VP Quality Assurance and Regulatory Affairs (QA/RA)

Company Overview

Nurami Medical Ltd. is a dynamic and fast-growing startup revolutionizing soft tissue surgical repair. Through proprietary engineering of nanofibers with biomaterials, we create multi-functional biomimetic tissue scaffolds. This approach enables previously impossible patient benefits at both the cellular and surgeon surgical levels by overcoming trade-offs inherent in collagen or traditional synthetics.  

Our mission is to redefine surgical solutions, enhance patient outcomes, and set new standards for healthcare innovation.

We specialize in designing and delivering breakthrough dural reconstruction products for soft tissue surgery, initially in cranial and spinal surgery. Products include in-market (ArtiFascia) and soon to be clinical stage (ArtiFix).

Join our pioneering team and be part of the future of soft tissue repair!

Position Overview

We are seeking a highly skilled and motivated VP Quality Assurance (QA) and Regulatory Affairs (RA) to establish and lead the QA function in our organization, and steer global regulatory submissions and compliance. This role is critical to ensuring that our commercial product (class II\III implantable device) and our innovative, R&D stage product which is poised to begin clinical trials (PMA), meet the highest standards of quality, safety, and regulatory compliance.

You will have the unique opportunity to build the QA framework, establish our QMS, drive quality culture across the organization, and directly impact the development of groundbreaking medical technologies.

This position reports directly to the CEO.

Key Responsibilities

1. Quality Management System (QMS) Development and maintenance:

- Design, implement, and maintain a robust QMS in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements for Nurami’s commercial products and Nurami’s R&D-stage products.

  - Establish SOPs, policies, and documentation to support quality and compliance initiatives.

2. Regulatory Compliance:

- Ensure all products meet domestic and international regulatory requirements, including FDA and MDR (CE).

- Act as the primary liaison with regulatory authorities and lead ISO 13485 and FDA audits and inspections.

- Implement regulatory strategies for product development and approval.

- Lead the preparation and submission of regulatory filings, such as 510(k), PMA, and CE Mark, or other regional submissions.

- Maintain compliance with post-market surveillance requirements.

3. Product Quality Oversight:

- Collaborate with R&D and manufacturing teams to establish quality standards and specifications for new products.

- Oversee testing, validation, and risk management processes to ensure product safety and efficacy.

4. Team Leadership:

  - Build and manage a high-performing QA/RA team as the company grows.

  - Provide training and mentorship to foster a culture of quality across the organization.

5. Continuous Improvement:

- Monitor and analyze quality metrics to identify trends and implement corrective and preventive actions (CAPAs).

  - Drive initiatives to enhance processes, reduce defects, and improve operational efficiency.

6. Supplier and Vendor Management:

  - Develop and oversee supplier quality programs to ensure materials meet required standards.

  - Conduct audits of key suppliers and vendors to maintain compliance.

7. Support label expansion of the commercial product

Qualifications:

- Bachelor’s degree in engineering, life sciences, or a related field (advanced degree preferred).

- Minimum of 8 years of experience in quality assurance within the medical device, biotechnology, or related industry.

- Proven expertise in developing and managing QMS for medical devices, including ISO 13485 and FDA regulations.

- Strong knowledge of risk management practices (ISO 14971) and product lifecycle quality processes.

- Experience with regulatory submissions and audits.

- Proven experience with PMA process

- Excellent leadership and organizational skills.

- Good communication skills, both verbal and written in English

- Strong interpersonal skills and team player

- Hands-on, proactive approach with the ability to thrive in a fast-paced startup environment.

Preferred Qualifications:

- Experience working with biomaterials or biopolymer-based medical devices.

- Knowledge of EU MDR/IVDR, FDA and other international regulatory frameworks.

- ASQ certifications (e.g., CQE, CQA) or equivalent credentials.

Why Join Us?

- An opportunity to shape the QA function in a high-impact role.

- Be part of a mission-driven team dedicated to transforming innovative healthcare products

- Join a collaborative, innovative and diverse startup culture.

To apply - please send your updated CV along with a brief cover letter to [email protected] , using the job title as the subject line.