Arbetsbeskrivning

If you’re ready to have an impact in a career that makes a difference, Mölnlycke could be your next step. You’ll be helping to equip medical professionals around the world with solutions to improve patient outcomes. You’ll also be developing yourself in a global environment with an inspirational culture and plenty of opportunities—all while building a successful career with real purpose.

Are you a seasoned clinical research professional with a passion for clinical compliance and process excellence? Do you have a proven track record of ensuring adherence to research regulations and driving quality in clinical evidence generation and dissemination? If so, we want to hear from you!

Mölnlycke is seeking a Clinical Compliance & Process Excellence Manager to join our Clinical, Medical, and Professional Affairs (CMPA) organization.

This is an opportunity to work independently—either at HQ or remotely—while also being part of a collaborative and dynamic global team.

About the job

As the Clinical Compliance & Process Excellence Manager, you will play a pivotal role in ensuring the organization maintains full compliance with all relevant regulations and standards. You will drive best practices and optimize processes for clinical evidence generation and dissemination, ensuring efficiency, accuracy, and compliance with evolving regulatory frameworks across Mölnlycke.

This role will support the Director of Clinical Compliance in ensuring regulatory adherence and process excellence.

Key Responsibilities include

• Review, develop, and implement CMPA policies, SOPs, work instructions (WIs), and forms within the QMS, collaborating with process owners as needed.
• Ensure all clinical data collection complies with relevant laws and regulations, including but not limited to ISO 14155: 2020, ICH/GCP, GDPR, MDSAP, EU MDR, HIPAA, and FDA regulations.
• Stay up to date on regulatory changes, industry trends, and evolving guidelines to ensure a compliant way of working within CMPA.
• Define training needs and ensure CMPA team members are well-informed and trained on relevant rules, regulations, and guidelines.
• Lead and manage CMPA’s audit-related activities, including vendor qualifications and clinical studies.
• Own audit-related activities within CMPA, including preparation, participation, execution, and follow-up.
• Oversee and manage non-conformance (NC), corrective and preventive actions (CAPAs), and planned deviations related to clinical quality.
• Liaise with internal and external stakeholders, including legal, quality, and regulatory affairs teams, to anticipate and respond to new developments in clinical evidence generation and healthcare compliance.
• Mentor and support team members in understanding and implementing regulatory and quality requirements.
• Drive clinical process optimization and efficiency while maintaining regulatory adherence.

What you will need:

• Academic background in Life Sciences (medical, clinical, regulatory, or scientific).
• Minimum 5 years of experience in Clinical Research within the Medical Device, Pharmaceutical, or CRO industry.
• In-depth knowledge of clinical research regulations, including ISO 14155, EU MDR, GDPR, HIPAA, FDA regulations, and MDSAP.
• Strong experience in developing and maintaining SOPs, policies, and procedures to ensure regulatory adherence.
• Experience with Non-Conformance (NC), CAPAs, planned deviations, and other clinical quality-related processes.
• Proven ability to interpret and translate regulatory requirements into actionable procedures.
• Strong communication, training, and mentoring skills to guide internal and external stakeholders on clinical compliance matters.
• Hands-on, results-driven approach with a proactive mindset, ready to tackle challenges, drive solutions, and make an impact.
• Able to balance strategy and operations while staying goal-focused and results-driven.
• Fluency in English (written and spoken).
• Ability to travel up to 25% domestically and internationally.

Preferred Qualifications

• Experience in Wound Care Management.
• Clinical Research Associate (CRA) or Study Monitor experience.
• Experience in Quality Affairs (QA).
• Certification in Quality Management (e.g., CQA, CMQ/OE).

What You’ll Get…

• Wellness benefits
• Flexible working hours
• Join a dynamic global team of talented professionals, collaborating to make a real impact.
• Experience a supportive, collaborative, and inclusive work environment.
• Competitive compensation package, including company pension plan, bonus, and healthcare coverage.

Our Approach to Diversity & Inclusion

At Mölnlycke, diversity is not just a vision—it’s our strength. We are dedicated to fostering an inclusive workplace that values and celebrates diversity. We believe that diversity fuels innovation, creativity, and problem-solving. We invite you to be part of a team where authenticity is embraced, and every employee, regardless of background, experiences a true sense of belonging. Your attitude, drive, enthusiasm, and eagerness to learn are just as important to us as your technical qualifications.

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 into 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 8,700 people and operates in more than 100 countries worldwide. Our headquarters are in Gothenburg, Sweden, GoCo Health Innovation City, a world-class innovation cluster for health. Since 2007, we have been part of Investor AB, a global company owned by the Wallenberg family.

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

If this sounds like you and you have what it takes to succeed in this role, we want to hear from you as soon as possible!