About Us:
We are an innovative medical device start-up focused on restoring upper extremity function for stroke patients. With a newly qualified manufacturing facility and plans to scale production, we are seeking a Head of Quality Assurance and Regulatory Affairs to ensure compliance and excellence in quality and regulatory practices.
Position Overview:
The Director of Quality Assurance and Regulatory Affairs will oversee the quality management system (QMS), ensure compliance with global medical device regulations, and provide strategic leadership to the quality and regulatory teams. This role requires a hands-on approach to quality and regulatory functions, focusing on maintaining compliance, fostering innovation, and driving operational improvements.
Key Responsibilities:
- Quality Management System (QMS):
- Maintain and improve the QMS to ensure compliance with global medical device regulations, including ISO 13485 and FDA 21 CFR Part 820
- Ensure timely updates to policies and procedures to align with regulatory changes and industry best practices
- Leadership and Team Development:
- Lead, mentor, and develop a team of quality engineers and specialists to achieve organizational goals
- Foster a culture of quality, compliance, and continuous improvement across the organization
- Manufacturing and Supplier Performance:
- Partner with the manufacturing team to drive improvements in supplier performance and manufacturing efficiency
- Enhance inspection and test methods throughout the production process in collaboration with manufacturing and engineering teams
- Product Development and Compliance:
- Ensure that product development activities incorporate quality requirements, including user need validations, regulatory compliance, and design change approvals
- Analyze design and engineering changes to develop regulatory strategies and ensure compliance throughout the product lifecycle
- Complaint Handling and Device Investigations:
- Manage the complaint handling and material review board processes to ensure thorough investigations and timely closure of issues
- Provide technical leadership for hands-on device failure investigations, identifying root causes and implementing corrective actions
- Audits and Compliance:
- Lead and participate in audits of potential suppliers and internal operations to ensure adherence to quality and regulatory standards
- Develop and implement corrective actions to address audit findings and improve overall compliance
Qualifications:
- Bachelor’s degree in Engineering, Quality Management, Regulatory Affairs, or a related field; advanced degree preferred
- Minimum of 10-15 years of experience in quality and regulatory roles within the medical device industry, with hands-on experience in electromechanical devices
- Proven success in building and leading teams, with a focus on direct people leadership and development
- Strong knowledge of global medical device regulations, including FDA and ISO/CE standards
- Experience managing QMS compliance, regulatory submissions, and product lifecycle management
- Excellent problem-solving, analytical, and communication skills
- Proficiency in leading cross-functional teams and driving organizational improvements
- Certification in quality or regulatory fields (e.g., CQE, CQA, RAC) is a plus
Why Join Us:
- Opportunity to lead quality and regulatory strategies for innovative medical devices
- Collaborative and mission-driven work environment
- Competitive compensation and benefits package
- Professional growth and leadership development opportunities
Please note that the salary information is a general guideline only. Neurolutions considers factors such as the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, and internal equity, as well as location, market, and business considerations when extending an offer.
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