Regulatory Affairs Specialist
vor 4 Wochen
ADLINK Technology GmbH is a leading provider of embedded hardware and software solutions. We are part of the ADLINK Technology Group and have over 1,950 employees in Europe, USA, Taiwan, China, and Singapore. Our products are sold in more than 40 countries on 5 continents.
We are looking for a highly motivated Team member based in Deggendorf/Mannheim Germany to fill the role of Junior Manager Regulatory Affairs (f/m/x) for Electrical products for medical devices.
What we offer:- A long-term and permanent employment in an exciting international technology business environment.
- A competitive and attractive salary with a performance-based annual bonus.
- Opportunity for JobBike Leasing.
- Excellent working environment.
- International, intercultural, and collegial working environment.
- Preparation and updating of technical documentation in an international context (Class 1 MD).
- Preparation of risk management documents according to 60601.
- Creation of development documents.
- Creation of certification documents.
- Supervision of the certification process.
- Carrying out EMC/Safety preliminary measuring tests.
- Creation and maintenance of internal regulatory documents.
- Handling of international product registrations in Europe (MDR) as well as in other relevant markets.
- Risk Management according to ISO 14971: Risk management activities, including risk assessment, analysis, and mitigation strategies, to ensure safety and regulatory compliance.
- Participate in Post-Market Surveillance Activities: Post-market surveillance process, including, adverse event reporting, and vigilance activities, to ensure continuous product safety monitoring.
- Regulatory Compliance: Stay up to date with relevant regulations, directives, and standards (e.g., EU Medical Device Regulation, ISO and ensure the company's compliance with all applicable requirements.
- Experience (2 years) working in Regulatory Affairs role(s) within the medical device industry, preferably active medical devices and software acc. to EN 62304.
- Solid knowledge of applicable regulations and standards, such as EU MDR, ISO 13485, FDA regulations, etc.
- Understanding of risk management principles and methodologies.
- Communication skills, both written and verbal, with fluency in English and German.
- It is nice to have: Experience with CE marking and international regulatory submissions.
Do you feel like talking to us in more detail? Want to know more?
- What are you waiting for? Contact us NOW Please provide an English CV too
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