Senior Regulatory Affairs Specialist Medical Device

STRATASYS

On-site
Medical device regulatory compliance
Fda submission experience
Additive manufacturing knowledge
Stratasys is seeking a Senior Regulatory Affairs Specialist for its medical device division, focusing on ensuring compliance with regulatory standards in the 3D printing industry. The ideal candidate should have significant experience in regulatory processes, particularly in medical devices, and a strong understanding of relevant compliance protocols

Job Summary

  • The role involves ensuring medical device products comply with global regulatory standards and FDA requirements.
  • Candidates will support the company's mission to transform patient care through innovative 3D printing solutions.
  • This position requires managing the regulatory strategy for additive manufacturing technologies across healthcare industries.

Matching Summary

Match Score: 85

Stratasys is seeking a Senior Regulatory Affairs Specialist for its medical device division, focusing on ensuring compliance with regulatory standards in the 3D printing industry. The ideal candidate should have significant experience in regulatory processes, particularly in medical devices, and a strong understanding of relevant compliance protocols.

Skills & Requirements

Must-have

  • Medical device regulatory compliance
  • FDA submission experience
  • Additive manufacturing knowledge

Nice-to-have

  • Strategic product lifecycle management
  • Cross-functional team collaboration
  • Global market expansion support

Key Requirements

  • Senior level experience in Regulatory Affairs
  • Bachelor's degree or equivalent in related field
  • Proven track record in medical device submissions

Work Rights

Not specified

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