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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 of 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 medical devices or regulatory fields are required.
- Andere Informationen: Access to fitness facilities and discounts on travel and tech products.
Das voraussichtliche Gehalt liegt zwischen 48000 - 84000 € pro Jahr.
Job Description
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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Life Scientist as Clinical Evaluation Manager (f/m/d) Arbeitgeber: ZipRecruiter
Kontaktperson:
ZipRecruiter HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Life 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 regulatory affairs. Engaging in discussions or attending relevant conferences can provide insights and connections that may be beneficial during the application process.
✨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 and attention to detail can set you apart from other candidates.
✨Tip Number 4
Prepare to discuss your cross-functional communication skills. Be ready to share examples of how you've successfully collaborated with different departments, as this role requires effective coordination with Marketing and R&D teams.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Life 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 life sciences, regulatory affairs, and medical device environments. Emphasize your knowledge of MDR and MDCGs, as well as any experience with clinical evaluations and literature reviews.
Craft a Compelling Cover Letter: Write a cover letter that showcases your enthusiasm for HARTMANN's product portfolio and your ability to contribute to their global team. Mention specific experiences that demonstrate your skills in cross-functional communication and documentation management.
Highlight Soft Skills: In your application, emphasize your open and competent attitude when working with stakeholders. Mention your IT affinity and proficiency with MS Office, as these are important 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 Skills
Highlight your experience in collaborating with different departments like Marketing and R&D. Provide examples of how you've successfully coordinated with external service providers to support clinical evaluation documentation.
✨Demonstrate Your Research Abilities
Be ready to talk about your experience with literature searches and reviews. Discuss specific methodologies you've used and how they contributed to clinical evidence requirements.
✨Communicate Your IT Proficiency
Since database management and MS Office proficiency are key, be prepared to discuss your technical skills. Share examples of how you've utilized these tools in previous roles to enhance your work efficiency.
