Description

You design manufacturing processes, production layouts, and equipment installation procedures to optimize assembly and material handling while owning technical documentation for regulatory submissions and validation reports.

This role is on-site.

Responsibilities

• Design machine arrangements and operation sequences to maximize plant productivity.
• Develop manufacturing processes applicable to statistical process control.
• Execute IQ, OQ, and PQ validation reports and maintain risk documentation.
• Manage regulatory submissions including FDA 510(k), PMA, and EU MDR technical documentation.
• Investigate machinery performance and initiate corrective actions to maintain product quality.

Required Skills

• 5+ years of experience in manufacturing operations or regulatory engineering.
• Expertise in FDA 510(k) and PMA submissions.
• Experience with international product registration support across APAC, LATAM, EMEA, and Canada.
• Proficiency in regulatory bodies including HAS, CFDA/NMPA, TFDA, PMDA, Anvisa, ANMAT, MFDS, MOHW, SFDA, and MOH.
• Hands-on experience with IQ, OQ, and PQ validation protocols.
• Knowledge of manufacturing process and design controls.
• Proficiency using SAP for material and part management.
• Strong technical writing skills for STEG preparation and regulatory license renewals.

Preferred Skills

• RAC Certification for Medical Devices.
• Experience with US and EU submissions, CE Technical Files, and EU MDR gap analysis.
• Knowledge of collateral and product-specific IEC Standards.

Key Skills

Education

Any Gradute