Senior Regulatory Affairs Lead, Medical Devices

Medtronic plc; North Haven (CT); On-site; USD 121,000 - 181,000; Full time

Benefits offered by this job

Health, Dental and vision insurance

Health Savings Account

Tuition assistance/reimbursement

Job summary

Medtronic plc is seeking a Regulatory Affairs Lead to guide regulatory strategies for medical devices across the product lifecycle in the United States. You will oversee regulatory activities, collaborate with cross-functional teams, and interact with regulatory authorities to support submissions and approvals.

The role emphasizes building a high-performance team, talent development, and ensuring compliance with global regulations including the EU MDR and FDA interactions.

Qualifications

• Bachelor’s degree is required.
• Minimum of 5 years of relevant experience or an advanced degree with a minimum of 3 of relevant experience.

Responsibilities

• May serve as the regulatory lead for one or more new product development projects.
• Oversee the day-to-day regulatory activities of the Stapling Regulatory Affairs team, with potential for people management.
• Develop regulatory strategies for existing, new, and modified medical devices to meet business objectives and collaborate across a matrixed organization.
• Lead interactions with regulatory agencies as part of strategy development and the support of regulatory reviews.
• Provide guidance on regulatory requirements necessary for contingency planning and ensure compliance with regulations.
• Partner with quality, engineering, clinical, manufacturing, and commercial teams to ensure regulatory compliance throughout the product lifecycle.

Skills

Regulatory affairs

Leadership

Cross-functional collaboration

Education

Bachelor’s degree

Advanced degree

Job description

Medtronic plc is seeking a Regulatory Affairs Lead to guide regulatory strategies for medical devices across the product lifecycle in the United States. You will oversee regulatory activities, collaborate with cross-functional teams, and interact with regulatory authorities to support submissions and approvals.

The role emphasizes building a high-performance team, talent development, and ensuring compliance with global regulations including the EU MDR and FDA interactions.