Principal Regulatory Operations Specialist - Medtronic Diabetes Group
The Principal Regulatory Operations Specialist will lead process improvement efforts across the Regulatory Affairs Department, supporting submissions, developing, implementing and maintaining systems to capture key performance metrics, as well as streamlining product release activities for both US and International markets.
The successful candidate will be instrumental in creating and executing new and improved regulatory operations strategies, and streamlining activities related to UDI submissions, GTS licensing, product release, and transition to EU MDR, as well as coach and review the work of lower level specialists and provide functional leadership and audit readiness in support of internal and external inspections. The individual will manage multiple projects, requiring delegation of work and review of others' work product.
A Day in the Life / Responsibilities:
- Develop and implement business processes to improve the overall effectiveness of the Regulatory Affairs function.
- Evaluate new and modified regulatory systems and procedures, and lead efforts to improve activities related to GTS licensing, UDI submissions, product release and the EU MDR transition
- Provide tools, training and overall support to submission stakeholders in order to capture key performance metrics
- Solve and prevent issues with systems and processes within tight timelines.
- Drive functional collaboration to identify topics or trends that require escalation to functional senior leadership
- Assist in the creation, deployment and maintenance of Regulatory procedures and training programs
- Maintain and improve regulatory systems to ensure data integrity, resolving data inconsistencies and producing various reports as needed
- Identify, maintain and update standard operating procedures, policies, work instructions, and user guides, as needed.
- Develop and implement operational strategy, in cooperation with management, to archive correspondence, submissions, approvals, and other department regulatory documents, ensuring standardization, compliance, and integrity of records.
- Monitor and analyze the impact of new or changing regulations, law enforcement actions and other changes that impact product regulation around the world
- Lead special projects under the direction of management.
- Improve regulatory affairs activities related to electronic submissions and internal procedures including business process/system integration.
- Initiate special projects with minimal direction from manager including collecting and analyzing data, and presenting results
- Develop key partnerships across functional groups and business units to ensure best practices.
- Participate and guide decision-making process for IT system enhancements and new support software implementation within regulatory affairs
Medtronic Diabetes Group
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
Visit www.medtronicdiabetes.com to see an overview of the products in our Diabetes product portfolio.
We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.
Medtronic is a $29.7b company with 90,000+ employees in more than 160 countries.
Come for a job. Stay for a career.
MINIMUM REQUIRED QUALIFICATIONS (MUST BE EVIDENT ON YOUR RESUME):
- Bachelor's degree
- 7+ years of medical device experience with work experience in regulatory affairs/regulatory operations or quality with Bachelor's degree.
- 5+ years of medical device experience with work experience in regulatory affairs/regulatory operations or quality with Master's degree.
- Experience with Agile, Documentum or other document management systems used in the medical device or pharmaceutical industry
- Experience with GTS licensing and UDI coordination and knowledge of EU MDR.
- Experience with Internet/Intranet technology and interactive software applications such as SharePoint and InfoPath.
- Advanced to expert level knowledge and use of Microsoft Office Suite applications, Outlook, Word, Adobe Acrobat, and Excel
- Ability to quickly learn new computer technology software packages with minimal training
- Experience working with technical documentation and design dossiers
- Analytical and problem-solving skills associated with software and complex documents, including the ability to detect, troubleshoot and rectify routine issues with systems
- Expertise on general records management and archiving strategies and capturing metrics
- Expert project management skills; ability to efficiently manage multiple projects and priorities, including meticulous attention to detail and the ability to complete multiple simultaneous assignments within a given period of time and with minimal supervision.
- Excellent written and verbal communication skills
- Strong customer service skills to interact with individuals at various levels of the organization and external contacts when necessary
- Ability to work with established procedures and to establish processes and procedures as needed, including the ability to understand policies and procedures necessary when 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.
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.
- 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.
- Must be able to travel independently to various Medtronic buildings/sites.
- Must be able to travel by plane and by car.(