Medtronic Principal Regulatory Operation Specialist in Louisville, Colorado
Principal Regulatory Operation Specialist
Louisville, Colorado, United States
Feb 24, 2021
PRINCIPAL REGULATORY OPERATIONS SPECIALIST
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.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.
Careers that Change Lives
T he Principal Regulatory Operations Specialist will lead process improvement and harmonization efforts across the Regulatory Operations Department, supporting submissions, developing, implementing and maintaining systems to capture key performance metrics,as well as streamliningproduct release activities for both US and International markets. The individual will be supporting multiple business across different time zones and requires the ability to work with and support various teams in a remote setting.
The successful candidate will be instrumental in creating and executingnew and improved regulatory operations strategies, and streamlining activities related to product releases and publishing, as well ascoach 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, be responsible for leading workstreams, requiring delegation of work and review of others' work product.
A Day In The Life
Responsible for the preparation, publication, quality control, and delivery of paper and electronic components of all submissions including initial large marketing authorization applications and electronic common technical documents (e-CTD).
Submissions are produced with electronic publishing tools in compliance with document management standards.
Prepares, submits, tracks, indexes and archives paper and electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials.
Provide tools, training and overall support to submission stakeholders in order to capture key performance metrics.
Responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, and providing input to systems designs
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.
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
Must Have; Minimum Requirements
Minimum 7 years of medical device experience with work experience in regulatory affairs/regulatory operations or quality with Bachelor’s degree.
Or minimum 5 years of medical device experience with work experience in regulatory affairs/regulatory operations or quality with Master’s degree.
Nice To Have
Experience with Agile, Documentum or other document management systems used in the medical device or pharmaceutical industry
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.
Experience with GTS licensing and UDI coordination and knowledge of EU MDR.
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.
Physical Job Requirements
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. (ADA-United States of America)
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.