and program status to management and cross-functional stakeholders.
Analyze data to identify trends, support decisions, and recommend actions within assigned areas.
Maintain clear and timely communication regarding quality events, regulatory activities, project status, and emerging risks.

Benefits

Competitive wages
Potential bonus opportunities
Equity awards
Commission
Comprehensive benefits package
Tiered Medical, Dental and Vision Insurance options
Health savings (HSA)
Healthcare & dependent care flexible spending (FSA) accounts
Company paid short term and long-term disability (unless covered by a state disability plan)
Company paid life insurance and AD&D
Flexible Time Off Policy
Paid sick leave of 48 hours per calendar year
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