Regulatory Operation Specialist (Remote) at Medtronic in Los Angeles, California

Job Description:

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
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

The Medtronic Diabetes Group offers an integrated system combining our MiniMed Insulin Pump Therapy with our Continuous Glucose Monitoring systems. We are working with the global community to change the way people manage diabetes. Together, we will transform diabetes care by expanding access, integrating care, and improving outcomes; so people with diabetes can enjoy greater freedom and better health. Our strategy is to become a holistic diabetes management company focused on making a real difference in outcomes and cost. We want to transform healthcare toward value-based models by driving both product and business model innovation with the goal of elevating patient experience, improving clinical outcomes and lowering the total cost of care for our customers.

This is a cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe

Careers That Change Lives

The Regulatory Operations Specialist will be the key point of contact for both product release and publication of regulatory submissions for both US and International markets, ensuring timely and complete compliance with regulations and internal procedures. The successful candidate will participate in a diverse array of regulatory operations activities related to technical documentation, UDI submissions, product release, and formatting and publication of submissions to government agencies. As subject-matter expertise deepens, the individual will have the opportunity to participate in, and occasionally lead, process improvement projects.

Responsibilities may include the following and other duties may be assigned

• Understand and operate within regulatory guidelines on electronic submissions, general regulatory requirements, and internal procedures

• Review and approve requests for product release and resolve blocked orders , helping to ensure timely and accurate delivery of products to patients

• Keep systems of record updated with current and accurate information pertaining to regulatory work

• Partner with team members and customers to share knowledge and solve problems

• Provide formatting and publication expertise to agency submissions

• Identify opportunities for process improvement and participate in projects as a subject matter expert

• Maintain and update assigned standard operating procedures, policies, work instructions, and user guides, as needed

• Lead training on Regulatory Affairs systems and procedures, troubleshooting and providing problem resolution for complicated issues

• Lead data collection and management for UDI submissions in US and international markets

• Lead and s upport special projects under direction from manager including, but not limited to , collecting and analyzing data, and presenting results

• Foster relationships across functional groups and business units to share best practices

Must Have; Minimum Requirements

• Bachelor 's Degree with 2 years of medical device experience with work experience in regulatory affairs/regulatory operations or quality systems


• Or advanced degree with 0 years of experience

D esired /P referred Q ualifications

• Knowledge of GTS licensing , UDI coordination and EU MDR preferred

• Advanced customer service skills to interact with individuals at various levels of the organization and external contacts , when necessary

• Strong organizational and time management skills. This includes meticulous attention to detail and the ability to complete multiple simultaneous assignments within a given period and with minimal supervision

• Experience with Agile, Documentum or other document management systems used in the medical device or pharmaceutical industry

• Advanced k nowledge and use of Microsoft Office Suite applications, Outlook, Word, Excel and Adobe Acrobat.

• Analytical and problem-solving skills associated with software and complex documents, including the ability to detect, troubleshoot and rectify routine issues with systems

• Ability to quickly learn new computer technology software packages with minimal training

• Expertise on general records management and archiving strategies

• Advanced written and verbal communication skills

• Ability to work with established procedures and to establish processes and procedures as needed, including those specific for working in a regulated environment.

• Motivated self-starter with the ability to perform independently or in teams in a fast-paced environment in response to business-critical assignments

• Ability to work effectively in a matrix organization and partner effectively with remote stakeholders and peers

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):

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.