Global Regulatory Affairs Manager
vor 4 Wochen
- In this position, you will serve as a regulatory expert and point of contact for business units, regions, and international partners regarding the global approval management of our product range.
- You will be accountable for managing the necessary documentation for approvals, particularly focusing on countries outside the European Union / EFTA.
- Your role involves coordinating approval activities with your global colleagues and distribution partners.
- Additionally, you will oversee and monitor the approval process from application to the receipt of authorization.
- As a member of the global Regulatory Affairs team, you will share best practices and engage in close professional collaboration.
- A successfully completed degree in a scientific or technical field or equivalent.
- You possess initial experience in the field of Regulatory Affairs within the medical devices sector.
- Ideally, you have knowledge or experience in global approval processes for medical products.
- Familiarity with regulatory requirements for medical devices, such as Regulation (EU) 2017/745 and ISO13485.
- A passion for working in an international team environment.
- Fluency in English is required, and good knowledge of German is advantageous.
- Flexible working conditions, including flexible hours and remote work options.
- International mobile working opportunities.
- Work-life balance support, such as childcare subsidies.
- 30 days of vacation per year, special leave for significant life events, vacation pay, and contractual annual bonuses.
- Company pension scheme with attractive employer contributions and support for salary conversion.
- Ample parking, a cafeteria with a café bar, and ongoing offers in the employee shop.
- Access to over 6000 fitness and yoga studios, swimming pools, as well as CrossFit and bouldering facilities (EGYM Wellpass).
- Various health initiatives, including skin cancer screenings, online mental health courses, massage services, and yoga during lunch breaks.
- JobRad leasing options.
- Attractive employee discounts on travel, fashion, and technology through our corporate benefits platform.
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