Senior Quality Engineer – Material Reinvent
Solventum
Senior Director, Quality Assurance and Regulatory Affairs – Endoscopy
Medtronic
full-time
Posted on:
Location Type: Hybrid
Location: Lafayette • California, Colorado, Minnesota • 🇺🇸 United States
Visit company websiteSalary
💰 $217,600 - $366,000 per year
Job Level
Senior
About the role
- Lead a global team responsible for the Regulatory and Quality needs of a diverse and technologically advanced portfolio
- Build organizational capability through mentoring, succession planning, and professional development while fostering a culture of continuous improvement and regulatory excellence
- Establish clear performance metrics, develop team capabilities, and implement strategies to attract, retain, and grow top talent in quality and regulatory disciplines
- Build strong regulator relationships
- Develop and execute global regulatory strategies to support product approvals, new market entries, and portfolio expansion
- Ensure timely and high-quality regulatory submissions and interactions with global health authorities
- Deeply understand and can articulate how regulatory creates value
- Translate scientific information to regulatory strategy
- Serve as the primary regulatory advisor to cross-functional teams and executive leadership
- Experience leading through challenging situations (e.g., Warning Letter remediation)
- Develop and implement OU Quality strategy and plans that drive significant improvements, and are aligned with OU, Region, GOSC Quality and Enterprise strategic priorities
- Responsible for the global quality system (QMS) for Endoscopy, ensuring compliance with ISO, FDA, and other international regulatory standards
- Lead quality initiatives to support product lifecycle management, manufacturing scale-up, and continuous improvement ensuring the highest reliability in new product introduction programs according to DRM principles
- Establish quality metrics and drive a culture of accountability, inspection readiness, and operational excellence
- Direct the internal and external audit program within Endoscopy, ensuring inspection readiness, managing notified body relationships, and overseeing successful regulatory agency inspections
- Partner with R&D, Clinical, Operations, and Marketing to influence product development and commercialization strategies from a regulatory and quality perspective
- Collaborate with regional QA/RA teams to ensure alignment and consistency in quality and regulatory practices worldwide
Requirements
- Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or related field
- 15+ years of relevant progressive experience in Quality Assurance and Regulatory Affairs within the medical device industry or an advanced degree with a minimum of 13 years of relevant progressive experience in Quality Assurance and Regulatory Affairs within the medical device industry
- 10+ years of people leadership, including global team management
- Demonstrated experience with FDA, EU MDR, and global regulatory submissions and inspections
- Advanced degree (MS, PhD, RAC certification, or MBA) is nice to have
- Experience working in a global matrixed MedTech organization is nice to have
- Knowledge of gastrointestinal diagnostics or endoscopy is nice to have
- Strong communication, leadership, and cross-functional collaboration skills is nice to have
- Understanding of Medical AI fundamentals – how AI is applied in areas like diagnostics, clinical decision support, imaging, etc. is nice to have
- Familiarity with evolving regulatory landscapes, especially FDA requirements related to AI is nice to have
- Awareness of the AI lifecycle – including risks like bias, drift, and overfitting is nice to have
- Ability to navigate uncertainty – building regulatory strategies to manage AI-related risks and ensure compliance is nice to have
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement
- Capital Accumulation Plan
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory strategyquality management system (QMS)regulatory submissionsFDA complianceEU MDR complianceaudit managementproduct lifecycle managementcontinuous improvementdata analysisrisk management
Soft skills
leadershipmentoringcommunicationcross-functional collaborationorganizational capabilitystrategic planningproblem-solvingrelationship buildingaccountabilityadaptability
Certifications
RAC certificationBachelor’s degreeMaster’s degreePhDMBA
