QA/RA Specialist

Role Description:

·       Provide direction and practical assistance to the Research and Development team throughout product development and documentation (Specifications, Verification & Validation, Engineering Change Orders, Design Reviews).

·       Quality Management System (QMS) Oversight:

-       Support the implementation, maintenance, and continuous improvement of the company’s QMS in compliance with ISO 13485, FDA 21 CFR Part 820 and other relevant regulations.

-       Ensure effective document control for all quality-related documentation, including specifications, testing procedures, and records.

-       Managing company training and qualification quality

-       Perform critical evaluations of suppliers, conduct internal quality audits, and manage external regulatory inspections to confirm adherence to standards.

·       Assist with regulatory submissions

- Create and approve regulatory documents submitted to regulatory authorities

-       Act as the point of contact on regulatory information related to the company’s work for external customers.

-       Supervise RA activities to ensure that documentation in support of premarket submissions to obtain clearance/approval.

·       Supervise risk management activities, encompassing risk identification and the implementation of mitigation plans.

Requirements:

·       Bachelor’s degree in Life Sciences, Engineering, Biotechnology, Chemical Engineering, Quality Assurance, or a related field.

• Three to five years of quality assurance and regulatory affairs experience within the medical device sector.
• knowledge of FDA (FDA 510(k) experience a plus) Quality System requirements, ISO 13485 (Quality System) requirements, ISO 14971 (Risk Management) requirements, and IEC 62304, Medical Device Software – Software Life Cycle processes

·       Knowledge of information security standards and privacy regulations – an advantage

·       Highly motivated, self-learner

·       Self-starter with ability to work independently, while also collaborating with cross-functional teams

• Ownership mindset with a logical, methodical approach to prioritizing tasks and responsibilities

·       Excellent English – fluent in reading, writing, and verbal communication