Lean Manager & Regulatory Affairs

Job Summary:

The Lean Manager & Regulatory Affairs is responsible for driving operational excellence through Lean methodologies while ensuring full compliance with applicable regulatory requirements. This dual-role position combines strategic process improvement with regulatory oversight, supporting both efficiency and product conformity across the organization.

Key Responsibilities:

Lean Management:

• Lead Lean transformation initiatives across production, quality, and support functions.
• Identify and eliminate waste, reduce process variability, and improve value streams using Lean tools.
• Facilitate cross-functional workshops and training sessions to embed a culture of continuous improvement.
• Monitor KPIs and implement corrective actions to improve operational performance.
• Collaborate with leadership to align Lean initiatives with business goals.

Regulatory Affairs:

• Ensure compliance with relevant regulations and standards.
• Prepare and manage regulatory submissions, technical documentation, and declarations of conformity.
• Liaise with notified bodies and regulatory authorities for audits, inspections, and certifications.
• Monitor regulatory changes and assess their impact on business operations and product compliance.
• Support product development and lifecycle management from a regulatory perspective.

Qualifications:

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field.
• Minimum 5 years of experience in Lean management and regulatory affairs, preferably in manufacturing, medical devices, or PPE.
• Strong knowledge of Lean principles and regulatory frameworks.
• Proven experience in leading cross-functional improvement projects.
• Excellent analytical, communication, and project management skills.
• Fluent in English; additional languages are a plus.

L'offerta è rivolta a candidati ambosessi nel rispetto del D.lgs 198/2006 e ss.mm.ii. e dei Decreti legislativi n. 215 e 216 del 2003 sulla parità di trattamento. Si invitano i candidati a prendere visione dell'informativa privacy (art.13 e 14, Reg EU 679/2016) pubblicata sul sito . Etjca S.p.A. (Aut. Min. Prot. N. 1309-SG del 23/02/2005)