Quality and Compliance Director/Manager

DermaSensor, Inc Quality and Compliance Director/Manager

Miami, FL · Full time

We are seeking a Quality and Compliance Director/Manager to join our team. This position will work collaboratively with all stakeholders in the organization. Join our startup at the ground floor to lead our global product quality and regulatory efforts. In this role, the Quality and Compliance Manager/Director will provide quality leadership across key departments in the development of hardware and software medical devices. In joining our team, you’ll enjoy competitive compensation and a creative and flexible work environment. Actual title will be determined based on experience and qualifications.

Description

The Quality and Compliance Director/Manager shall solely be responsible for performing the duties of, and acting as, the Quality unit of the company by performing the following responsibilities:

• Own and maintain the company’s quality management system and ensure the company is regulatory inspection ready at all times (FDA, Notified Body, international regulatory bodies).
• Provide quality leadership and guidance across key departments on quality standards such as 21 CFR 820, ISO 13485, IEC 62304, ISO 14155, HIPAA, GDPR, CCPA, ISO27001, and SOC2.
• Plan, coordinate, and direct quality compliance strategies for new products worldwide.
• Manage quality control, quality assurance, calibration, complaint handling, document control, employee training, and approved suppliers.
• Ownership of the Corrective / Preventive Action (CAPA) process and direct investigations to resolve complaints and non-compliance instances.
• Implement corrective action plans to correct non-compliance issues.
• Author and manage SOPs for compliance to applicable standards.
• Initiate and manage document control processes and engineering change orders.
• Author and compile regulatory submissions, technical files, audit packages, and design and development plans.
• Provide quality management system guidance for clinical research activities and documentation such as CERs.
• Coordinate and facilitate necessary validations through independent testing laboratories.
• Oversee post-market activities and feedback collection and investigation.
• Act as the safety officer (or similar) for international authorized representative subsidiaries.
• Act as the cybersecurity Security Officer.

Requirements

• Extensive working knowledge of ISO 13485:2016, IEC 62304, QSR, Class II+ regulatory pathways, HIPAA, GDPR, CCPA, ISO27001, and SOC2.
• A thorough understanding of cGMP and FDA & MDR guidelines for Class II+ products.
• Comprehensive knowledge of electronic hardware and software-based development and manufacturing practices.
• 5+ years regulatory compliance/quality systems/regulatory submissions experience with digital medical devices, electronic hardware, and embedded and mobile software.
• Extensive experience working with the FDA and international agencies regarding new product registration requirements, inspections, submissions, and follow up.
• A degree in a science or engineering discipline (preferably an educational background in electrical, industrial, mechanical, or healthcare engineering).
• Self-sufficient and able to work and make decisions independently.
• Strong analytical and problem-solving skills.
• High attention to detail including proven ability to manage multiple, competing priorities simultaneously.
• Collaborative, team-first attitude – maximizing team performance and value ideas on their merits.
• Ability to collaborate with team members under pressure and iterate quickly.
• Strong interpersonal and leadership skills.
• Superior verbal and written communication skills.