Regulatory Affairs Manager (m/w/d)
Negotiable
Baden-Württemberg

Regulatory Affairs Manager (m/w/d) für Medizinprodukte

Für 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 Medizinprodukte
  • Durchführung von GAP-Analysen sowie Erstellung und Aktualisierung von technischen Dokumentationen, Risikoanalysen und anderen relevanten Dokumenten
  • Recherche der Zulassungsvoraussetzungen und Durchführung nationaler sowie internationaler Zulassungs-, Verlängerungs- und Änderungsverfahren
  • Kommunikation mit Behörden und Distributoren im Rahmen von Zulassungsverfahren
  • Pflege des Post-Market-Surveillance-Systems zur Sicherstellung der Produktqualität im Markt
  • Unterstützung bei weiteren Themen im Bereich Qualitätsmanagement

Ihr Profil:

  • Abgeschlossenes Studium im Bereich Ingenieurwesen, Naturwissenschaften oder einer vergleichbaren Fachrichtung
  • Berufserfahrung im Bereich Regulatory Affairs, idealerweise im Medizinproduktebereich
  • Sehr gute Kenntnisse der relevanten regulatorischen Anforderungen und Normen
  • Erfahrung in der Erstellung technischer Dokumentationen sowie in der Durchführung von Zulassungsverfahren
  • Ausgezeichnete 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 25

E-Mail: M.Inderhees@sciproglobal.de

Apply
Other roles you might
be interested in:
Vice President, Strategy & Scientific Excellence (Precision Medicine)
New York

SciPro Global is retained on an executive search for a leading global biomedical company looking for a Vice President, Strategy & Scientific Excellence. They are building the most advanced cloud computing platform to realize the promise of precision medicine. The team and products enable scientists to analyze petabyte-scale molecular and health data faster and more efficiently than ever to identify new therapeutic targets, improve diagnostics and accelerate understanding of the basic underpinnings of health and disease. They are a global company with roughly 300 employees. This is a fully remote position. This role reports into the Chief Scientific Officer, and you will play a critical role in setting the long-term vision and direction of their products and ensure scientific rigor is deeply integrated throughout their products. As the VP, you will manage two functions within the organization: 1. Strategy Management (responsible for long term strategy roadmap) and 2. Scientific Center of Excellence (responsible for SME scientific motivated demonstrations of their products). Therefore, prior experience managing a team and demonstrated leadership skills are necessary to be successful in this role as a key responsibility will be to onboard and hire several staff in the next 12 months. Additional skills required: Experience implementing strategies at scale and have scientific expertise to be effective in this roleAdvanced degree (PhD/ MD / MBA) and/or 10+ years experience in relevant scientific fieldDemonstrated experience recruiting, training, retaining and maximizing the productivity of high functioning technical teams during times of organizational growth8+ years proven experience ideating, iterating and executing significant corporate strategies leading to accelerated revenue growth and innovationProven track record of leading end-to-end product initiativesAbility to manage uncertainty, demonstrate good judgment and incorporate data into decisions This is an exciting opportunity to change the course of precision medicine and make a dramatic impact to leading companies focusing on helping patients, by advancing their science much faster. You will be incorporating scientific expertise and leading cutting-edge findings in both public and private sectors and identify data systems which address interesting and hard problems that weren't even considered in the industry 5 years ago. If you're interested in learning more about this exciting opportunity, please apply with an updated CV and we will be in touch!

Senior Director, Payer Marketing & Pricing
Boston, Massachusetts

Senior Director, Payer Marketing, Pricing & OperationsA clinical-stage biotech company developing innovative therapies for serious eye diseases is seeking a Senior Director, Payer Marketing & Pricing to lead market access strategy.Key Responsibilities:Develop and implement payer strategy, value propositions, and pricing approaches.Oversee payer account messaging, marketing strategies, and budget management.Collaborate cross-functionally to drive patient access, contracting, and reimbursement.Lead and mentor the Payer Marketing team, ensuring strategic alignment with brand objectives.Establish pricing committee, ensure compliance, and support gross-to-net calculations.Manage payer marketing budget and trade-related congress presence.Develop materials for field reimbursement teams and specialty pharmacy networks.Analyze and optimize market access tactics to achieve business goals.Qualifications:Bachelor's degree required; advanced degree preferred.6+ years of pharmaceutical/biotech experience in market access, marketing, or pricing.Proven leadership in payer strategy across payers, providers, and health systems.Strong understanding of specialty pharmacy, reimbursement, and healthcare regulations.Experience in vendor management and contract negotiations.Preferred: Background in rare diseases and/or ophthalmology.Key Traits for Success:Entrepreneurial mindset with a hands-on, results-driven approach.Strong analytical, problem-solving, and communication skills.Ability to navigate a fast-paced, cross-functional environment.High ethical standards and professionalism.This is an opportunity to shape market access strategy for an innovative therapy addressing a high unmet need.

