Ottobock

Regulatory Affairs Specialist – m/f/d

Ottobock

full-time

Posted on:

Location Type: Office

Location: Duderstadt • Germany

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About the role

  • Identify approval-relevant requirements for international markets and develop internal strategies to derive the necessary regulatory submission documents
  • Prepare and procure regulatory supporting documents (e.g., obtaining and legalizing certificates of free sale) in cooperation with international sales
  • Correspond with national and international regulatory authorities
  • Maintain and verify product-specific data in SAP for the conformity assessment process of medical devices
  • Provide ad-hoc support in implementing regulatory requirements within various development projects

Requirements

  • Degree in a technical or technical-business discipline such as mechatronics, electronics, or mechanical engineering
  • Ideally 1–2 years of professional experience in Regulatory Affairs at a medical device company or in another regulatory environment within the medical or pharmaceutical sector
  • Proficient with common MS Office applications; MS Access and SAP knowledge is an advantage
  • Independent, structured and analytical working style, with goal-oriented thinking and actions
  • Team player with strong communication skills, creativity, and flexibility
  • Very good written and spoken German and English
Benefits
  • Flexible and family-friendly working time models plus 30 days' vacation
  • Company pension plan and private accident insurance
  • Structured onboarding program for an optimal start
  • Corporate benefits, Wellpass membership, and discounts with local businesses
  • Staff lounge and health management offerings
  • Individual support and development through internal (Ottobock Academy) and external training measures
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory submission documentsconformity assessment processregulatory requirementsanalytical working stylegoal-oriented thinking
Soft Skills
independent workingstructured workingteam playerstrong communication skillscreativityflexibility