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- Aufgaben: Manage clinical evaluations and ensure compliance with medical device regulations.
- Arbeitgeber: Join HARTMANN, a global leader in healthcare innovation.
- Mitarbeitervorteile: Enjoy flexible hours, remote work, and 30 days paid leave annually.
- Warum dieser Job: Be part of a meaningful mission while developing your skills in a supportive environment.
- Gewünschte Qualifikationen: A degree in life sciences and experience in regulatory affairs are essential.
- Andere Informationen: Access to fitness facilities and attractive discounts on travel and tech.
Das voraussichtliche Gehalt liegt zwischen 48000 - 84000 € pro Jahr.
Job Description
Natural Scientist as Clinical Evaluation Manager (f/m/d) At HARTMANN, you have the opportunity to become part of a global team. As a Manager Regulatory Affairs Clinical (f/m/d), we offer you a varied and challenging position in an international environment. Here, you can develop your skills and play an active role in ensuring the proper execution of procedures demonstrating medical device compliance with relevant clinical performance and safety requirements.
If you are also enthusiastic about our meaningful product portfolio, we should get to know each other. Responsibilities: * Provide and update documentation of clinical evaluation, post-market clinical follow-up and post-marketing surveillance * Cross-functional communication with other departments such as Marketing and R&D to ensure required input documentation is up to date * Coordinate external service providers to support clinical evaluation documentation, PMCF and PMS * Determine clinical evidence requirements according to MDR and relevant MDCGs * Identify equivalence to existing devices, if required, in accordance with MDRs and relevant MDCGs. * Conduct literature searches and reviews in according to MDR/MEDDEV 2.7.1 rev. 4 * Provide searches in relevant vigilance databases * Support for risk analysis and study planning for CE and PMCF studies Qualification: * University degree in life science/natural science or an equivalent qualification * Professional experience in the medical device environment or another regulatory field of work * Knowledge in regulatory requirements, MDR and relevant MDCGs, rel. MEDDEVs * Experience in literature search and review required as well as knowledge of regulatory medical writing * Knowledge of database management * Open and competent attitude when working with your stakeholders * IT affinity and proficiency with the MS Office package * Fluent written and spoken English Benefits: * Flexible working conditions, such as flexible working hours and mobile working * International Mobile Working * Attractive ways of combining work and family life, e.g.
childcare subsidy * 30 days paid leave per year, plus special leave for exceptional life events as well as vacation pay and special annual payment according to collective agreement * Company pension plan with attractive employer contribution incl. matching model for deferred compensation * Plenty of parking spaces, canteen with café bar and ongoing offers in the employee shop * Access to over 6000 fitness and yoga studios, swimming pools as well as Crossfit and bouldering halls (EGYM Wellpass) * Various health and fitness offers, e.g. skin cancer screenings, online courses for mental health, massage offers, yoga during lunch break etc. * Job Bike Leasing * Attractive discounts on e.g.
travel, fashion and technology via our corporate benefits platform
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Natural Scientist as Clinical Evaluation Manager (f/m/d) Arbeitgeber: ZipRecruiter
Kontaktperson:
ZipRecruiter HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Natural Scientist as Clinical Evaluation Manager (f/m/d)
✨Tip Number 1
Familiarize yourself with the latest updates on the Medical Device Regulation (MDR) and relevant MDCGs. This knowledge will not only help you understand the requirements better but also demonstrate your commitment to staying current in the field.
✨Tip Number 2
Network with professionals in the medical device industry, especially those involved in clinical evaluations. Attend relevant conferences or webinars to connect with potential colleagues and learn about best practices in the field.
✨Tip Number 3
Showcase your experience with literature searches and reviews by discussing specific projects or studies you've worked on. Highlighting your analytical skills can set you apart from other candidates.
✨Tip Number 4
Prepare to discuss your cross-functional communication skills during the interview. Be ready to provide examples of how you've successfully collaborated with different departments, as this is crucial for the role.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Natural Scientist as Clinical Evaluation Manager (f/m/d)
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Clinical Evaluation Manager position at HARTMANN. Understand the responsibilities and qualifications required, and think about how your experience aligns with these.
Tailor Your CV: Customize your CV to highlight relevant experience in regulatory affairs, clinical evaluation, and medical writing. Use keywords from the job description to ensure your application stands out.
Craft a Compelling Cover Letter: Write a cover letter that expresses your enthusiasm for the role and the company. Mention specific experiences that demonstrate your ability to meet the job requirements, such as your knowledge of MDR and literature review skills.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for the role.
Wie du dich auf ein Vorstellungsgespräch bei ZipRecruiter vorbereitest
✨Understand the Regulatory Landscape
Make sure you have a solid grasp of the Medical Device Regulation (MDR) and relevant MDCGs. Be prepared to discuss how these regulations impact clinical evaluations and post-market surveillance.
✨Showcase Your Cross-Functional Communication Skills
Since the role involves collaboration with various departments like Marketing and R&D, be ready to provide examples of how you've effectively communicated and coordinated with different teams in your previous roles.
✨Demonstrate Your Research Abilities
Prepare to discuss your experience with literature searches and reviews. Highlight specific instances where your research contributed to successful clinical evaluations or regulatory submissions.
✨Express Enthusiasm for the Product Portfolio
Show genuine interest in HARTMANN's product offerings. Familiarize yourself with their portfolio and be ready to discuss how your background aligns with their mission and values.
