Regulatory Affairs Manager

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 markets
• Monitoring 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 sales
• Handling of change and renewal procedures as well as upkeep of existing registrations
• Close 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)"?

• Degree in natural sciences, medicine, engineering, or technology, or equivalent qualifications.
• Relevant professional experience in the regulation of medical devices
• Comprehensive knowledge in Regulatory Affairs focusing on international product approvals
• Experience 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/year
• Home 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.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!