Regulatory Affairs Manager (m/f/x)
Negotiable
Medical Technology
Karlsruhe, Baden-Württemberg
Permanent
Hybrid

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)"?

  • Completed 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!

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