Launch & Regulatory Compliance Project Lead (Manufacturing & Healthcare)

Stefanini LATAM; Estado de México; Híbrido; MXN 540,000 - 901,000; Jornada completa

Descripción de la vacante

A leading healthcare and manufacturing firm is seeking a Launch & Regulatory Compliance Project Manager in Mexico. The role involves overseeing product launches, ensuring compliance with regulations, and effective project management. Candidates should have a bachelor’s degree in Industrial Engineering or a related field, plus at least 2 years of experience in project management. Fluency in Spanish and English is required. The position offers a hybrid work model along with various employee benefits.

Servicios

Law Benefits + PTU

Hybrid Job

Company Equipment

Attendance Bonus

Punctual Bonus

Food Vouchers

Restaurant Vouchers

Personnel Days

Multicultural experience

Career Path

Mentoring / Learning Platforms

Discounts on appliances

Discounts at universities, language schools

Formación

• Bachelor’s degree in Industrial Engineering, Chemical Engineering, or a related field.
• Minimum of 2 years of experience in Project Management.
• Solid knowledge of Quality Systems, Mexican Regulations, ISO 9001.

Responsabilidades

• Lead and coordinate cross-functional areas for the launch of pharmaceuticals and medical devices.
• Promote compliance with regulations and ethical business practices.
• Drive the implementation of the Ethics and Compliance Program.

Conocimientos

Project Management

Fluency in Spanish

Fluency in English

Quality Systems Knowledge

Knowledge of Mexican Regulations

Educación

Bachelor’s degree in Industrial Engineering or related field

Herramientas

CorelDRAW

Microsoft Office

Microsoft Project

TrackWise 8

JDE

Descripción del empleo

Be a part of Stefanini!

At Stefanini we are more than 30,000 geniuses, connected from more than 40 countries, we co-create a better future.

¡Apply Launch & Regulatory Compliance Project Manager (Manufacturing & Healthcare). !

Requirements

• Bachelor’s degree in Industrial Engineering, Chemical Engineering, or a related field.
• Minimum of 2 years of experience in Project Management.
• Availability to work onsite three times per week at the Polanco / Masaryk office, Mexico City.
• Solid knowledge of Quality Systems, Mexican Regulations, ISO 9001, CorelDRAW, Microsoft Office, and Microsoft Project.
• Preferred experience with TrackWise 8, JDE, or other ERP systems.
• Fluency in both Spanish and English.

Essential Duties and Responsibilities

• Lead and coordinate cross-functional areas for the launch of pharmaceuticals, medical devices, and medical equipment within the Mexico Cluster.
• Promote a culture of compliance with regulations and ethical business practices across the organization.
• Drive the implementation of the Ethics and Compliance Program and prevent, detect, and correct violations of the law, Baxter policies, and the Code of Conduct.
• Implement Baxter’s Code of Conduct, policies, and procedures, including but not limited to the Global Interactions Policy and Third-Party Policy, supporting business processes and ensuring employee onboarding and training.
• Identify compliance and legal risks within the country / cluster.
• Develop implementation plans for each project (Gantt charts), involving the corresponding functional areas.
• Monitor the product launch process and coordinate with involved teams to ensure activities are completed according to agreed timelines, using Baxter’s established tools and processes.
• Apply corrective action plans when necessary to ensure launches meet established timelines.
• Document all new product launch projects in Baxter systems; when regulatory and / or quality aspects are impacted, utilize Change Control and / or FMEA tools to support implementation and commercialization.
• Create product code set-ups for finished goods and raw materials within Baxter systems such as JDE, SQLM, POMS, and TCU, as applicable.
• Design printed product materials in accordance with the current Registration conditions of the corresponding country.
• Generate specifications for printed materials to be received at the manufacturing site, ensuring part number creation and / or obsolescence management within TCU, JDE, SQLM, and POMS systems.
• Create Bills of Materials (BOMs), Product Control Specifications, and / or update SOPs to support receipt, packaging, and release at manufacturing plants and distribution within the Mexico Cluster countries.
• Ensure product designs comply with conditions approved by regulatory authorities and that final designs receive proper approval.
• Review labeling projects (artworks / labels) prior to submission to regulatory authorities.
• Provide support to Marketing Management during post-launch activities.
• Develop procedures for the Marketing area.
• Support global change control initiatives through GeoExpansion (GeoExp).
• Lead improvement and cost‑saving projects for the Marketing area.
• Ensure compliance with the annual training program for the Marketing department.
• Respond to and implement applicable corporate policies related to the process.

What’s in for you?

• Law Benefits + PTU
• Hybrid Job (CDMX)
• Company Equipment
• Attendance Bonus
• Punctual Bonus
• Food Vauchers
• Restaurant Vauchers
• Personnel Days
• Multicultural experience
• Path Career
• Mentoring / Learning Platforms
• Discounts on appliance
• Discounts at universities, language schools