Principal Regulatory Affairs Specialist - Onsite

the opportunity phase through commercialization. The principal specialist has primary responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide.

Sustaining regulatory responsibilities includes reviewing product labeling changes to ensure that regulatory requirements continue to be met, documenting "no file" decisions, reviewing promotional materials, and ensuring that our product technical documentation is current and accurate.

This position is best suited for individuals with a broad background across the full regulatory life cycle of medical devices and strong working knowledge and experience in reviewing advertising and promotional materials for medical devices.

Responsibilities may include the following and other duties may be assigned. Provide regulatory affairs support for new products, product modifications, and currently marketed products across domestic and international markets.

Prepare, review, and support regulatory submissions, including FDA submissions (Pre-Subs, 510(k)s), CE Mark, and other international filings, to support timely approvals and market release.

Collaborate with regulatory affairs specialists, engineers, technical experts, and cross-functional teams such as engineering, quality, clinical, marketing, and business units to resolve regulatory issues and support product development.

Interact with FDA and other regulatory authorities at the reviewer level, including participation in submission reviews, issue resolution, and negotiations as needed.

Review labeling, promotional, and advertising materials, as well as product change documentation, to determine whether regulatory submission or approval is required.

Support regulatory compliance activities, including manufacturing site registration, audits, recalls, and maintenance of required regulatory documentation.

Maintain current knowledge of applicable domestic and international regulations, guidelines, and standards, and apply that knowledge to regulatory strategy and execution.

Provide regulatory strategy input and technical guidance for new technologies and product changes, considering global regulatory requirements.

Communicate business and product information to international regulatory teams and business partners to support development of regulatory strategies and requirements.

Maintain strong working relationships with regulatory agency personnel and internal stakeholders. Create or revise departmental procedures as needed to improve operations or reflect changing regulatory requirements.

Manage multiple projects and priorities to meet business and project timelines. Mentor or supervise other regulatory affairs staff, as assigned.

Perform other duties as assigned. Must Have: Minimum Requirements Bachelor's degree required Minimum of 7 years of relevant experience, or an advanced degree with a minimum of 5 years of relevant experience.

Nice to Have Experience successfully achieving FDA clearance through a 510(k) submission Experience interacting directly with the FDA Experience managing or contributing to multiple regulatory submissions Familiarity with medical device regulatory lifecycle management.

Salary ranges for U.S (excl. PR) locations (USD):$120,000.00 - $180,000.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range applies across the United States, excluding Puerto Rico and certain locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location.

Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).