Regulatory Affairs Manager - Medical Devices (m/f/x) | BAWÜ / hybrid Our client is a medium-sized medical technology company that ensures both the best possible and particularly gentle patient care, and also provides complete systems to enable surgeons to work safely and cost-effectively. What are your responsibilities as a " Regulatory Affairs Manager (m/f/x)"? Creation and maintenance of necessary documentation for the approval of medical devices in international marketsMonitoring of international regulatory requirements and market-specific registration demands.Implementation of regulatory requirements in coordination with internal process owners from R&D, product management, and salesHandling of change and renewal procedures as well as upkeep of existing registrationsClose communication with external entities and authorities worldwide, along with continuous development and enhancement of processes.What requirements should you bring as a " Regulatory Affairs Manager (m/f/x)"?Completed degree in natural sciences, medicine, engineering, or technology, or equivalent qualifications.Relevant professional experience in the regulation of medical devicesComprehensive knowledge in Regulatory Affairs focusing on international product approvalsExperience working within a quality management system and familiarity with European and international medical device regulations, ordinances, directives, and standards.Proficient in both German and English. What does the company offer you? Contract type: Permanent full-time contract.Vacation: 30 days/yearHome office: Up to 40% remote/mobile.Working hours: 40 hours/week.Access: On-site parking and excellent public transportation connections.Start date: As soon as possible. My contact details: Email: m.inderhees@sciproglobal.deTel: 0049 (0) 89/26 20 09 25 (direct dial)Xing: https://www.xing.com/profile/Marlene_Inderhees/cvLinkedIn: https://www.linkedin.com/in/marlene-inderhees-376a7a16b/ Are you interested in this position? Then you should apply now! If you desire additional or alternative job opportunities, I also welcome your application. I look forward to receiving your application!

Specialist Regulatory Affairs - Medical Devices (m/f/x) | hybrid The company has established a leading position in the fields of implant. They create solutions to bring the sounds of life, laughter and loved ones with hearing loss. In the coming years, the innovative company plans to introduce significant new developments. What are your responsibilities as a " Specialist Regulatory Affairs (m/f/x)"?Compilation and submission of regulatory dossiersDevelopment of strategies for regulatory assessments and submissionsGathering and analysis of regulatory intelligenceManagement of informational lists and databasesMonitoring changes in regulatory requirementsCoordination with internal departments and external partnersEnsuring compliance with legal and regulatory frameworksPreparation of reports and documentation for authoritiesMaintaining relationships with regulatory authoritiesSupporting product market approvalsIdentifying regulatory risks and opportunitiesMonitoring regulatory trends and developments What requirements should you bring as a " Specialist Regulatory Affairs (m/f/x)"?Completed degree in natural sciences, medicine, engineering, or technology, or equivalent qualifications.At least two years of professional experience in the international registration of medical devices (Class I to III)Ability to review, interpret, and evaluate medical and scientific data and publicationsCapability to accurately and formally present and formulate scientific results and findings in both English and GermanProficient in German and English, both spoken and writtenFormularbeginn What does the company offer you?Contract type: Permanent full-time contract.Vacation: 30 days/yearHome office: Up to 40% remote/mobile.Working hours: 40 hours/week.Access: On-site parking and excellent public transportation connections.A dynamic work environment with a flat organizational structureOpportunities to quickly take on responsibility and make a meaningful impactStart date: As soon as possible My contact details:Email: m.inderhees@sciproglobal.deTel: 0049 (0) 89/26 20 09 25 (direct dial)Xing: https://www.xing.com/profile/Marlene_Inderhees/cvLinkedIn: https://www.linkedin.com/in/marlene-inderhees-376a7a16b/ Are you interested in this position? Then you should apply now! If you desire additional or alternative job opportunities, I also welcome your application. I look forward to receiving your application!