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.
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
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