Regulatory Operations Specialist

Medtronic in; Lafayette (CO); Remote; USD 74,000 - 112,000; Full time

Job summary

A leading company in healthcare technology is seeking a Regulatory Operations Specialist to enhance regulatory systems and processes. This role involves managing FDA registrations, collaborating with various teams, and ensuring compliance with regulations. The position offers opportunities for global collaboration and insights into international structures.

Benefits

Health, dental, vision insurance

Tuition reimbursement

401(k) and stock purchase plans

Paid time off and holidays

Qualifications

• Bachelor's degree with at least 2 years of relevant experience.
• Strong understanding of FDA regulations related to medical device registration and listing.

Responsibilities

• Act as the primary contact for registration and listing.
• Manage FURLS accounts in collaboration with O/O, OCs, and U.S. Agents.
• Work with regulatory teams to ensure compliance with FDA regulations.

Skills

Strong understanding of FDA regulations

Organizational skills

Communication skills

Initiative

Flexibility

Education

Bachelor's degree

Tools

Microsoft Office

Adobe Acrobat

Documentum

SharePoint

Sitebuilder

Job description

Regulatory Operations Specialist (Finance)

We anticipate the application window for this opening will close on - 28 May 2025.

At Medtronic, you can begin a lifelong career of exploration and innovation, 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

Position is open to remote in the US or Bogota, Colombia.

This role is part of the Medtronic Clinical & Regulatory Solutions (MCRS) organization, focusing on enhancing regulatory systems and processes. Key responsibilities include collaborating with the Registration and Listing Value Stream team to manage FDA Establishment Registrations, Device Listings, annual registration, and audits. It also involves managing the Owner/Operator (O/O) account, guiding Official Correspondents (OC), US Agents, and OU Regulatory teams, and contributing to the UDI system to ensure data integrity.

Key Responsibilities

• Act as the primary contact for registration and listing, ensuring effective communication with stakeholders.
• Manage FURLS accounts in collaboration with O/O, OCs, and U.S. Agents.
• Work with regulatory teams to ensure compliance with FDA regulations on registrations and listings.
• Oversee annual registration processes, including renewals and data reviews.
• Maintain documentation to demonstrate compliance and accuracy.

Joining MCRS offers opportunities such as global collaboration, visibility into international structures, and insights into various processes across Medtronic.

Additional Responsibilities

• Maintain FDA Device Establishment Registration and Device Listings.
• Support regulatory systems and projects daily.
• Interface with teams to address queries and resolve issues.
• Assist in audits and inspections, providing consultation.
• Conduct training for stakeholders.
• Participate in initiatives to improve regulatory processes and systems.

Minimum Requirements

• Bachelor's degree with at least 2 years of relevant experience.
• Strong understanding of FDA regulations related to medical device registration and listing.

Preferred Qualifications

• Experience with Device Registration and Listing Module (DRLM) in FURLS and FDA interactions.
• Ability to collaborate with leadership.
• Initiative and ability to perform under pressure.
• Experience with expense reports and purchase cards.
• Proficiency in Microsoft Office, Adobe Acrobat, Documentum, SharePoint, and Sitebuilder.
• Strong organizational and communication skills.
• Flexibility, self-motivation, professionalism, and understanding of UDI requirements.

Physical Job Requirements

These describe the general nature and level of work. Reasonable accommodations may be made for individuals with disabilities. Office roles require mobility, computer interaction, and communication with peers and co-workers.

Benefits & Compensation

Medtronic offers a competitive salary and benefits package, supporting employees at every career and life stage. Salary ranges for U.S. locations (excluding PR): $74,400 - $111,600. This role is eligible for the Medtronic Incentive Plan (MIP). Benefits include health, dental, vision, HSA, FSA, life insurance, disability leave, tuition reimbursement, and well-being programs. Additional benefits are available for all regular employees, including 401(k), stock purchase plans, paid time off, holidays, and more. Details are available on our website.

About Medtronic

We lead global healthcare technology, aiming to solve the most challenging health problems. Our mission is to alleviate pain, restore health, and extend life, driven by a team of over 95,000 passionate people. We innovate across R&D, manufacturing, and solutions, fostering diversity and commitment to excellence.

Learn more about our mission and diversity initiatives on our website.

Medtronic is committed to equal employment opportunity and reasonable accommodations for individuals with disabilities. We consider qualified applicants with arrest or conviction records in accordance with applicable laws.