Vacant job

Job Description

The UDI and Data Management Specialist will manage and make tactical and operational decisions related to our UDI system, QMS documentation, training, and other product data management tasks.

• Manage UDI and other data management-related projects and activities.
• Ensure that all activities to assure compliance with UDI regulations are fulfilled, particularly regarding the publication of data to authorities.
• Ensure solid communication within Mölnlycke regarding product master data, including an overview of interfaces to other systems using data (PIM, RR, etc.).
• Provide guidance to our global organization regarding UDI and other master data submissions (e.g., EHS, Sustainability data).

To succeed in this role:

• Good written and oral communication skills.
• Strong analytical skills.
• Good knowledge of product data structures and modeling.
• Decision-making capabilities.
• Proactive and customer-centric.
• Agile and result-oriented.

Interviews are conducted on an ongoing basis, so please submit your application today.

Responsibilities

The UDI and Data Management Specialist is accountable for:

• The global UDI process at Mölnlycke, ensuring that required data is published to authorities in due time and supporting commercial initiatives for data publication.
• Initiating and monitoring the CRUD matrix for product master data.
• Securing business requirements to enable fail-safe data transfer integrations between PLM, ERP systems, and integrated systems.
• Organizing and participating in stakeholder and governance meetings for UDI.
• Engaging in relevant dialogue with UDI suppliers.
• Developing and hosting necessary training for UDI and master data-related topics.
• Taking stakeholder perspectives into consideration.
• Developing required QMS documentation within UDI.
• Providing data management information via the Hub – introduction for newcomers, e.g., explanation of data management and system landscape.
• Making tactical and operational decisions on the global UDI roadmap.
• Making decisions focused on improving processes and practices regarding UDI and product data management.

Qualifications

• Minimum 5 years of experience in a relevant business area.
• Minimum bachelor’s degree in engineering or Life Sciences, or equivalent business experience.
• Experience working with PLM, UDI, ERP systems, and managing product master data.
• Knowledge of design control related to medical devices (e.g., ISO 13485 / CFR part 820) is an advantage.
• Understanding of GDSN, authority databases (e.g., GUDID, EUDAMED), and the relevant healthcare/medical device industry is an advantage.

About the Company

Randstad

At Randstad, we know that everyone has a place in the labor market. With operations throughout the country and across all competency areas, we help people find a job that feels right, where they have the opportunity to grow, develop, and reach their full potential.

With nearly 600,000 employees in 38 countries, Randstad is the world leader in HR services, with the goal of becoming the world's best and most appreciated partner in the labor market. By combining our passion for people with the power of today's technology, we help people and companies achieve their full potential. We call it Human Forward.