Executive Director, Real-World Evidence & Epidemiology
Philadelphia, Pennsylvania

SciPro is leading an Executive search for an Executive Director, Epidemiology & RWE for a Pharma company in Delaware. They are recognized across the globe for their consistency and ongoing clinical trials in dozens of disease areas and a robust portfolio of treatments. They have 7 approved products in the market and ongoing clinical trials in dozens of disease areas, with a focus in Oncology and Autoimmune. The Global Epidemiology group is responsible for leading and planning outcomes research and RWE activities for pipeline and in-line molecules including the design and implementation of retrospective database studies, assessment of PROs, and conduct of epidemiological studies. This role reports into the EVP of Global Product Strategy and you will spearhead the Global Epi and RWE function of the organization. You will manage a group of 11 individuals, with plans to continue growing the team and will be successful in this role with the following experience: Advanced degree in relevant field (i.e. Epidemiology, Outcomes Research, Biostatistics, etc.)10+ leadership responsibilities and demonstrated ability to manage a relatively larger group i.e. the group this person will be managing are 4 in Global Epi (Senior Director, 3 Associate Directors), 3 in RWE Biostats (Senior Director, Director and Associate Director), and 5 in RWE Programming (Associate Director, Senior Manager and 3 contractor)Direct interactions with regulatory bodies (FDA, EMA) and ability to lead discussions around Epidemiology, Clinical Outcomes, Patient Outcomes, new tool development, etc.Extensive RWE Generation experience, preferably in Oncology for AutoimmuneUnderstanding of both US and ex-US healthcare and pharmaceutical industry and different data sources.Demonstrated research accomplishment (e.g. publications in peer-reviewed journals, presentations at scientific conferences) expected.Excellent oral and written communication skills and ability to work well independently as well as across organizational teams.

Sr./ Director, Business Development (Real-World Evidence)
Boston, Massachusetts

SciPro is retained with a healthcare data and technology company focused on real world clinical data and outcomes, accelerating medical research and personalizing healthcare. They leverage big data, standardized outcomes measurement, and AI technology, and have built the first intelligent data cloud for healthcare, enabling more precise information and better decision making for stakeholders across the healthcare ecosystem. They pride themselves on having big data, and also having big goals on how to quickly, accurately and cost-effectively deliver more powerful real-world evidence and registries to meet emerging needs. Role: Sr./ Director, Business Development - you will utilize your network and background in real world evidence generation and real-world study design and planning to create valuable business relationships and generate new bookings for the business. The hiring manager (Vice President, Business Development) is looking for someone to work in tangent with the RWE and Epidemiology team to develop sales and go-to-market strategies and tactical plans for target markets and customers. The "musts":10+ years of experience of direct, consultative sales in life sciencesBusiness development experience in industry (CRO, healthcare tech/analytics, healthcare vendor, etc.) in an RWE settingExperience selling prospective trials or RWE studiesStrong knowledge of the clinical development process and where RWE fits within the puzzle of the life cycleFamiliarity with RWD (EMRs, EHRs, claims, etc.), retrospective data and prospective data collectionPrevious success selling prospective data (ideally 10M annual sales minimum)Established network in RWE The "nice to haves":Rare Disease therapeutic area experienceManagement/leadership experience

ML/DL Staff Scientist
Boston, Massachusetts

SciPro is recruiting for a HealthTech Computational Platform company backed by a leading VC company looking to expand their Machine Learning Data Science team. The company is VC backed and has received over 400mm in funding (over 3 rounds) and has made 2 successful acquisitions. They are recognized for trying to treat drug discovery and development like a loop where each project they have can generate data that informs projects to follow. They are doing this through ML algorithms and patient data, creating the first closed loop platform that will give insights into every step of the discovery and development process. Their platform is positioned to advance therapeutic candidates in half of the time for half the cost and have higher rates of success across the board. You will be successful in this role with the following qualifications and experience: PhD in a quantitative field with 3+ years of post-degree experienceBroad experience in ML including random forest, logistic regression, dimensionality reduction, clustering, metrics, model selection, feature selection, and explainability (3+ years required).Demonstrated experience implementing and applying deep learning approaches such as representation learning, sequence models, transformers, and self-supervised learning on high dimensional or multimodal data (2+ years required).Proficient in Python (3+ years required) and experience with ML, deep learning, and data science packages.Experience with ML on raw EHRs (electronic health records): Minimum 1 year of experience required.Experience with large-scale data analytics engines (e.g., Spark or Dask) and working in cloud environments (e.g., AWS).Experience with statistical methods such as hypothesis testing, longitudinal modeling, and time to event analysis.Excellent communication skills and ability to work in a cross-functional environment. This role will join the Data Science team where you will be responsible for exploring and proposing the adoption of cutting-edge technologies, such as transformer models, to enhance the efficiency and effectiveness of deep learning approaches applied to EHR data. The role entails conducting independent research, and this involves identifying relevant research findings and adapting them to address project needs. This is an individual contributor role. This is a fully remote opportunity offering industry competitive compensation and an opportunity to join a team of industry leading scientists in this space. At this time, the business cannot offer any visa sponsorship. Please apply if you're interested in learning more.

banner

Need more help? Reach out<br></br> to one of our team.

We are a trusted partner for every step from Discovery through to Development. So, no matter where you are in your journey, we're here to help you make a difference. We are a trusted partner for every step from Discovery through to Development. So, no matter where you are in your journey, we're here to help you make a difference.