(Senior) Regulatory Affairs Manager (m/w/d) || Medical DevicesYour opportunity to shape the future of medical technology!Are you an experienced Regulatory Affairs professional with a passion for advancing medical device development? Do you want to contribute to the implementation of the MDR and global product approvals in an innovative company? Your Responsibilities:Maintain MDSAP and ISO 13485 certifications: You will ensure that our international certifications remain up to date and that all regulatory requirements are met.Implement MDR 2017/745: You will coordinate projects to ensure successful MDR implementation and support departments in complying with regulatory requirements.Drive the development of RA processes: You will develop, integrate, and monitor RA processes, ensuring continuous improvement.Support development projects: You will accompany development projects and take responsibility for creating and maintaining the technical documentation required for medical device approvals.Manage audits and inspections: You will support national and international audits and represent the company during quality inspections by notified bodies.Oversee international product approvals: You will manage product registrations in international markets (Europe, USA, Japan, Canada), from initiation through to successful completion. Your Profile:Degree in Medical Engineering, Medical Technology, or a related field.Professional experience in Regulatory Affairs in the medical device industry.Analytical thinking and can manage complex processes in a structured and methodical way.Organizational skills, flexibility, and a strong ability to work effectively in a team.Technical understanding and can clearly communicate complex technical details.Fluent English skills are essential, as you will be working with international stakeholders and authorities.Why You Should Join the Company:Career development opportunities: They offer a dynamic environment where you can actively shape your career, with opportunities for further training and involvement in exciting projects.Flexible work arrangements: flexible working hours and the possibility of remote work.Attractive compensation and benefits: competitive salary and a range of benefits About the Company: A leading company in the medical device sector, committed to revolutionizing healthcare with innovative solutions. They are looking for a dedicated Regulatory Affairs Specialist (m/f/d) who will not only manage regulatory compliance but also take responsibility for setting new industry standards.Ready for the next step? If you are excited about the opportunity to contribute to global medical device development, I'm looking forward to receiving your application! Tel: 089 26 20 09 25 E-Mail: M.Inderhees@sciproglobal.de

Regulatory Affairs Specialist (m/w/d) || Medical Devices || Your opportunity to shape the future of medical technology!Are you an experienced Regulatory Affairs professional with a passion for advancing medical device development? Do you want to contribute to the implementation of the MDR and global product approvals in an innovative company? Your Responsibilities:Maintain MDSAP and ISO 13485 certifications: You will ensure that our international certifications remain up to date and that all regulatory requirements are met.Implement MDR 2017/745: You will coordinate projects to ensure successful MDR implementation and support departments in complying with regulatory requirements.Drive the development of RA processes: You will develop, integrate, and monitor RA processes, ensuring continuous improvement.Support development projects: You will accompany development projects and take responsibility for creating and maintaining the technical documentation required for medical device approvals.Manage audits and inspections: You will support national and international audits and represent the company during quality inspections by notified bodies.Oversee international product approvals: You will manage product registrations in international markets (Europe, USA, Japan, Canada), from initiation through to successful completion. Your Profile:Degree in Medical Engineering, Medical Technology, or a related field.Professional experience in Regulatory Affairs in the medical device industry.Analytical thinking and can manage complex processes in a structured and methodical way.Organizational skills, flexibility, and a strong ability to work effectively in a team.Technical understanding and can clearly communicate complex technical details.Fluent English skills are essential, as you will be working with international stakeholders and authorities. Why You Should Join the Company:Career development opportunities: They offer a dynamic environment where you can actively shape your career, with opportunities for further training and involvement in exciting projects.Flexible work arrangements: flexible working hours and the possibility of remote work.Attractive compensation and benefits: competitive salary and a range of benefits About the Company: A leading company in the medical device sector, committed to revolutionizing healthcare with innovative solutions. They are looking for a dedicated Regulatory Affairs Specialist (m/f/d) who will not only manage regulatory compliance but also take responsibility for setting new industry standards. Ready for the next step? If you are excited about the opportunity to contribute to global medical device development, I'm looking forward to receiving your application! Tel: 089 26 20 09 25E-Mail: M.Inderhees@sciproglobal.de

