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 dossiers
• Development of strategies for regulatory assessments and submissions
• Gathering and analysis of regulatory intelligence
• Management of informational lists and databases
• Monitoring changes in regulatory requirements
• Coordination with internal departments and external partners
• Ensuring compliance with legal and regulatory frameworks
• Preparation of reports and documentation for authorities
• Maintaining relationships with regulatory authorities
• Supporting product market approvals
• Identifying regulatory risks and opportunities
• Monitoring 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 publications
• Capability to accurately and formally present and formulate scientific results and findings in both English and German
• Proficient in German and English, both spoken and written
• Formularbeginn

What does the company offer you?

• Contract type: Permanent full-time contract.
• Vacation: 30 days/year
• Home 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 structure
• Opportunities to quickly take on responsibility and make a meaningful impact
• Start date: As soon as possible

My contact details:

• Email: m.inderhees@sciproglobal.de
• Tel: 0049 (0) 89/26 20 09 25 (direct dial)
• Xing: https://www.xing.com/profile/Marlene_Inderhees/cv
• LinkedIn: 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!