Senior Quality and Regulatory Specialist

About the Company:

Our mission, in a single line, is to help people live longer and healthier lives. This mission defines and guides everything we do and everything that we hope to do:). Our aim is not only to expand lifespans, but more importantly, to expand health spans, by enabling people to live life of the quality that they desire.

Prior to the 21st century, the three traditional frontiers were considered to be land, sea and air. We believe that the most important frontier in the 21st century is the human body itself, and therefore the focus of our company is to look inwards, into the human body - which for us is the Fourth Frontier.

We have picked heart health as our primary focus area, since cardiovascular disease is the leading cause of mortality across the globe. Despite its importance, affordable products and services to monitor and improve heart health from the comfort of your home have not been available to consumers. Fourth Frontier is committed to solving this important problem.

Quality and Regulatory Specialist

Key Areas of Responsibility:

• Quality Management System (QMS) Management:

  Maintain the QMS to ensure the efficiency of the document control process and compliance with company procedures and related standards.

• Compliance and Audits:

  Lead QMS compliance with both internal procedures and external regulations. You'll ensure adherence to

  21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, and EU MDR

  , along with other country-specific requirements. You'll also take the lead on audits and inspections by regulatory bodies and internal quality teams, preparing for them and ensuring documentation is ready.

• Corrective and Preventive Action (CAPA) and Non-Conformance (NC) Management:

  Lead CAPA investigations from issue identification through to root cause analysis, resolution, and effectiveness checks. You will also directly assist CAPA and NC owners to ensure their records are complete and comply with standards such as

  21 CFR Part 820, ISO 13485, ISO 14971, and HIPAA

  .

• Data Analysis & Improvement:

  Analyze trends in non-conformances and CAPA data to identify systemic issues and contribute to continuous improvement initiatives. You'll also prepare monthly metrics, maintain logs, and send reminders for required activities.

• Product Lifecycle Support:

  Provide essential quality and regulatory support throughout the medical device lifecycle. This includes managing documentation for

  Software as a Medical Device (SaMD)

  , supporting periodic software releases, and handling post-market activities.

• Cybersecurity and Data Privacy Compliance:

  Maintain a foundational understanding of an

  Information Security Management System (ISMS)

  , and ensure the company's QMS and product documentation adhere to relevant security and privacy laws and regulations.

• Cross-functional Collaboration:

  Work closely with cross-functional teams to uphold a consistent and compliant approach to quality. You will draft regulated documentation and assist with quality improvement initiatives across the organization.

Essential skills, qualifications and experience:

• Regulatory Knowledge:

  In-depth understanding of medical device regulations, including

  21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, and EU MDR

  .

• QMS Expertise:

  Proven, hands-on experience in managing and improving a QMS, with a strong grasp of document control processes and how to maintain product-related quality documentation.

• Auditing:

  Experience leading audits and inspections by regulatory bodies. The ability to manage deliverables, track corrective actions, and ensure timely closure is essential.

• CAPA/NC Management:

  Direct experience leading CAPA investigations from root cause analysis through to resolution and effectiveness checks. You must have the ability to ensure documentation for CAPAs and NCs complies with various standards, including

  HIPAA

  .

• Data Analysis:

  Strong analytical skills to analyze trends in quality data and identify systemic issues.

• Communication:

  Excellent communication and collaboration skills to work effectively with various teams and external parties.

• Education:

  Bachelor's degree in a relevant field (e.g., Engineering, Life Sciences).
• Minimum of 3-5 years of experience in a Quality or Regulatory role within the medical device industry.
• Prior experience with

  EU MDR

  is required.
• Demonstrated experience managing and drafting regulated documentation.
• Experience with pre-market and post-market activities for medical devices.
• Basic understanding of medical device production activities.

Desirable

What We Offer

• Opportunity to work with a pioneering healthcare technology company.
• Collaborative and innovation-driven work culture
• Exposure to global healthcare markets and cutting-edge medical solutions.