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Regulatory Affairs Senior Principal Specialist

2 months ago

Mounds View, Minnesota, United States AVC Medtronic Int'l Trading, Inc Full time

Regulatory Affairs Senior Principal Specialist at AVC Medtronic Int'l Trading, Inc. offers an opportunity to embark on a fulfilling career path dedicated to healthcare innovation and accessibility.

In this pivotal role, you will take the lead in overcoming obstacles to advancement in a more integrated and empathetic healthcare landscape.

Key Responsibilities:

As a Senior Principal Regulatory Affairs Specialist, your primary focus will be on crafting comprehensive strategies for global regulatory approvals, facilitating the introduction of new medical products, and ensuring compliance for existing offerings. Your expertise will be crucial in:

  • Formulating regulatory strategies and overseeing submission processes for complex product developments and maintenance of approved products.
  • Collaborating with Regulatory Affairs Specialists and international teams to provide regulatory guidance for new innovations and modifications to current products.
  • Engaging with engineers and technical experts to address potential regulatory challenges and inquiries from governing bodies.
  • Preparing and reviewing regulatory submissions (e.g., FDA, Notified Body) to secure timely approvals, while negotiating submission matters with agency representatives.
  • Supporting marketed products by reviewing labeling, promotional materials, and documentation for changes requiring regulatory consent.
  • Interacting with regulatory agencies at various levels to ensure compliance and address significant issues with managerial oversight.
  • Maintaining a thorough understanding of global regulatory standards and fostering positive relationships with agency personnel.
  • Providing essential business and product information to international regulatory teams to aid in strategy development.
  • Offering ongoing support to product development teams regarding regulatory queries and issues.
  • Ensuring adherence to quality policies and procedures to maintain high standards of work.
  • Mentoring junior Regulatory Affairs Specialists as directed.

Qualifications:

To be considered for this role, candidates should possess:

  • A Bachelor’s degree in a relevant field.
  • A minimum of 10 years of experience in regulatory affairs within the medical device sector, or 8 years with an advanced degree.

Preferred Qualifications:

Ideal candidates will have:

  • An advanced degree in a scientific discipline.
  • Experience with regulatory submissions in the US and EU.
  • Strong interpersonal skills and the ability to work effectively in teams.
  • Experience with cardiac devices or therapies.
  • Project management capabilities and excellent communication skills.

About AVC Medtronic Int'l Trading, Inc:

We are committed to leading the charge in global healthcare technology, tackling the most pressing health challenges with innovative solutions. Our mission is to alleviate pain, restore health, and extend life, uniting a diverse team of dedicated professionals.

At AVC Medtronic, we value our employees and recognize their contributions to our success, offering a competitive salary and a comprehensive benefits package designed to support your career and personal growth.