Regulatory Affairs Specialist: Strategic Medical Device Expert

5 days ago


Boulder, Colorado, United States Lifelancer Full time
About the Role

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Medtronic, a global leader in healthcare technology. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the success of our medical device products by providing strategic guidance on regulatory requirements and collaborating with cross-functional teams.

As a Regulatory Affairs Specialist, you will be responsible for preparing 510(k) submissions and technical documents to support CE mark and other international submissions. You will also participate in negotiations and interactions with regulatory authorities during the development and review process.

In this role, you will have the opportunity to work on a wide range of projects, from new technologies to product modifications, and develop your expertise in domestic and international regulations. Your strong working knowledge and experience with reviewing advertising and promotional materials for medical devices will be valuable assets in this position.

Responsibilities
  • Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering both domestic and international regulations.
  • Prepare 510(k) submissions and technical documents to support CE mark and other international submissions.
  • Participate in negotiations and interactions with regulatory authorities during the development and review process.
  • Review promotional and advertising material.
  • Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards.
Requirements

To be successful in this role, you will need:

  • Bachelor's degree with 4+ years of regulatory affairs experience in the medical device, biotech, or pharmaceutical industry.
  • OR an advanced degree with 2+ years of regulatory affairs experience in the medical device, biotech, or pharmaceutical industry.
  • Strong working knowledge and experience with reviewing advertising and promotional materials for medical devices.
  • Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams.
  • Ability to adapt to changing priorities and deadlines, with a strong attention to detail and organizational skills.
What We Offer

At Medtronic, we offer a competitive salary and benefits package, including a base salary range of $88,800 - $133,200 per year, depending on experience and qualifications.

We also offer a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off. Additionally, we provide opportunities for professional growth and development, including training and education programs.



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