Inserat online seit: 14 April
Aufgaben der Stelle
Unser Angebot:
Attraktive Vergütung nach Tarifvertrag in Entgeltgruppe 9.Festanstellung im Rahmen der Arbeitnehmerüberlassung in Vollzeit mit 35 Stunden pro Woche.Sie arbeiten in einem spannenden Umfeld am Standort Aalen.Ihre Orizon Pluspunkte
Ihre Aufgaben:
Support the development of global regulatory strategies for new or changing business initiatives, taking into account international requirements (e.g. FDA, MDR, IVDR, NMPA, PMDA). Collaborate with external partners and stakeholders to ensure that new business initiatives meet all regulatory requirements in different markets. Adapt regulatory strategies to support strategic decisions and respond to changes in the regulatory environment. Identify regulatory opportunities and risks and derive measures to optimize market approval and product lifecycles. Evaluate and interpret regulatory requirements in different markets to support the development of innovative solutions and create competitive advantage. Provide advice to internal teams (e.g. R&D, Clinical, Quality, Marketing, SSC, Regulatory Operations) to support regulatory strategies. Communication with regulatory authorities (e.g. FDA, EMA, BfArM, notified bodies) to gain clarity on regulatory requirements. Monitoring of regulatory trends and changes, deriving adaptation strategies and helping to shape regulatory developments in relevant committees. Supporting due diligence processes and regulatory assessments as part of M&A projects. Organizes trainings for internal teams to anticipate regulatory requirements and design efficient processes.Ihr Profil:
Education: Bachelor or Master, in Regulatory Affairs, Life Sciences, Medical Industry, Information Technology, law or related fields Experience: 3+ years of experience in Regulatory Affairs within the Life Sciences or Medical industry, with a strong understanding of local, regional, and international regulatory requirements. Knowledge: In-depth knowledge of international regulatory requirements (e.g. FDA, MDR, ISO 13485, MDSAP, etc.) and experience in developing proactive regulatory strategies and interacting with authorities. Portfolio management: Experience in managing several parallel projects across geographies and functional areas. Skills: Communication, negotiation, collaboration and stakeholder engagement.Strategic thinking with analytical skills and strong problem-solving skills Ability to structure complex projects and drive change management.Personal drive and resilience to achieve successful outcomes. Languages: Proficiency in English; additional languages are an advantage.Ihr Partner:
Die Orizon Gruppe ist mit über 50 Standorten einer der führenden Personaldienstleister in Deutschland und Teil des internationalen Konzerns BREXA Holdings Inc. Wir bieten Personallösungen von der klassischen Arbeitnehmerüberlassung bis zu spezialisierten Recruiting- und Outsourcing-Dienstleistungen. Unsere Tochtergesellschaften OTTO Work Force Deutschland GmbH und die jobs in time medical GmbH ergänzen das Portfolio mit Fokus auf EU-Recruiting beziehungsweise medizinisches Fachpersonal.
Ihr Partner:
Wir gehören zu den
Top-15
Personaldienstleistern
Wir haben über
90
Niederlassungen
Mehr als
6.200
Mitarbeitende
