Sr. Regulatory Affairs Specialist- Clinical

Medtronic; Minneapolis (MN); Remote; USD 100,000 - 138,000; Full time

Job summary

A leading medical technology company is seeking a Regulatory Affairs Specialist to develop and refine regulatory strategies for next-generation diabetes products. Candidates should have a degree in a related field and significant experience in regulatory affairs within the medical device industry. The role is 100% remote, offering a competitive salary and comprehensive benefits package.

Benefits

Comprehensive benefits package

Flexible work arrangements

Tuition assistance

Qualifications

• 4+ years of regulatory affairs experience in medical device submissions.
• Direct experience in the medical device industry, particularly with Class II/III devices.
• Proven ability to prepare and submit regulatory filings globally.

Responsibilities

• Develop and refine clinical regulatory strategies for diabetes products.
• Prepare clinical submissions for FDA and international regulatory agencies.
• Interact with regulatory agencies on project-related issues.

Skills

Regulatory affairs experience

Organizational skills

Time management skills

Education

Bachelor’s degree in a scientific field

Advanced degree in a scientific field

Job description

Employer Industry: Medical Device Manufacturing

Why consider this job opportunity:

• Salary range up to $138,000
• Eligible for a short-term incentive called the Medtronic Incentive Plan (MIP)
• Comprehensive benefits package including health, dental, and vision insurance
• Opportunities for career advancement and growth within a leading healthcare technology company
• 100% remote work position with flexible work arrangements
• Commitment to employee well-being through various programs, including tuition assistance and global well-being initiatives

What to Expect (Job Responsibilities):

• Develop and refine clinical regulatory strategies for next-generation diabetes products in collaboration with cross-functional teams
• Maintain proficiency in worldwide regulatory intelligence to support innovative regulatory strategies
• Manage projects to provide regulatory support for new products and existing product changes
• Prepare clinical submissions for FDA, European, and international regulatory agencies
• Interact directly with regulatory agencies on project-related issues and submissions

What is Required (Qualifications):

• Bachelor’s degree in a scientific, healthcare, or regulatory-related field and 4+ years of regulatory affairs experience, preferably in medical device submissions
• OR an advanced degree in a scientific, healthcare, or regulatory-related field and 2+ years of regulatory affairs experience
• Direct experience in the medical device industry, particularly with Class II/III devices for FDA and EU
• Proven experience preparing and submitting regulatory filings to global regulatory agencies
• Strong organizational and time management skills to handle multiple projects and meet deadlines

How to Stand Out (Preferred Qualifications):

• 5-8 years of medical device industry experience, with at least 2-3 years in regulatory and clinical roles
• Advanced degree in a scientific discipline (engineering, physical/biological, or health sciences)
• Experience working in a regulated biotechnology environment with extensive regulatory submissions
• A history of successful device submissions

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