Specialist Regulatory Affairs.

Job ID: 11151

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Regulatory Affairs
Type of employment
  • Coordinate, prepare and review worldwide regulatory submissions to authorities and / or Notified Body
  • Compile and maintain regulatory documentation
  • Prepare regulatory summarizing documents to record compliance efforts
  • Interface with domestic and international authorities and Notified Body
  • Prepare and review Post-Market-Surveillance Evaluations and coordinate the underlying regulatory projects
  • Review Clinical Evaluations for regulatory compliance
  • Collaborate in the risk-management activities
  • Monitor impact of changes in applicable standards and regulations and provide support to design and implement strategies to maintain compliance
  • Ensure continuous compliance by identifying gaps and coordinate remediation management of regulatory processes and tasks
  • Support in the redesign of regulatory related processes and documents to improve the level of compliance including advisory on SOPs
  • Provide ongoing support to internal parties for regulatory related issues
  • Advise on regulatory related issues to product development teams to facilitate a timely market access
  • Lead regulatory projects
  • Several years of professional experience in Regulatory Affairs
  • Graduate preferably in technical or natural scientific studies or academic degree with equivalent experience in international submissions and/ or regulatory compliance.
  • Proficient knowledge of medical device related standards, directives and regulations such as ISO 13485, ISO 14971, MDD, MPG requirements
  • Profound knowledge of international regulatory pathways and requirements, e.g. CE Marking, and Technical Files and
  • Experience in handling with domestic and international authorities and Notified Bodies
  • Team player with ability to work with diverse collaborators
  • Excellent and effective written and verbal communication skills
  • Excellent interpersonal skills, good judgment and analytical skills
  • Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision
  • Must be able to manage multiple tasks and perform with accuracy and a high attention to detail
  • Effective time management and organizational skills
  • Consistent, quality work and follows through on commitments
  • Decision making and problem solving abilities
  • Social competency
  • Fluency at least in written and spoken German and English