Global Regulatory Affairs Strategy Manager (m/f/d)
Responsibilities
- 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.
Profile
- Education: Bachelor or Master, in Regulatory Affairs, Life Sciences, Medical Industry, Information Technology, law or related fields
- 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
Benefits
- We will give you valuable tips and feedback on your application documents and interviews
- We will create a candidate profile containing your strengths and potential and thus increase your chance of being placed in a position
About Hays
Our many years of recruitment experience and our expert knowledge of the engineering job market make us a strong partner for engineers and technicians. We maintain close relationships with customers across all industries and therefore can provide engineering specialists with exciting projects and attractive job opportunities, drawing on your personal interests and experience. As your professional companion, we support you throughout the entire process, from the first contact to the first day on your new job – all this completely free of charge. Register now and look forward to many interesting and suitable positions and projects.
Hays steht für Vielfalt und setzt sich aktiv für Chancengerechtigkeit und Teilhabe ein. Alle - unabhängig von Geschlecht, sexueller Orientierung, Behinderung, Alter, Herkunft sowie kultureller und religiöser Zugehörigkeit - erhalten bei uns die gleichen Möglichkeiten. Daher laden wir alle Menschen, besonders auch Menschen mit Behinderungen dazu ein, sich bei uns zu bewerben.
Staffing process for a permanent or temporary position
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We will review your application documents and carry out a detailed analysis of your professional qualification.
Contact at Hays
+ 49 621 1788-4297 Bei Fragen zur Barrierefreiheit und Inklusion steht die folgende Anlaufstelle vertraulich zur Verfügung: inklusion-hpsg@hays.de.© Copyright Hays plc, . Das Wort HAYS, die H-Symbole, „Hays Working for your tomorrow" und „Powering the world of work" sowie damit verbundene Logos und Illustrationen sind eingetragene Markenzeichen der Hays PLC. Die H-Symbole sind Originaldesigns, die in vielen Ländern geschützt sind. Alle Rechte vorbehalten.