Regulatory Affairs Specialist - Cardiac Surgery

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Full Remote
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Offer summary

Qualifications:

Bachelor's degree in life sciences or related field., Experience in regulatory affairs, particularly in medical devices or cardiac surgery., Strong understanding of FDA regulations and ISO standards., Excellent communication and analytical skills..

Key responsibilities:

  • Prepare and submit regulatory documents to FDA and other regulatory bodies.
  • Collaborate with cross-functional teams to ensure compliance with regulations.
  • Monitor changes in regulations and assess their impact on products.
  • Provide guidance on regulatory requirements during product development.

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Medtronic XLarge http://www.medtronic.com
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