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Chief of Regulatory Compliance and Risk Management
vor 3 Monaten
About PAUL HARTMANN AG:
At PAUL HARTMANN AG, our mission is to support, protect, and enhance the quality of life for healthcare professionals and their patients. We are dedicated to creating innovative solutions that truly make a difference in the healthcare sector.
Position Overview:
We are seeking a qualified individual to join our team as the Head of Regulatory Affairs within the Risk Prevention division. This pivotal role involves being a key member of the Divisional Management Board, overseeing all regulatory obligations for our comprehensive product range, which encompasses medical devices, system and procedure packs, personal protective equipment, and various commodities.
Key Responsibilities:
- Ensure adherence to all regulatory standards and requirements across the entire product portfolio in all relevant markets.
- Assist the business division in crafting and executing regulatory strategies aligned with project frameworks and strategic initiatives.
- Lead and develop the Regulatory Affairs team, which consists of six dedicated professionals.
- Assess and establish the appropriate regulatory strategy for each product within the portfolio.
- Oversee and contribute to post-market surveillance, labeling, regulatory documentation, and conformity assessments.
- Engage in the drafting and evaluation of regulatory processes, ensuring alignment of resources and activities with commercial objectives.
- Support clinical, biological, risk management, usability, and standards management efforts for the division.
Qualifications:
- A university degree in life sciences, natural sciences, or a related field.
- A minimum of five years of relevant experience in a Regulatory Affairs capacity within an international organization.
- Certification as PRRC in accordance with MDR.
- In-depth knowledge of regulatory requirements pertaining to medical devices, including MDR, MDD, and related standards.
- Demonstrated experience in team leadership and development.
- Strong project management capabilities, particularly in managing international projects.
- Exceptional communication and collaboration skills, with a proven ability to work effectively with cross-functional teams at all levels.
- Fluency in both written and spoken English and German.
Benefits:
- Flexible working arrangements, including adaptable hours and remote work options.
- International mobility opportunities.
- Supportive measures for balancing work and family life, such as childcare subsidies.
- Company vehicle with private usage options.
- 30 days of paid leave annually, plus additional leave for significant life events.
- Attractive company pension plan with competitive employer contributions.
- Ample parking, on-site canteen, and employee shop offerings.
- Access to a wide range of fitness and wellness facilities.
- Various health and wellness initiatives, including screenings and online mental health courses.
- Job bike leasing options.
- Exclusive discounts on travel, fashion, and technology through our corporate benefits platform.
Join us in shaping a future focused on healthcare excellence, grounded in a culture of trust and collaboration.
