Global Regulatory Affairs Manager — Medical Devices

Medtronic plc; United States; In loco; USD 121.000 - 181.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

401(k) plan with match

Paid time off

Employee Stock Purchase Plan

Descrizione del lavoro

Medtronic in the United States is seeking a Regulatory Affairs Manager to establish strategies for worldwide product approval and submission activities, focusing on Lung Health and Gynecologic devices within the Surgical division.

You will lead hands-on regulatory planning, coordinate with business partners to translate strategies into work plans, and drive compliant submissions for the U.S. and EU markets while developing a high-performing team.

Competenze

• Bachelor’s degree is required.
• Minimum of seven years of relevant regulatory experience, or five years with an advanced degree.
• Strong knowledge of U.S., European, and international regulations, including EU MDR.
• Experience interacting with the FDA or other regulatory authorities.

Mansioni

• Oversee Lung Health and Gynecologic Regulatory Affairs day-to-day operations.
• Develop regulatory strategies to meet business objectives across global markets.
• Lead interactions with regulatory agencies as part of strategy development and submissions.
• Ensure compliance with applicable regulations throughout the product lifecycle.
• Partner with quality, clinical, manufacturing, and commercial teams to align regulatory work with business goals.

Conoscenze

Regulatory affairs leadership

FDA interactions

Cross-functional collaboration

Regulatory strategy

Formazione

Bachelor's degree

Engineering degree preferred

Descrizione del lavoro

Medtronic in the United States is seeking a Regulatory Affairs Manager to establish strategies for worldwide product approval and submission activities, focusing on Lung Health and Gynecologic devices within the Surgical division.

You will lead hands-on regulatory planning, coordinate with business partners to translate strategies into work plans, and drive compliant submissions for the U.S. and EU markets while developing a high-performing team.