Principal Regulatory Affairs Specialist - Hybrid

Medtronic; United States; Remote; USD 118,000 - 178,000; Full time

Job summary

An established industry player is seeking a Principal Regulatory Affairs Specialist to lead regulatory compliance for innovative medical devices. This role involves collaborating with diverse teams to develop regulatory strategies for Class I, II, and III devices, ensuring readiness for global submissions. The successful candidate will navigate complex regulatory landscapes, document decisions, and support audits, all while contributing to a mission that champions healthcare access and equity. If you're passionate about making a difference in healthcare technology and thrive in a collaborative environment, this opportunity is perfect for you.

Benefits

Health insurance

Dental insurance

Vision insurance

401(k) plan with employer match

Paid time off

Tuition assistance

Employee Stock Purchase Plan

Short-term disability

Long-term disability

Flexible Spending Account

Qualifications

• 7+ years of regulatory affairs experience or advanced degree with 5+ years.
• Experience with Design History File and regulatory submissions.

Responsibilities

• Collaborate with product teams for global regulatory strategies.
• Prepare document packages for regulatory submissions.
• Ensure compliance with global regulatory requirements.

Skills

Regulatory Affairs

Compliance with US and EU regulations

Document preparation for regulatory submissions

Collaboration with cross-functional teams

Critical thinking

Education

Bachelor's degree

Advanced degree (preferred)

Job description

We anticipate the application window for this opening will close on - 23 May 2025.

At Medtronic, you can begin a lifelong 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 Principal Regulatory Affairs Specialist supports product teams for new/updated Class I, II, and III devices across two operating units with diverse products and needs. Collaboration with cross-functional teams (e.g., R&D, Clinical, Quality, Marketing) to incorporate global requirements into project documentation is key, ensuring submission-ready outputs for global submissions. This role also supports the Total Product Lifecycle (TPLC) for capital equipment, disposable/sterile surgical tools, and CSF/critical care devices in the cranial and spine space.

The role involves ensuring compliance with US and EU regulatory requirements, partnering with international teams, documenting regulatory decisions, and supporting audits and inspections. It requires keeping senior management informed of regulatory statuses and issues.

The successful candidate should work well with advanced regulatory concepts, develop regulatory strategies, and collaborate across the organization.

Responsibilities include:

• Collaborating with product teams to incorporate global requirements into deliverables for submissions.
• Developing and supporting global regulatory strategies for Class I, II, and III devices/accessories.
• Coordinating and preparing documentation for regulatory submissions, audits, and inspections.
• Leading or compiling materials for submissions, license renewals, and registrations.
• Ensuring product compliance with global regulations, recommending changes as needed.
• Monitoring and improving tracking systems.
• Staying updated on regulatory procedures and changes.
• Interacting with regulatory agencies as needed.

Qualifications

Must-Have: Minimum Requirements

• At least 7 years of regulatory affairs experience, or 5 years with an advanced degree.

Nice to Have:

• Experience with Design History Files and regulatory submissions.
• Experience in a corporate, matrix environment.
• Critical thinking and collaboration skills.
• Mentorship abilities for junior team members.

Physical Job Requirements

This description covers the general nature of the work. Reasonable accommodations may be provided for disabilities. Office role requirements include mobility, interaction with computers, and communication with colleagues.

Benefits & Compensation

We offer a competitive salary and benefits package, including health insurance, savings accounts, life insurance, tuition reimbursement, incentive plans, 401(k), paid time off, and more. Salary ranges for U.S. locations are $118,400 - $177,600, with eligibility for incentive plans. Benefits vary by location and employment status.

About Medtronic

We lead global healthcare technology, aiming to solve challenging health problems. Our mission is to alleviate pain, restore health, and extend life, driven by a diverse team of over 95,000 people. We innovate across R&D, manufacturing, and more, committed to diversity and inclusion. Learn more here.

Medtronic is an equal opportunity employer, providing accommodations for individuals with disabilities. For roles involving work in Los Angeles County, additional job duty information is available here.