Sr. Regulatory Affairs Specialist (Medical Device)

Lead Regulatory Submissions & Drive Compliance for Cutting-Edge Medical Devices!

The Ranger Group has an exciting Contract-to-Hire opportunity for a Regulatory Specialist with one of our top-tier Medical Device clients in the Minneapolis/St. Paul area. This role begins on a contract basis, with the goal of converting to a full-time position.

If you're an experienced regulatory professional looking to lead high-impact submissions, collaborate with cross-functional teams, and ensure the successful approval of life-changing medical technologies, this is the perfect opportunity for you!
Why This Role?

* Own the regulatory process - lead submission strategies and approvals.
* Work with groundbreaking Class III medical devices, including implantable technologies.
* Be the expert - provide strategic guidance on FDA, EU MDR, and global regulations.
* Shape the future of compliance - develop and implement regulatory strategies.
* Collaborate with top innovators in the medical device industry.
Your Impact & Responsibilities:

As a Regulatory Specialist, you will play a crucial role in ensuring regulatory compliance and market success for innovative medical devices. You will:

* Lead regulatory submission projects for FDA (IDE, PMA, 510(k)) and EU MDR approvals.
* Develop and execute regulatory strategies to ensure the earliest possible market entry.
* Provide expert guidance to cross-functional teams on regulatory requirements.
* Interpret and implement company-wide regulatory policies and procedures.
* Author and submit regulatory documents, including 5-Day Notices, 30-Day Notices, Real-Time Reviews, 180-Day Supplements, and Annual Reports.
* Stay ahead of FDA guidance documents, CFR regulations, and EU MDR requirements.
* Oversee labeling, advertising, promotional materials, and regulatory compliance activities.
* Review and support manufacturing operations and change control processes.
What You Bring to the Team:

Experience & Expertise:

• 5 years in the medical device industry, with 5 years in FDA & EU MDR submissions for Class III devices.
  
• Proven experience with Class III implantable devices.
  
• Strong knowledge of FDA regulations, guidance documents, and CFR requirements.
  
• Expertise in EU MDR and international regulatory frameworks.
  
• Working knowledge of QSR, ISO, and EN standards.
  
• Experience reviewing manufacturing changes & change control processes.
  

Education & Qualifications:

• Bachelor's degree in a relevant field (Medical, Science, Engineering) or equivalent experience.
  
• Ability to work independently, think strategically, and problem-solve proactively.
  
• Strong collaboration and project leadership skills.
  

Ready to Lead Regulatory Excellence?

If you're a regulatory expert ready to drive submissions, ensure compliance, and impact the future of medical technology, we want to hear from you!
Apply today and take the next step in your career with The Ranger Group!PandoLogic. Keywords: Medical Equipment Preparer, Location: Minneapolis, MN - 55405

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