Regulatory Affairs Specialist

Regulatory Affairs SpecialistCareers 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.Medtronic's Access and Instruments Operating Unit develops technologies that support surgical access and enable precise, efficient procedures across a range of care settings. The portfolio includes products and solutions designed to help clinicians access the surgical site, perform procedures with greater control, and support workflow in the operating room. As part of Medtronic's broader mission, this team is focused on advancing innovative tools that help improve procedural outcomes and support high-quality patient care.As a Regulatory Affairs Specialist in the Access and Instruments Operating Unit, you will play an important role in supporting innovative medical technologies throughout the product lifecycle. You will partner with cross-functional teams to prepare regulatory documentation, assess the impact of product changes, maintain regulatory systems, and help ensure compliance with global requirements. This role is ideal for someone who thrives in a collaborative environment, enjoys navigating complex regulatory requirements, and is energized by the opportunity to support technologies that improve patient care.In this role, you will:Partner with multidisciplinary teams to communicate regulatory requirements and support regulatory strategy.Provide regulatory input to product development, lifecycle planning, and change control activities.Assess the regulatory impact of proposed design, labeling, manufacturing, and process changes.Prepare, review, and coordinate documentation for regulatory submissions, renewals, registrations, and related filings.Support audits, inspections, and regulatory authority interactions as needed.Participate in risk management activities and help ensure regulatory considerations are addressed appropriately.Monitor and support tracking systems used to manage regulatory deliverables and documentation.Stay current on applicable regulations, standards, and guidance documents relevant to assigned products and markets.Collaborate with internal stakeholders to help resolve issues, manage priorities, and keep regulatory activities on track.Contribute to process improvements and help strengthen regulatory practices across the organization.To be considered for this role, you must have:Bachelor's degree requiredMinimum of 2 years of relevant experience, or advanced degree with a minimum of 0 years of relevant experience.Preferred qualifications include:Experience with U.S. FDA and international regulatory requirements for medical devicesFamiliarity with EU MDR, MDD, ISO 13485, ISO 14971, and related standardsExperience supporting regulatory submissions, audits, or inspectionsStrong written and verbal communication skillsStrong organizational skills with the ability to manage multiple prioritiesExperience collaborating in a cross-functional, fast-paced environmentFamiliarity with medical device product development or lifecycle managementRAC certification or progress toward certificationExperience working with Notified Bodies or global regulatory agenciesFor Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.Physical Job RequirementsThe 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. 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.U.S. Work Authorization & SponsorshipAt Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.Recruitment Fraud AlertWe are aware of phishing scams targeting job seekers. Please keep the following in mind:Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at View email address on click.appcast.io & CompensationMedtronic 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):$74,400.00 - $111,600.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).The base salary range is applicable across the United States, excluding Puerto Rico and specific 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).The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.Further details are available at the link below:Medtronic benefits and compensation plansIt 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.If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.