We develop, produce and market implants for the treatment of spinal diseases in an international environment. These implant systems are tailored precisely to the needs of spine surgeons, clinical staff and patients.
Regulatory Affairs Manager 100% w|m|d
- Support in the implementation of regulatory road map and associated strategy
- Creation and review of documents, as part of the technical documentation, in accordance with the legal requirements of the various jurisdictions (e.g. EU-MDR, FDA, ANVISA, TGA, etc.)
- Filing and maintaining marketing authorisations in EMEA, USA, South America and ASIA-PAC including country registrations
- Participate in risk management activities and assess materials for bio-compatibility
- Support in the introduction of new standards and regulations and maintenance of all QM documents regarding regulatory aspects and requirements, in consultation with the Head of Quality
- Support with audits and inspections (e.g. ISO 13485, FDA 21 CFR 820) as well as clinical evaluation of products and market surveillance (PMS)
- At least 3-4 years of experience in regulatory affairs in the life sciences sector, preferably in the medical devices sector
- Bachelor's degree in engineering or natural sciences, regulatory affairs or another technically related field
- Demonstrated skills in planning, administering and approving CE registrations and US 510(k) approvals, including effective communication with the US FDA, European Notified Bodies, Competent Authorities and other regulatory authorities.
- Experience with other legal areas (APAC, LATAM) is an advantage
- Detailed knowledge of medical device standards and processes such as ISO 13485, ISO 14971, 93/42/EEC & EU 2017/745, MDSAP, PMS, Vigilance.
- Experience working with cross-functional teams and providing regulatory input
- Proactive and flexible personality with strong data analysis and technical writing skills, as well as project management and communication, striving to get things done in a diverse environment
- Fluent in German and English (oral/written)