Junior Regulatory Affairs Specialist (m/f/d) || Medical Technology || About the Company: The leading company in the field of medical technology develops and distributes innovative solutions that contribute globally to improving patient care. The team consists of experts who are passionate and dedicated to meeting the highest regulatory and quality standards. Join an international environment where your expertise is valued, and you can help shape the future of medical technology. Your Responsibilities:Creation and Maintenance of Regulatory Dossiers: You will develop, update, and maintain international regulatory dossiers for our products.Coordination of International Approvals: In collaboration with our country representatives, you will conduct approval processes for medical devices of all classifications.Regulatory Database Management: You will manage and update regulatory data in our database, ensuring a comprehensive overview of existing approvals.Consultation and Point of Contact: As the central contact, you will support our international partners, consultants, and authorities with all relevant questions and requirements.Regulatory Monitoring: You will continuously analyze and assess regulatory developments and requirements for our target markets.Document Preparation for Certifications and Legalizations: You will ensure all documents meet regulatory requirements and handle the certification and legalization processes. Your Profile:Qualifications: Degree in Medical Technology, Mechanical Engineering, Regulatory Affairs, or a comparable field.Professional Experience: At least 1-2 years of experience in Regulatory Affairs, ideally in the field of active medical devices.Knowledge: Familiarity with the IEC 60601-1 standard.Language Skills: Fluent in German and English, both written and spoken. What the Company Offers You:Flexible Working: Modern work models and the option to work remotely.Attractive Compensation Package: Performance-based salary and additional social benefits. Interested in applying or have questions? Please feel free to contact me directly at my phone number or via email: Tel: +49 89 26 20 09 25 Email: M.Inderhees@sciproglobal.de

Regulatory Affairs Specialist (m/w/d) || Medizintechnik || Über das Unternehmen: Das führende Unternehmen im Bereich der Medizintechnik entwickeln und vertreibt innovative Lösungen, die weltweit zur Verbesserung der Patientenversorgung beitragen. Das Team besteht aus Experten, die mit Leidenschaft und Engagement daran arbeiten, den höchsten regulatorischen und qualitativen Standards gerecht zu werden. Werden Sie Teil eines internationalen Umfelds, in dem Ihre Expertise geschätzt wird und Sie zur Gestaltung der Zukunft im Bereich Medizintechnik beitragen können. Ihre Aufgaben:Erstellung und Pflege von Zulassungsdossiers: Sie entwickeln, aktualisieren und pflegen internationale Zulassungsdossiers für unsere Produkte.Koordination internationaler Zulassungen: Gemeinsam mit unseren Ländervertretungen führen Sie Zulassungsverfahren für Medizinprodukte aller Klassifizierungen durch.Pflege der Zulassungsdatenbank: Sie verwalten und aktualisieren Zulassungsdaten in unserer Datenbank und behalten so stets den Überblick über bestehende Zulassungen.Beratung und Ansprechpartner: Als zentraler Ansprechpartner unterstützen Sie unsere internationalen Partner, Berater und Behörden in allen relevanten Fragen und Anforderungen.Regulatorische Überwachung: Sie analysieren und bewerten kontinuierlich regulatorische Entwicklungen und Anforderungen für unsere Zielmärkte.Dokumentenvorbereitung für Beglaubigungen und Legalisationen: Sie stellen sicher, dass alle Dokumente den behördlichen Anforderungen entsprechen und führen die Beglaubigungs- und Legalisationsprozesse durch. Ihr Profil:Qualifikation: Abgeschlossenes Studium in Medizintechnik, Maschinenbau, Regulatory Affairs oder einem vergleichbaren Studiengang.Berufserfahrung: Mindestens 3 Jahre Erfahrung im Bereich Regulatory Affairs, idealerweise im Bereich aktive Medizintechnik.Kenntnisse: Kenntnisse in der Norm IEC 60601-1Sprachkenntnisse: Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift Was bieten das Unternehmen Ihnen:Flexibles Arbeiten: Moderne Arbeitszeitmodelle und die Möglichkeit für Remote-Arbeit.Attraktives Vergütungspaket: Ein leistungsorientiertes Gehalt und zusätzliche Sozialleistungen.Sie möchten sich auf die Stelle bewerben oder haben Fragen dazu? Dann kontaktieren Sie mich gerne unter meiner direkten Durchwahl oder meiner E-Mail: Tel: 089 26 20 09 25E-Mail: M.Inderhees@sciproglobal.de

SciPro are currently working exclusively with a rare disease pharmaceutical company who are looking for an experienced Clinical Programmer to join their Clinical Operations team. The company is proud to be a patient-centric organisation looking to transform the global rare disease space by bringing innovative medicines to those suffering with rare and debilitating diseases.This role plays a pivotal part in supporting clinical and research projects of the company, working closely with cross functional stakeholders to lead on accurate data collection, analysis and reporting, ultimately supporting the advancement of medical knowledge and patient care.Key Responsibilities:Provide state-of-the-art programming to extract and integrate dataProject management of programming activities across multiple studies to increase the efficiency and output of reportingContributes to oversee and maintain the available data sources to ensure continued data integrity Key Requirements:Programming Languages - SAS, R, Python or SQLFamiliarity with CDISC standards, including SDTM and ADaMGood understanding of GCP, FDA, EMA guidelines