Regulatory Affairs and Quality Assurance (RAQA) Engineer

Reports to: VP of RAQA

Responsibilities:

• Ensure compliance with regulatory requirements (ISO 13485, MDR 2017/745, FDA 21 CFR Part 820).
• Handle and support change orders, corrective and preventive actions, non-conforming products, complaint handling, and calibrations.
• Manage document and record control in the eQMS.
• Conduct internal audits.
• Manage supplier relationships, including audits, approval, evaluation, and routine contact.
• Support product and process V&V activities.
• Support design control processes for R&D projects.
• Participate in risk management activities.
• Prepare documentation for new product regulatory submissions and changes.
• Develop and update company procedures and work instructions.
• Gather data for trend analysis and quality KPI’s.
• Maintain device product files (DMR, DHF).
• Handle and maintain employee training.
• Perform gap assessments of regulatory standards.
• Perform product release QA activities.
• Participate in and prepare for external audits by Notified Bodies, FDA, and other regulatory authorities.
• Provide QARA assistance, guidance, and support to all departments.

Qualifications:

• Bachelor’s degree in a relevant scientific or engineering field.
• 4+ years of RA/QA experience in a medical device company.
• Experience in medical device manufacturing processes and cleanrooms.
• Experience with Class III implants (preferred).
• Experience in medical device manufacturing and post-market activities for the EU and US markets (preferred).
• Lead Auditor certificate (preferred).
• Strong analytical, problem-solving, and communication skills.
• Attention to detail and commitment to quality.
• Ability to work independently and under pressure.
• Team player.
• Proficiency in English (written and verbal).