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- Aufgaben: Lead international product registrations and ensure compliance with regulatory requirements.
- Arbeitgeber: Join a dynamic company in the Medical Equipment Manufacturing industry, focused on innovation.
- Mitarbeitervorteile: Enjoy a full-time role with opportunities for professional growth and development.
- Warum dieser Job: Make an impact by ensuring product safety and compliance in a fast-paced environment.
- Gewünschte Qualifikationen: Must have relevant studies or experience, plus knowledge of regulatory standards and procedures.
- Andere Informationen: Ideal for those passionate about medical and IT products with a keen eye for detail.
Das voraussichtliche Gehalt liegt zwischen 48000 - 84000 € pro Jahr.
The company is seeking a Regulatory Affairs Manager.
Responsibilities
- Responsibility for researching requirements, as well as planning, implementing, coordinating and monitoring international registrations of our products (Medical + IT)
- Implementation of the applicable regulatory requirements of the target markets in the company
- Continuous monitoring of changes in the regulatory requirements applied in the target markets
- Compilation of the necessary documents in cooperation with specialist departments, timely submission of documents to authorities for new registration and extensions
- Central contact for regulatory-relevant matters of international authorities or approval partners, as well as for internal company departments
- Testing and evaluation of product conformity (medical devices, IT products) with regard to regulatory (FDA, MDR, TGA…), technical requirements (GPSR, EMC, LV…) and environmental requirements (RoHS, REACH, POP, battery, packaging, return…), as well as release of product files
- Testing and evaluation of product changes relevant to approval
- Creation and updating of process descriptions and templates in the work area
- Post-market research and surveillance on relevant databases
Profile
- Completed studies (technical, medical, scientific) or comparable training and experience
- Additional qualification as Regulatory Affairs Manager
- Knowledge of DIN ISO 13485, ISO 9001, ISO 14001, ISO 27001
- Sound expertise in the national and international approval of medical and IT products (including MDR, FDA, TGA, ANVISA, SFDA, CQC…), experience in conformity assessment procedures, very good knowledge of the relevant product standards (IEC14971, IEC 60601, IEC 62368, IEC 62304, IEC 81001-5-1…)
Seniority level
- Mid-Senior level
Employment type
- Full-time
Job function
- Other
Industries
- Medical Equipment Manufacturing
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Regulatory Affairs Manager Arbeitgeber: EPM Scientific
Kontaktperson:
EPM Scientific HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Regulatory Affairs Manager
✨Tip Number 1
Familiarize yourself with the specific regulatory frameworks relevant to our products, such as MDR and FDA regulations. This knowledge will not only help you in interviews but also demonstrate your commitment to understanding the role.
✨Tip Number 2
Network with professionals in the regulatory affairs field, especially those who have experience with medical devices and IT products. Engaging with industry experts can provide insights and potentially lead to referrals.
✨Tip Number 3
Stay updated on the latest changes in regulatory requirements by following relevant publications and attending webinars. Showing that you are proactive about continuous learning can set you apart from other candidates.
✨Tip Number 4
Prepare to discuss specific examples of how you've successfully navigated regulatory challenges in past roles. Concrete examples will illustrate your expertise and problem-solving skills during the interview process.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Regulatory Affairs Manager
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly understand the responsibilities and requirements of the Regulatory Affairs Manager position. Highlight your relevant experience in researching regulatory requirements and managing international registrations.
Tailor Your CV: Customize your CV to emphasize your qualifications related to regulatory affairs, including any specific knowledge of DIN ISO standards and experience with medical and IT products. Use keywords from the job description to make your application stand out.
Craft a Strong Cover Letter: Write a compelling cover letter that showcases your expertise in regulatory affairs. Discuss your experience with compliance, product conformity testing, and your ability to monitor changes in regulations. Make it clear why you are a great fit for this role.
Highlight Relevant Achievements: In your application, include specific examples of past achievements in regulatory affairs, such as successful product registrations or improvements in compliance processes. Quantify your successes where possible to demonstrate your impact.
Wie du dich auf ein Vorstellungsgespräch bei EPM Scientific vorbereitest
✨Show Your Regulatory Knowledge
Make sure to highlight your understanding of regulatory frameworks like MDR, FDA, and TGA. Be prepared to discuss how you've navigated these regulations in past roles.
✨Demonstrate Cross-Department Collaboration
Since the role involves working with various departments, share examples of how you've successfully collaborated with teams to compile necessary documents and meet regulatory requirements.
✨Stay Updated on Regulatory Changes
Discuss how you keep yourself informed about changes in regulatory requirements. Mention any specific resources or strategies you use to stay ahead in this fast-evolving field.
✨Prepare for Technical Questions
Expect questions related to product conformity and technical standards. Brush up on relevant standards like ISO 13485 and IEC 60601, and be ready to explain how you've applied them in your work.
