Manager Regulatory Affairs (MedTech)

TL;DR

Manager Regulatory Affairs (MedTech): Leading regulatory activities for Infection Control products to ensure global compliance and market authorization with an accent on strategic direction and cross-functional collaboration. Focus on managing CE marking, 510(k) submissions, and ensuring technical documentation accuracy within a highly regulated environment.

Location: Preferred location is Sweden (Vaxjo); open to remote and/or hybrid working arrangements for the right candidate.

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows across intensive care, cardiovascular procedures, and sterile reprocessing.

What you will do

• Develop and implement regulatory strategies to ensure products comply with global regulations and standards.
• Lead and support regulatory submissions and approvals, including CE marking and 510(k) submissions.
• Act as the primary point of contact for notified bodies during technical documentation assessments.
• Review and approve technical files, labeling, packaging, and product claims.
• Drive regulatory intelligence activities, manage regulatory risks, and support audits and inspections.

Requirements

• Bachelor’s or master’s degree in quality management, Life Science, Industrial Technology, or a related field.
• At least 3 years of experience in Regulatory Affairs within a regulated industry.
• Minimum 1 year of leadership experience leading 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.
• Preferred residency or work authorization for Sweden.

Nice to have

• Knowledge of regulatory frameworks such as ISO 13485, ISO 14971, MDR, MDD, MDSAP, and ISO 14001.

Culture & Benefits

• Safe and informal work environment emphasizing close team collaboration and open dialogue.
• Structured plans for personal and professional learning and competence development.
• Competitive compensation package including wellness allowances and generous family benefits.
• Supportive culture for well-being and goal achievement through joint company activities.