Associate Regulatory Affairs Specialist

Regulatory Affairs Associate

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.

The Regulatory Affairs Associate supports regulatory strategy and submissions to ensure medical devices comply with applicable global regulatory requirements. The role assists in preparing documentation, maintaining regulatory files, and coordinating with cross functional teams to obtain and maintain product approvals.

Additionally, supports regulatory activities to maintain internal data integrity for products already in the marketplace. Primary responsibilities include: supporting global regulatory strategies; supporting 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 collaborate with RAS and Sr. RAS on 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 supporting internal systems, supporting regulatory submissions and 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.
• Maintain regulatory databases and document management systems.
• Other duties as assigned.

Basic Qualifications

• Bachelor's Degree in Engineering, Life Sciences, or related medical/scientific/technical area of focus

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

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.

Medtronic 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):$60,800.00 - $91,200.00This 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 plans

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