Launch & Regulatory Compliance Project Lead (Manufacturing & Healthcare)

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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