Regulatory Affairs Manager (m/w/d) für MedizinprodukteFür den Süddeutschen Standort sucht mein Kunde eine/n Regulatory Affairs Manager(m/w/d). In dieser Rolle sind Sie für die Recherche, Bewertung und Implementierung regulatorischer und normativer Anforderungen verantwortlich und tragen maßgeblich zur Sicherstellung der Qualität und Compliance von Produkten bei. Ihre Aufgaben:Recherche, Bewertung und Implementierung von regulatorischen und normativen Anforderungen für MedizinprodukteDurchführung von GAP-Analysen sowie Erstellung und Aktualisierung von technischen Dokumentationen, Risikoanalysen und anderen relevanten DokumentenRecherche der Zulassungsvoraussetzungen und Durchführung nationaler sowie internationaler Zulassungs-, Verlängerungs- und ÄnderungsverfahrenKommunikation mit Behörden und Distributoren im Rahmen von ZulassungsverfahrenPflege des Post-Market-Surveillance-Systems zur Sicherstellung der Produktqualität im MarktUnterstützung bei weiteren Themen im Bereich Qualitätsmanagement Ihr Profil:Abgeschlossenes Studium im Bereich Ingenieurwesen, Naturwissenschaften oder einer vergleichbaren FachrichtungBerufserfahrung im Bereich Regulatory Affairs, idealerweise im MedizinproduktebereichSehr gute Kenntnisse der relevanten regulatorischen Anforderungen und NormenErfahrung in der Erstellung technischer Dokumentationen sowie in der Durchführung von ZulassungsverfahrenAusgezeichnete Kommunikationsfähigkeiten in Deutsch und Englisch Bereit für den nächsten Schritt?Wenn Sie sich auf die Möglichkeit freuen, zur globalen Entwicklung von Medizinprodukten beizutragen, freue ich mich auf Ihre Bewerbung!Tel: 089 26 20 09 25E-Mail: M.Inderhees@sciproglobal.de

Global HEOR LeadLocation: Remote SciPro have partnered with a well established, global pharmaceutical company who are preparing for their next product and growing within their primary and acute care business unit. We are supporting their search for a Global HEOR Lead to spearhead the health economics and outcomes research (HEOR) strategy for a groundbreaking lipid-lowering therapy with a novel mechanism of action. This role will be pivotal in shaping the commercial launch of the asset internationally, with a focus on major EMEA markets. You will lead HEOR activities, drive data generation, and leverage clinical trial readouts to support market access and reimbursement strategies.This role is an exciting opportunity to make a meaningful impact on a new therapy, offering innovative solutions for patients.Key ResponsibilitiesHEOR Launch Leadership: Manage HEOR strategies for the product launch, ensuring data supports access and adoption across diverse international markets.Data Generation & Trial Insights: Interpret and utilize clinical trial outcomes to generate actionable insights for market access strategies.Cross-Functional Collaboration: Work closely with global and regional teams in market access, medical affairs, and commercial functions to ensure cohesive strategies.Matrix Leadership: Operate within a lean global team, while coordinating cross-functional activities.Strategic Vision: Support the current product launch and prepare for future portfolio innovations across primary and acute care therapies.Key RequirementsExperience: At least 10 years of HEOR experience, including significant exposure to international or regional leadership roles.Therapy Expertise: Demonstrated background in lipid-lowering therapies or cardiovascular areas, ideally with recent product launches.Leadership & Autonomy: Self-motivated and capable of driving projects with minimal supervision in a remote, matrixed environment.Collaboration: Strong communicator and team player, comfortable forming and managing relationships online and in-person across global teams.Technical Knowledge: Deep understanding of HTA processes and market access strategies in complex healthcare systems.Apply Now to become a key player in this exciting journey!

Business Development Manager (North, UK) SciPro are pleased to be working with a market leader in endoscopy who is experiencing a surge in inbound demand-hospitals and surgeons are actively seeking them out. With cutting-edge technology and a renowned training academy, they are setting new industry standards. They have already seen huge success across the EU and are now expanding in the UK. We are seeking a Business Development Manager (BDM) to join as the second pivotal hire in the UK to support expansion in the Midlands and North. Role Overview & Responsibilities:Expand sales and drive revenue across the North of the UK with autonomy in decision-making.Build and maintain relationships with hospitals, theatre managers, and NHS stakeholders.Collaborate with internal teams to implement strategies, ensure smooth order processing, and support customer needs.Manage end to end sales cycle and take ownership of lead generation, workshops, and hospital visits.Open new accounts and refine the sales process to convert prospects into committed customers.Meet with customers in person to build relationships and expand market presence across your region.Ideal Candidate Profile:Results-driven and self-motivated with a hunter mentality and a strong commitment to opening new accounts and expanding market presence.Energetic and open-minded, with the potential to grow into a leadership role as the region develops.Willing to learn the business processes and policies, playing a key role in supporting the UK's growth.Capable of managing long sales cycles with patience, persistence, and strategic thinking to drive success.Compensation & Benefits:Competitive base salary + commission and bonusCompany car allowanceA rare opportunity to have significant autonomy, shape the UK market, build a team and be involved in one of the most exciting growth areas in medtech right now!Work remotely with customer travel If you're interested in finding out more, click apply!

SciPro is working with an exciting and rapidly growing UK/EU based Pharma company looking to expand in the US. Role Overview: This position involves developing specialty distribution strategies for neurology products, managing distributor relationships, ensuring compliance, and optimizing supply chain efficiency. Key responsibilities include overseeing contracts, performance metrics, and customer compliance, while collaborating across teams to drive improvements in distribution efficiency.This Role would be preferrably Hybrid at the Boston office 1 day a week minimum, but can be remote preferrably on the east coast. Must Haves:Bachelor's degree (Business, Healthcare Administration, or related field); Master's preferred3-6 years of pharmaceutical industry experience, with 3+ years in specialty distributionExpertise in 340B specialty distribution and regulatory complianceProven experience managing specialty distributor relationshipsStrong knowledge of pharmaceutical distribution models, pricing strategies, and contract negotiation Preferred:Specialty pharmacy and distribution in the neurology marketsProficiency in data analytics tools (Excel, Power BI, Tableau, etc.).Advanced analytical skills, with experience in performance metrics and continuous improvementStrong leadership and cross-functional collaboration abilities