About the Role:

We are seeking a highly skilled and experienced professional to lead our Regulatory Affairs team within the Risk Prevention division at PAUL HARTMANN AG. As the Head of Regulatory Affairs, you will be responsible for ensuring compliance with all regulatory requirements of our entire product portfolio in all relevant markets.

Key Responsibilities:

• Develop and implement regulatory strategies to ensure compliance with relevant standards and legal requirements.
• Lead the Regulatory Affairs team, comprising six members, and provide guidance on regulatory matters.
• Evaluate and define the proper regulatory strategy approach for each product.
• Manage and coordinate post-market surveillance, labeling, regulatory product documentation, and conformity assessments.
• Contribute to the writing and reviewing of regulatory processes.
• Collaborate with cross-functional stakeholders to ensure regulatory compliance.

Requirements:

• A University degree in life science, natural science, or an equivalent qualification.
• At least 5 years of relevant professional experience in a Regulatory Affairs role within an international company.
• Qualification as PRRC according to MDR.
• Comprehensive knowledge of regulatory requirements for medical devices, personal protective equipment, and in-vitro diagnostics.
• Proven experience in leading and developing a team.
• Strong project management skills, with a preference for experience in managing international projects.
• Excellent communication and collaboration skills.
• Fluent written and spoken English and German.

What We Offer:

• Flexible working conditions, including flexible working hours and mobile working.
• International mobile working.
• Attractive ways of combining work and family life.
• Company vehicle with private usage.
• 30 days paid leave per year, plus special leave for exceptional life events.
• Company pension plan with attractive employer contribution.
• Access to fitness and yoga studios, swimming pools, and other health and fitness offers.
• Job bike leasing.
• Attractive discounts on travel, fashion, and technology.