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 LifeOnsite
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary.
The Regulatory Affairs Specialist (RAS) develops and executes strategies for global regulatory approvals to introduce new and modified medical devices to the market. The RAS translates regulatory requirements into project/product requirements, prepares regulatory submissions, and negotiates their approval with regulatory agencies as required. Primary responsibilities include: developing global regulatory strategies; preparing US, EU and international regulatory submissions; providing documentation for international submissions; supporting post-market regulatory compliance activities; evaluating proposed product changes for regulatory impact, all while ensuring timely and high-quality execution of assigned regulatory deliverables.
This role primarily focuses on regulatory support for the US and EU markets, with a wide variety of regulatory tasks to allow you to make the most of your existing knowledge base while growing your RA skill set every day. In this role, you will have primary RA responsibility for multiple Class II and/or Class III products, working within a collaborative team environment that fosters professional development while focusing on meeting business objectives with excellence.
From developing and authoring regulatory submissions to providing critical input on cross-functional development project teams, this role is an excellent opportunity for the right regulatory professional to take their career to the next level at the world’s leading medical device company.
Position Responsibilities
Supports coordinating the planning, preparation, assembly, review and publication of regulatory submissions to the FDA and other worldwide government agencies. Able to write regulatory justifications to support submission filing decisions.
Supports compiling and producing materials required in submissions, license renewal and annual registrations.
Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability.
Supports interactions with regulatory authorities during the development and review process to ensure submission approval.
RA Representative on cross functional project teams to communicate regulatory requirements, perform regulatory assessments and prepare regulatory documentation according to a defined timeline.
Perform regulatory assessments on product changes that may be initiated internally or externally.
Recommend changes for labeling, manufacturing, marketing, and clinical documentation for regulatory compliance.
Review and approve engineering change orders per company procedures, to assure compliance with regulatory requirements.
Work with global regions to solve internal regulatory blocks within the supply chain.
Creation and/or maintenance of Technical Document, GSPRs, Declaration of Conformity, Risk Classification Assessments.
Review and assess impact of NCMRs in a timely manner to support manufacturing goals.
Maintain current knowledge of the development and changes to applicable laws, regulations and industry standards, and assist in the dissemination of this information to the appropriate individuals with the company.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle maintenance and develop solutions with other members of regulatory and related teams.
Participation in internal and external audit preparedness.
Other duties as assigned.
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Minimum Requirements:
Bachelor’s Degree in Engineering, Life Sciences, or related medical/scientific/technical area of focus with 2+ years of related experience, or a Masters degree with 0 years of experience.
Desired/Preferred Qualifications
Understanding of engineering concepts and scientific terminology
Ability to understand, evaluate, and provide guidance on scientific literature, reports, and rationale
Experience reviewing technical and design specifications
Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
Superior interpersonal skills
Excellent analytical thinking skills
Ability to effectively manage multiple projects and priorities
Proven ability to work effectively in cross-functional teams
Excellent written and verbal communications skills
Strong organization and time management skills
Presentation skills for small to mid-sized groups
Detail-oriented
Ability to be flexible with changing priorities
Submission-related word processing skills
Some overnight travel required
For 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 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.
U.S. Work Authorization & Sponsorship
At 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.
Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued.
Benefits & 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.
This 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 plans
About MedtronicWe 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 95,000+ 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.
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.
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