Quality & Regulatory Project Manager

Help us make breakthrough innovations in healthcare!

Do you want a career that impacts millions of people for the good? At Mölnlycke, you’ll be helping to equip medical professionals with solutions to improve outcomes for patients. And you’ll develop your career in a growing organization with an inspirational culture – where you’ll be recognized for the results you’ve achieved.

The Quality Assurance (QA) department orchestrates One Mölnlycke to provide our customers with world-leading medical solutions by assuring Quality and Compliance efficiently throughout the life cycle of our products. We aspire to make Quality an instinctive choice for everyone, every day at Mölnlycke. QA interacts closely with the different business areas and global functions to ensure required quality support and compliance for New Product Development, Life Cycle Management, Operations, and Commercial activities.

About the job

As a Quality & Regulatory Project Manager, you will be responsible for managing complex projects and stakeholder groups, coordinating activities within Quality and Regulatory teams, and delivering projects through strategic planning, execution, and closure. You will represent the quality and regulatory functions and drive related topics in key project meetings.

Key Responsibilities

• Organize and coordinate projects using proper project management tools.
• Use data to generate information to steer projects and provide evidence of improvements.
• Create and manage Quality and Regulatory plans, timelines, and responsibility matrices in alignment with process owners through cross-functional discussions.
• Ensure overall project plans align with QA/RA timelines provided by process owners.
• Plan, track, and monitor project activities with QA/RA process owners to maintain targeted submission dates.
• Partner with stakeholders to prioritize and execute projects appropriately.
• Identify problems, forecast risks, and proactively seek resolutions.
• Communicate effectively about projects and activities at different organizational levels.
• Provide guidance to Quality and Regulatory teams on uploading submission documents to the PLM system.
• Lead improvement activities, establishing repeatable and efficient processes adjusted to business needs.
• As a process owner, ensure effective and compliant execution of quality system processes, including nonconformance, CAPAs, complaints, and change controls. Constantly evaluate the suitability of the QMS to applicable quality and regulatory standards.

What you'll need

• 5+ years of experience in the medical device industry within Quality and/or Regulatory departments.
• 10+ years of project and change management experience.
• Working knowledge of Technical Documentation.
• Excellent organizational and management skills.
• Excellent written and oral communication skills, capable of delivering key communication with clarity and impact.
• Strong presentation skills.
• Excellent interpersonal and negotiation skills, with the ability to build networks and secure appropriate support and outcomes for projects.
• A constant focus on improving performance and excellence in all tasks.
• Problem-solving skills.
• Fluency in English, both written and spoken.
• Bachelor's degree in Sciences.

What you'll get

• Flexible working hours and a hybrid work-from-home policy.
• An attractive package including an annual bonus, pension, health insurance, and other benefits.
• Great opportunities to grow and develop within your role and in the organization.
• A great network of talents and colleagues at a diverse global company with an open, friendly, and fair working atmosphere.
• The opportunity to make a positive impact on the healthcare sector by contributing to digital solutions for customers and healthcare professionals.

Our approach to diversity and inclusion

At Mölnlycke, diversity is not just a vision, but our strength. We are dedicated to fostering an inclusive workplace that values and celebrates the power of diversity. At the heart of our commitment is the belief that diversity fuels innovation, creativity, and problem-solving. We invite you to be a part of a team where authenticity is embraced, and every employee, regardless of background or any other traits, experiences a true sense of belonging. Your attitude, drive, enthusiasm, and eagerness to learn are just as important to us as the requirements for the role.

About Mölnlycke

Mölnlycke is a world-leading medical products and solutions company that equips healthcare professionals to achieve the best patient, clinical, and economic outcomes. Our business is organized in four areas: Wound Care, Operating Room Solutions, Gloves, and Antiseptics, with customer centricity, sustainability, and digitalization at the heart of everything we do.

Mölnlycke employs around 8,400 people. The company headquarters are in Gothenburg, Sweden, and we operate in more than 100 countries worldwide. Since 2007, the company has been part of Investor AB, an engaged owner of high-quality global companies founded by the Wallenberg family in 1916.

For more information, please visit www.molnlycke.com and www.molnlycke.com/careers.