Sr. Regulatory Affairs Specialist- Clinical

Medtronic; San Antonio (TX); Remote; USD 117,000 - 138,000; Full time

Job summary

A leading medical device firm is seeking a Regulatory Affairs professional to develop strategies supporting innovations in diabetes care. The role offers a salary up to $138,000, remote work flexibility, and a comprehensive benefits package. Ideal candidates have strong regulatory experience, particularly in medical devices, and the ability to manage multiple projects effectively.

Benefits

Salary up to $138,000

Comprehensive benefits package

Tuition assistance

401(k) plan with employer contribution

Short-term incentive plan

Qualifications

• 4+ years of regulatory affairs experience in medical devices.
• Direct experience with Class III/II medical devices for FDA and EU submissions.
• Strong proficiency in regulatory intelligence and submission preparation.

Responsibilities

• Develop and refine regulatory strategies for diabetes devices.
• Manage projects providing regulatory support for new products.
• Prepare clinical submissions for global regulatory agencies.

Skills

Regulatory affairs experience

Time management

Multitasking

Education

Bachelor’s degree in a relevant field

Advanced degree in a scientific discipline

Job description

Employer Industry: Medical Device Manufacturing

Why consider this job opportunity:

• Salary 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, tuition assistance, and a 401(k) plan with employer contribution
• 100% remote work opportunity, providing flexibility in your work environment
• Opportunity to work in a rapidly evolving field with a focus on innovation and patient care
• Chance to collaborate with cross-functional teams and contribute to the development of next-generation diabetes devices

What to Expect (Job Responsibilities):

• Develop and refine clinical regulatory strategies to support innovations in the Diabetes business
• Maintain proficiency of worldwide regulatory intelligence to inform clinical regulatory strategies
• Manage projects to provide regulatory support for new products and existing product changes
• Prepare clinical submissions for FDA, European, and other global regulatory agencies
• Interact directly with regulatory agencies on projects/products and resolve submission issues

What is Required (Qualifications):

• Bachelor’s degree in a scientific, healthcare, or regulatory-related field and 4+ years of regulatory affairs experience, preferably with 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 III/II medical devices for both FDA and EU
• Proven experience preparing and submitting regulatory filings to the FDA, EU MDR, and other global regulatory agencies
• Strong time management skills with the ability to multitask and meet project 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 involvement in regulatory submissions
• History of successful device submissions

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