Regulatory Affairs Manager

Medtronic; Lafayette (CO); On-site; USD 120,000 - 170,000; Full time

Job summary

Medtronic in Lafayette, CO is seeking a Regulatory Affairs Manager to establish strategies for worldwide product approval and submission activities, focusing on U.S. and EU regulatory compliance for Lung Health and Gynecologic devices.

The role requires onsite work four days a week at specified Surgical locations and leadership of cross-functional regulatory teams to meet business goals and regulatory timelines.

Qualifications

• Bachelor's degree required.
• 7+ years of relevant experience or 5+ with advanced degree.
• Regulatory affairs experience in medical devices preferred.

Responsibilities

• Oversee day-to-day Lung Health and Gynecologic Regulatory Affairs team operations.
• Develop regulatory strategies for global submissions and ensure alignment with business objectives.
• Collaborate with cross-functional teams to support product lifecycle regulatory needs.
• Lead interactions with regulatory agencies for strategy development and submissions.
• Ensure compliance with applicable regulations and provide guidance on regulatory requirements.
• Monitor and improve regulatory submission processes and timelines.

Education

Bachelor's degree

Job description

We anticipate the application window for this opening will close on - 19 Oct 2026

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

As the Regulatory Affairs Manager, you will be responsible for establishing strategies for worldwide product approval and submission activities, directly executing submission activities focused on the U.S. and EU, and ensuring regulatory compliance for Lung Health and Gynecologic products within the Surgical organization. The Regulatory Affairs Manager is expected to achieve results through hands-on leadership and the delegation of responsibilities to individual contributors. This role requires collaboration with business partners to develop regulatory strategies that support business goals and translate those strategies into work plans for the Regulatory Affairs teams.

This position requires working onsite four days per week at one of our Surgical locations: Lafayette, CO; Mounds View, MN; North Haven, CT; or Mansfield, MA.

Responsibilities may include the following, as well as other duties that may be assigned.

• Oversee the day-to-day functions of the Lung Health and Gynecologic Regulatory Affairs team.
• Become actively involved in daily operations to meet schedules or resolve complex problems.
• Develop regulatory strategies for existing, new, and modified medical devices to meet business objectives, and collaborate across a matrixed organization to ensure the global success of products.
• Collaborate with external regulatory authorities and cross-functional stakeholders to ensure alignment of regulatory strategies with business objectives.
• 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 all applicable regulations.
• Partner with quality, engineering, clinical, manufacturing, and commercial teams to ensure regulatory compliance throughout the product lifecycle.
• Manage team performance, resource planning, talent development, succession planning, and employee engagement initiatives.
• Provide oversight of regulatory reviews of advertising and promotional materials to ensure that product claims and materials align with applicable local guidance and regulations.
• Sponsor and actively monitor a high-performance management culture where employees have clear performance expectations.
• Provide targeted career coaching and feedback; manage and develop team members at all levels of experience.
• Clearly identify and communicate talent differentiation, and ensure that development actions and rewards align accordingly.
• Conduct timely and candid performance evaluations and support meaningful development activities.
• Cultivate a safe, inclusive, and engaging work environment.
• Provide periodic progress reports or presentations to senior management regarding OU product submission goals.
• Continuously improve operating mechanisms, communication pathways, and processes to increase efficiency.
• Work with your team to ensure understanding and alignment of regulatory work to business goals and priorities.
• Direct or perform the coordination and preparation of document packages for regulatory submissions, internal audits, and inspections across all areas of the company.
• Lead or compile all materials required for submissions, license renewals, and annual registrations.
• Recommend changes to labeling, manufacturing, marketing, and clinical protocols to maintain regulatory compliance.
• Monitor and improve tracking and control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.

Required Knowledge and Experience:

• Bachelor's degree required.
• Minimum of seven years of relevant experience or an advanced degree with a minimum of five years of relevant experience .

Preferred Qualifications:

• Five or more years of medical device regulatory affairs experience.
• Degree in engineering or an advanced degree.
• Proven track record of leading high-performing teams.
• Ability to recognize and develop key talent.
• Excellent knowledge of U.S., European, and international regulations, including the EU MDR, as well as standards applicable to products of all risk classifications.
• Experience interacting with the FDA and/or other regulatory agencies, including Q-Submission preparation and meetings, submission issue meetings, and other interactions.
• Proven ability to prioritize work, manage time effectively, and meet project deadlines.
• Ability to work effectively in dy