RA Manager Infection Control

Job title: RA Manager Infection Control

About the Role Join Getinge's Infection Control team to help ensure our products meet global regulatory requirements and support safe patient care. As RA Manager Infection Control, you will lead regulatory affairs activities across Infection Control sites, providing strategic direction, ensuring compliance, and driving cross-site collaboration in a highly regulated MedTech environment.

What You'll Do

• Develop and implement regulatory strategies to ensure products comply with applicable regulations and standards.
• Lead and support regulatory submissions and approvals, including CE marking, 510(k), and other market authorizations.
• Act as primary contact for notified bodies during technical documentation assessments and regulatory reviews.
• Review and approve technical files, regulatory documentation, labeling, packaging, and product claims.
• Drive regulatory intelligence activities, provide training, manage regulatory risks, and support audits, inspections, and non-compliance investigations.

What We're Looking For

• Bachelor’s or master’s degree in quality management, Life Science, Industrial Technology, or related field.
• At least 3 years of experience in Regulatory Affairs or a related function within a regulated industry.
• Previous leadership experience (minimum 1 year) with the ability to lead projects and cross-functional teams.
• Strong knowledge of regulatory compliance, risk assessment, gap analysis, and compliance auditing.
• Experience working with regulatory databases and advanced Microsoft Office skills.
• Experience supporting internal and external audits.
• Ability to build relationships, influence stakeholders, and lead regulatory initiatives across multiple functions and locations.
• Passion for continuous learning and staying up to date with evolving regulatory requirements in MedTech.
• Proactive, self-driven attitude.

Nice to Have

• Meritorious knowledge of regulatory frameworks and standards such as ISO 13485, ISO 14971, MDR, MDD, MDSAP, ISO 14001.
• Location preference: Sweden; open to remote/hybrid work arrangement.

Compensation & Benefits

• Competitive compensation and benefits package, including wellness allowances, generous family benefits and joint company activities.