Advanced Ivd Regulatory Affairs Specialist - Oem Products

Bio-Techne Corporation

Base: $62,300.00 - $102,350.00; bonus/equity: not ...
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Bachelor's degree with 2-4 years experience
Knowledge of global ivd regulations
Experience with medical device compliance
** Bio-Techne Corporation is seeking an Advanced IVD Regulatory Affairs Specialist to manage regulatory submission activities and ensure compliance with medical device regulations. The ideal candidate should have a Bachelor’s degree with 2-4 years or a Master’s degree with up to 3 years of relevant experience in regulatory affairs. **

Job Summary

  • The role involves ensuring compliance with applicable medical device regulations per jurisdiction and guidance.
  • Employees are offered competitive insurance benefits starting on day one including medical, dental, vision, and life insurance.
  • The position requires collaborating with product development, operations, and legal departments to prepare regulatory submissions.

Matching Summary

Match Score: 75

** Bio-Techne Corporation is seeking an Advanced IVD Regulatory Affairs Specialist to manage regulatory submission activities and ensure compliance with medical device regulations. The ideal candidate should have a Bachelor’s degree with 2-4 years or a Master’s degree with up to 3 years of relevant experience in regulatory affairs. **

Salary

Base: $62,300.00 - $102,350.00; Bonus/Equity: Not specified; Benefits: Medical, dental, vision, life, 401k, ESPP

Skills & Requirements

Must-have

  • Bachelor's degree with 2-4 years experience
  • Knowledge of global IVD regulations
  • Experience with medical device compliance

Nice-to-have

  • Excellent verbal and written communication skills
  • Ability to work in fast-paced environment
  • Strong problem-solving and root cause analysis skills

Key Requirements

  • Bachelor's degree required
  • 2-4 years relevant experience
  • Master's degree with up to 3 years experience

Work Rights

Not specified

Tailored Resume

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