Clinical Compliance Manager

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 outcomes for patients. And you’ll be developing yourself in a global environment with an inspirational culture, with lots of opportunities. All the while building a successful career, with real purpose.

Are you a seasoned clinical research professional with a passion for compliance and a knack for navigating complex regulations? Do you have a proven track record of ensuring adherence to research guidelines and driving quality in clinical evidence generation? If yes, we want to hear from you!

Mölnlycke is seeking a Clinical Compliance Manager to join our Clinical, Medical, and Professional Affairs (CMPA) organisation. This is an opportunity to work independently and at the same time be a part of a team in a fast-paced, dynamic environment.

In this position you will operate globally and stationed out of our headquarters in Gothenburg.

About the job

As the Clinical Compliance Manager at CMPA, you will play a pivotal role in ensuring adherence to regulatory requirements, standards, and company policies across all clinical generation activities. You will lead efforts to uphold best practices in clinical research and ensure full compliance with regulatory frameworks.

This position involves spearheading the development, implementation, and upkeep of robust clinical quality management systems and standard operating procedures. You will report to Senior Manager Clinical Compliance.

Key responsibilities include:

• Ensure that all clinical research activities comply with applicable regulations and standard
• Maintain, implement and update Clinical, Medical, and Professional Affairs (CMPA) Standard Operating Procedures (SOPs) to meet regulatory requirements
• Stay current on regulations and industry standards to ensure compliance and provide in-house expertise on clinical evidence generation, clinical data collection, and relevant healthcare compliance
• Define training needs and keep the department informed and trained on relevant rules, regulations, and guidelines
• Manage CMPA’s audit-related activities, including vendor qualification and clinical studies
• Responsible for managing and monitoring NC, CAPA, planned deviations, and other clinical quality-related activities at CMPA
• Liaise with internal and external parties involved in legal, quality, and regulatory affairs to anticipate and respond to new developments in clinical evidence generation
• Mentor and support other team members

What you will need:

• Academic background in Life Sciences (medical, clinical, regulatory, or scientific)
• Minimum 6 years of experience in Clinical Research within Medical Device/Pharmaceutical/CRO industries
• In-depth knowledge of clinical research rules, regulations, guidelines, and industry trends
• Experience with Non-Conformance, Corrective and Preventive Actions (CAPAs), planned deviation is a must
• Proficiency in Good Clinical Practice (GCP) principles (e.g., ISO 14155:2020, 21 CFR, EU MDR) and other relevant regulations/standards (e.g., GDPR, MDCG, MDSAP)
• Experience in developing, implementing and maintaining procedures
• Excellent networking skills, high ethical standards, and strong communication abilities with the capability to assert necessary compliance measures
• 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 experience
• Experience in Quality Affairs (QA)
• Clinical writing experience
• Certification in Quality management (e.g., CQA, CMQ/OE)

What you’ll get…

• Wellness benefits
• Flexible working hours
• Great colleagues in a global company
• An open, friendly and fair working atmosphere
• Competitive compensation package including company pension plan, bonus, company health care

Our approach to diversity and inclusion

At Molnlycke 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 the four business areas Wound Care, Operating Room Solutions, Gloves and Antiseptics, where customer centricity, sustainability and digitalisation are at the heart of everything we do.

Mölnlycke employs around 8,700 people. The company headquarters are in Gothenburg, Sweden and we operate in more than 100 countries worldwide. Mölnlycke is a founding partner of GoCo Health Innovation City, a world-class innovation cluster for health, and in early 2025 our headquarters will move there. Since 2007, the company has been part of Investor AB, an engaged owner of high-quality, global companies which was founded by the Wallenberg family in 1916.

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

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