QA/RA Specialist

About the Role

As a QA/RA Specialist, you’ll join a small, high-performing team developing innovative single-use surgical fixation systems. You will work closely with the Quality & Regulatory leader, supporting a wide range of QA and RA activities. This is a unique opportunity to take ownership of critical processes, grow with the company, and help shape the foundation of our quality and regulatory systems.

Key Responsibilities

Quality Assurance & Control

• Support quality inspection activities for incoming, in-process, and final product
• Assist in managing quality documentation, calibration records, and internal audits
• Participate in the handling of nonconformances, CAPAs, complaints, and root cause investigations
• Maintain change control documentation and support process improvements
• Collaborate with manufacturing partners and suppliers to ensure product and process quality
• Assist in supplier qualification and audits
• Contribute to trend analyses and continuous improvement initiatives

Regulatory Affairs

• Assist with preparation and maintenance of regulatory submissions (EU MDR, FDA, etc.)
• Support internal compliance with ISO 13485, FDA QSR, and other relevant standards
• Maintain regulatory documentation and records for product files and technical files
• Help monitor and interpret regulatory updates and communicate key changes to the team
• Liaise with external partners, auditors, and consultants under the guidance of the manager

Requirements

• More than 5 years of experience in a QC/QA/RA role, ideally within medical devices (Class I/II/III)
• Familiarity with:
• ISO 13485 and FDA 21 CFR Part 820
• MDR Regulation (EU) 2017/745 documentation and requirements
• Risk management (ISO 14971)
• Medical device packaging and sterilization requirements
• Document control and QMS software (Greenlight Guru is a plus)
• Strong attention to detail and organizational skills
• Able to work independently, take initiative, and manage time effectively
• Proficient in English; strong communication skills, both written and verbal

What We Offer

• A dynamic and flexible work environment where autonomy is encouraged
• A role with broad exposure across the entire product lifecycle
• The chance to work with experienced professionals and make a real impact
• Opportunities for learning and professional growth as the company scales