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At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

The newly created ACM OU is committed to excellence in innovation and commercialization to pursue our vision and long-term business growth. The ACM OU R&D organization is refining its product delivery, innovation, and commercialization approach to enable product leadership across all segments of our product portfolio. This will require enhancing our innovation processes, refining our design and delivery approaches to deliver an integrated and comprehensive portfolio that enables product development excellence across ACM.

We believe that when people from different cultures, genders, and points of view come together, innovation is the result — and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

We are looking for this role to be based out of Boulder, CO. We may consider other Medtronic locations for the right talent.

As the International Regulatory Affairs Director, you will be pivotal in overseeing and executing regulatory activities for our company's global market expansion and sustaining operations. Your role will focus on ensuring compliance with international regulations, driving robust regulatory strategies, and executing efficient product approvals across diverse jurisdictions. This position demands decisive leadership, strategic acumen, and a strong emphasis on effective execution.

Key Responsibilities:

Regulatory Strategy Development and Execution:

• Develop and execute global regulatory strategies to support market entry plans.
• Provide hands-on regulatory guidance to cross-functional teams, ensuring rigorous compliance throughout the product lifecycle.

Precise Execution of Global Regulatory Submissions:

• Lead the precise preparation, submission, and swift approval of regulatory filings for new product licenses, amendments, and renewals worldwide.
• Ensure meticulous preparation of submissions, ensuring accuracy, completeness, and strict adherence to regulatory requirements.

Compliance Oversight and Risk Management:

• Vigilantly monitor evolving global regulatory landscapes and swiftly assess potential impacts on product portfolios.
• Identify regulatory risks and execute proactive mitigation strategies to maintain unwavering compliance with international regulations.

Documentation Management and Certificates:

• Ensure documents meet the specific requirements of each country, including authentication at consulates or through appropriate government channels.
• Manage process of ordering certificates to foreign government

Tender and Distribution Support

• Coordinate the preparation and compilation of tender documentation in response to requests from clients or government agencies.
• Manage customs and internal systems hold situations by liaising with authorities and relevant stakeholders to facilitate the release of shipments.

Leadership in Execution and Team Development:

• Establish and lead a high-performing global regulatory affairs team dedicated to swift execution and compliance excellence.
• Cultivate a culture of precision execution, continuous improvement, and professional development within the regulatory affairs function.

Qualifications:

• Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred.
• Extensive experience in regulatory affairs (typically 10+ years) and management (typically 7+ years) within pharmaceuticals, biotechnology, medical devices, or related industries, with a strong track record of execution.
• Exceptional communication skills and comfortable with global cultural differences.
• Profound knowledge of global regulatory requirements (FDA, MDR, NMPA, PMDA, etc.) and regulatory affairs principles.
• Decisive leadership skills with an emphasis on driving execution and achieving results aligned with strategic business goals.
• Proven ability to manage regulatory affairs teams effectively and foster a culture of commitment and compliance.

Additional Requirements:

• Willingness and ability to travel domestically and internationally as required.
• Willingness to work outside of normal working hours to accommodate communication with global partners.
• Proficiency in relevant software applications and regulatory databases.

Working Conditions:

• Fast-paced and dynamic work environment demanding adaptability and delivering results.
• Interaction with global teams and regulatory authorities across multiple time zones.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: 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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$181,600.00 - $272,400.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).This position is eligible for an annual long-term incentive plan.

About Medtronic

Medtronic benefits and compensation plans

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

At Medtronic, most positions are posted on our career site for 3-7 days.