DermaSensor, Inc Director of Quality and Regulatory Affairs Miami, FL · Miami, FL · Remote · Full time

We are seeking a Director of Quality and Regulatory Affairs to join our team. This position reports to the company’s CEO and 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 Director of Quality and Regulatory will provide quality and regulatory 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.

Description

The Director of Quality and Regulatory Affairs shall solely be responsible for performing the duties of, and acting as, the Quality and Regulatory 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 RA/QA leadership and guidance across key departments on quality standards such as 21 CFR 820, ISO 13485, IEC 62304, and ISO 14155
  • Plan, coordinate, and direct regulatory strategies for new products worldwide
  • Manage regulatory affairs, quality control, quality assurance, calibration, complaint handling, document control, and employee training
  • 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 compile regulatory submissions and technical files
  • Provide quality and regulatory 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
  • Review and approval of new vendors
  • Act as the safety officer (or similar) for international authorized representative subsidiaries
  • Assist the company with managing and enforcing of other business compliance matters such as HIPAA/GDPR/CCPA


Requirements

Extensive working knowledge of ISO 13485:2016, IEC 62304, QSR, and Class II+ regulatory pathways

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