Description

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

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