Senior Regulatory Operations Specialist - Irvine

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 Life

Responsibilities may include the following and other duties may be assigned.

• Responsible for preparing, publishing, quality control, and delivering paper and electronic components of all submissions, including initial large marketing authorization applications (510Ks, PMAs, supplements, 30 days, 180 days, etc.) and standard electronic technical documents (e-CTD).
• Submissions are produced with electronic publishing tools in compliance with document management standards.
• Working knowledge of Medical device Regulated Master Data management & RIM systems such as Veeva, PTC Windchill, or Liquent Insight and reporting using BI tools.
• Knowledge of Medical device regulations in the US & EU for Product licensing, registration, UDI data reporting, submission of e-STAR format, facility registrations, device listings & maintenance.
• Responsible for enterprise-wide regulatory management systems activities, including systems coordination, training others, developing and implementing plans, and providing input to systems designs.
• Responsible for obtaining CFGs and COEs to support international registrations, HUE filings in the US, and licensing/registration in the US & EU.
• Responsible for administering New & Changing regulations assessment process and coordination with cross-functional SMEs, metrics & reporting for Management Reviews.
• Ensures continuous efficiency and effective process improvement measurements, including quality system procedure updates, document change orders routing, and CAPA investigations.
• Prepares, submits, tracks, indexes, and archives paper and electronic submissions, including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials.

Required Knowledge and Experience:
Requires a Baccalaureate degree

Minimum of 4 years of regulatory affairs experience or advanced degree with a minimum of 2 years experience.

Nice to Have

• Prior Regulatory Ops experience in medical devices with class II & III products
• Experience with EU MDR regulations, including AR verification
• Audit experience with MDSAP, EU MDR, and FDA is a plus
• Advance data analytics and reporting capabilities

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.

Benefits & Compensation

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):$91,200.00 - $136,800.00

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).

Medtronic benefits and compensation plans

About Medtronic

We 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 90,000+ 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.

At Medtronic, most positions are posted on our career site for 3-7 days.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.