Senior Regulatory Affairs Manager

1w1 week ago

Medtronic

Lafayette, US · Full-time · $154,400 – $231,600

About this role

At Medtronic, begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. As Senior Regulatory Affairs Manager, establish strategy for worldwide product approval submissions focused on US/EU for Acute Care and Monitoring products.

Responsible for execution of submission activities and ensuring regulatory compliance for Acute Care and Monitoring products. Accomplish results through hands-on work and delegation to individual contributors. Collaborate with business partners to develop regulatory strategies supporting business goals and translate into work plans.

Provide direction, leadership, and coaching to specialists to meet schedules and resolve problems. Sponsor a high-performance management culture with clear expectations, targeted career coaching, and performance evaluations. Cultivate a safe, inclusive, and engaging work environment across matrixed organizations.

The ACM OU commits to excellence in innovation and commercialization for long-term growth. Refine product delivery, innovation, and design approaches for integrated portfolio leadership. Continuously improve processes, communication, and alignment with business priorities.

Requirements

Expertise in US and EU regulatory submission processes for medical devices
Experience establishing and executing worldwide product approval strategies
Knowledge of regulatory requirements for Acute Care and Monitoring products
Proven ability to lead interactions with regulatory authorities
Skills in ensuring compliance for advertising and promotion materials
Leadership experience in coaching and developing regulatory teams
Ability to collaborate in matrixed organizations with cross-functional stakeholders
Familiarity with contingency planning and regulatory compliance mechanisms

Responsibilities

Develop global regulatory strategies for Acute Care and Monitoring products to meet business objectives
Collaborate across matrixed organization and with external regulatory authorities to ensure product success
Lead interactions with regulatory agencies as part of strategy development and regulatory reviews
Provide oversight of regulatory review of advertising and promotion materials for compliance
Provide direction, leadership, and coaching to specialists to meet schedules and resolve problems
Sponsor high-performance culture with career coaching, performance evaluations, and talent development
Deliver reports to Senior Management on progress toward OU product submission goals
Provide regulatory guidance on new product registrations, modifications, transfers, and acquisitions