Senior Regulatory Affairs Specialist - Global Markets - Onsite

Role Overview

The Sr. Regulatory Affairs Specialist develops global regulatory strategies and leads worldwide submissions for high-risk medical devices. They will manage strategy meetings, submissions, and deficiency responses to ensure approval for new product entry and device changes. They will also ensure global compliance, participate in audits, and provide support to project teams.

Key Responsibilities

• Global Regulatory Strategy & Submissions: Partner with business unit and geography regulatory teams to develop and execute global submission strategies, deficiency responses, and product registration plans for new and modified products.
• Product Lifecycle Management: Provide regulatory assessments and approvals for engineering change orders, labeling changes, and product releases to ensure continuous compliance across global markets.
• Agency Interaction & Compliance: Act as a key liaison to international regulatory agencies at the reviewer level; support manufacturing site registrations, audits, post-market vigilance, and product recalls.
• Cross-Functional Technical Support: Collaborate with R&D, engineering, and supply chain teams to identify, address, and resolve potential regulatory obstacles and compliance blocks throughout the product lifecycle.
• Regulatory Intelligence & Mentorship: Maintain up-to-date knowledge of global regulations and industry standards to inform company strategy; provide guidance and training to junior team members.
• Strategic Focus: Lead the strategic direction and planning for global regulatory projects, ensuring timely market approvals and compliance with applicable regulations.

Must Have

• Minimum Requirements: Bachelor’s degree in a scientific discipline or equivalent, Minimum 4 years of regulatory affairs experience in the medical device industry, or an advanced degree with 2 years of experience.
• Nice To Have: 5-8 years of medical device industry experience in regulatory affairs, Advanced degree in a scientific, engineering, or health discipline, In-depth experience with global regulatory requirements, including MDR, ISO 14971, ISO 13485, MDSAP, and quality standards, History of successful international device submissions, including LATAM, APAC, and CEEMEA regions, Experience with Class III medical devices (PMA).

Physical Job Requirements

While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.

U.S. Work Authorization & Sponsorship

We are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

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Benefits & Compensation

Salary ranges for U.S. (excl. PR) locations (USD): $92,000.00 - $138,000.00. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).