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.
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 support 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
Desired/Preferred Qualifications
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 knowledge 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.
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.
Medtronic benefits and compensation plans
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.