Principal Regulatory Affairs Specialist - Enabling Technologies (remote)

Principal Regulatory Affairs Specialist - Enabling Technologies (remote)Location:Louisville, Colorado, United StatesRequisition #:21000TKMPost Date:1 day agoPRINCIPAL REGULATORY AFFAIRS SPECIALISTEnabling Technologies , delivering an innovative portfolio that includes advanced imaging ,navigation (https://www.medtronic.com/us-en/healthcare-professionals/products/neurological/surgical-navigation-systems/stealthstation.html) ,robotics (https://www.medtronic.com/us-en/patients/treatments-therapies/spinal-surgical-robotics.html) , customized implants, and pre-operative planning aided by artificial intelligenceJoin a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. Its no accident we work hard to cultivate a workforce that reflects our patients and partners. We believe its the only way to drive healthcare forward and remain a global leader in medical technology and solutions.To learn more about Inclusion Diversity at MedtronicClick Here (https://www.medtronic.com/us-en/about/careers/diversity-inclusion.html)Careers that Change LivesThis role focuses on regulatory support for global markets, with a wide variety of regulatory tasks to allow you to make the most of your existing knowledge base while growing your Regulatory Affairs (RA)  skillset every day. In this role, you will have primary RA responsibility for multiple Class II and/or Class III products, working within a collaborative team environment that fosters professional development while focusing on meeting business objectives with excellence. From developing and authoring regulatory submissions to providing critical input on cross-functional project teams, this role is an excellent opportunity for the right regulatory professional to take their career to the next level at the worlds leading medical device company.A Day in the LifeThe Principal Regulatory Affairs Specialist(RAS) helps develop and execute strategies for global regulatory approvals to introduce new and modified medical devices to the market for the Enabling Technologies business. The RAS translates regulatory requirements into project/product requirements, prepares regulatory submissions, and negotiates their approval with regulatory agencies as required.  Primary responsibilitiesinclude:preparing US, EU and international regulatory submissions; providing documentation for international submissions; supporting post-market regulatory compliance activities; evaluating proposed product changes for regulatory impact, all while ensuring timely and high-quality execution of assigned regulatory deliverables.Responsibilities may include the following and other duties may be assigned.Responsible for coordinating the planning, preparation, assembly,reviewand publication of regulatory submissions to the FDA and other worldwide government agencies. Must be able to write regulatory justifications to support submission filing decisions.

Compile all materials required for submissions, license renewals and annual registrations.

Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability.

Interact with regulatory authorities during the development and review process to ensure submission approval.

May be included as RA Representative on project teams with members of development project teams as necessary to communicate regulatory submissions requirements and preparations according to a defined timeline.

Recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.

Review and approve product labeling and promotional materials, per company procedures, to assure compliance with regulatory requirements.

Maintain current knowledge of the development and changes to applicable laws,regulationsand industry standards, and assist in the dissemination of this information to the appropriate individuals with the company.

Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.

Other duties as assigned.

Must Have (Minimum Requirements):Bachelors Degree and a minimum of 7years regulatory affairs, medical device or quality experience,

Or advanced degree with 5years experiencein regulatory affairs, medicaldeviceor quality

NiceToHave (Preferred Qualifications):Regulatory Affairs submission experience

Excellent analytical thinking skills

Ability to effectively manage multiple projects and priorities

Proven ability to work effectively in cross-functional teams

Excellent written and verbal communications skills

Ability to work in matrix teams

Strong organization and time management skills

Demonstrated ability to influence based on experience,factsand data

Project-management skills and experience

Presentation skills for small to mid-sized groups

Detail-oriented

Ability to be flexible with changing priorities

Submission-related word processing skills

About MedtronicTogether, 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. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.Physical Job RequirementsThe 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.