Clinical Compliance Manager

Essity, a global leader in hygiene and health, seeks a Clinical Compliance Manager. Drive compliance and innovation in a supportive, resource-rich environment. With significant autonomy and opportunities for international collaboration, this role offers a unique chance to shape impactful projects and advance your career.

Essity – a leading global hygiene and health company and the home of brands like TENA, Libresse, Cutimed, Sorbact and JOBST is offering an exciting and challenging opportunity for you who want to contribute with your expertise, energy and creativity. We are looking for an additional colleague to join our company as a Clinical Compliance Manager, a newly established role in the department of Global Clinical Affairs, within Global Marketing & Innovation(GMI) Global Unit.

As Clinical Compliance Manager, you will be responsible for ensuring that all aspects of our clinical studies are conducted in compliance with regulatory, legal, and quality standards. This includes overseeing the entire quality system, from study planning and execution to reporting, and staying updated on applicable rules, regulations, and industry standards. You will actively participate in, and perform, audits and inspections. This senior role requires a proactive approach to maintaining compliance and implementing improvements in our way of working.

This is a hybrid role (>50% in the office) that can be based at our office in Gothenburg or Hamburg.

• Accountable for a regulatory, legal, and quality-compliant structure of processes, procedures, instructions, and templates.
• Actively stay updated on applicable rules, regulations, industry standards, and guidelines.
• Represent the company in applicable forums, such as industry working groups.
• Implement improvements in the way of working.
• Define training needs and keep the organization informed and trained as needed.
• Build and maintain a broad network of internal and external experts.
• Act as the subject matter expert in internal and external discussions and meetings, such as audits, vendor meetings, and site audits.
• Manage and monitor nonconformities, corrective and preventive actions, deviations, and other quality-related activities.
• Mentor and support other team members.
• You may also manage clinical projects.

You are a seasoned professional with a deep understanding of clinical research regulations and industry standards. You are proficient in regulatory frameworks such as ISO-14155, EU MDR, 21 CFR, GDPR, and MDCG, and have experience managing non-conformities, CAPAs, and deviations. You possess high ethical standards, strong communication and networking skills, and the ability to mentor and support team members and local/global key stakeholders. Your proactive approach and ability to stay on top of industry changes make you an invaluable asset to our team.

• Relevant academic background (preferably MSc or higher).
• In-depth knowledge of clinical research rules, regulations, guidelines, and industry standards.
• Experience with non-conformance, CAPAs, and deviation management.
• Proficiency in applicable regulatory frameworks (e.g., ISO-14155, EU MDR, 21 CFR, GDPR, MDCG).
• Proven track record of developing, implementing, and maintaining pragmatic and easy to work with procedures and way of working.
• High ethical standards and strong communication and networking skills.
• Knowledge of the Clinical Evaluation processes is beneficial.

Interested? If you are up for the challenge and think this sounds like you, apply online today! Kindly note that due to GDPR we cannot accept applications via mail. CV (and possible cover letter) should be in English.

We may conduct background checks in the final stages of the recruitment process to verify your qualifications and fit for the role.

Our purpose, Breaking Barriers to Well-being, provides meaning to everything we do. Working at Essity means a chance to improve well-being for people and opportunities to drive positive change for the society and the environment. As an employee at Essity, you will belong to an organization where you feel valued and supported to grow and challenged to generate business results in a collaborative and open atmosphere.

Innovate for Good | Excel Together | Be You with Us

Application End Date: 21 apr. 2025

Job Requisition ID: Essity252194