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Senior Regulatory Affairs Specialist - Global Peripheral Vascular HealthLocation:Plymouth, Minnesota, United StatesRequisition #:21000SR6Post Date:5 hours agoSENIOR REGULATORY AFFAIRS SPECIALIST - Global Peripheral Vascular HealthPeripheral Vascular Health therapies are a critical part of the Medtronic vascular portfolio, treating patients with a broad range of conditions, including Peripheral and Carotid Disease, End Stage Renal Disease, Peripheral Embolization, and Superficial and Deep Venous Disease. This position will reside in the Peripheral Vascular Health organization.Join 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.Careers that Change Lives:The Senior Regulatory Affairs Specialist is responsible for worldwide regulatory activities to introduce new products (Class II and Class III) to market, maintain existing products and provide advice on regulatory requirements. The Senior Regulatory Affairs Specialist is responsible for assessing device changes for regulatory implications and for performing relevant regulatory actions in support of the implementation of these changes. This role focuses on a wide variety of regulatory tasks to allow the Senior Regulatory Affairs Specialist to make the most of his/her existing knowledge base while growing his RA skill set through daily activities conducted within a collaborative team environment. The Senior Regulatory Affairs Specialist reports to the Regulatory Affairs Manager.A Day In The Life:Collaborate with the US Operating Unit Regulatory Affair team and international regulatory colleagues to provide regulatory support for new products/therapies or changes to existing products. Works with engineers and technical experts to address questions from regulatory agencies. Lead or compile all materials required in submissions and license renewals.
Directs or performs coordination and preparation of document packages for regulatory submissions.
Provides support to currently marketed products as necessary. This includes reviewing labeling, product or process changes as well as supportive documentation for changes requiring RA agency review. Prepares submissions and compliance reports for FDA, Notified Bodies or provides support and documentation for international submissions.
Maintains proficiency in worldwide regulatory requirements. Obtains and distributes updated information regarding worldwide laws, guidelines, and standards.
Establishes and maintains good relationship within the RA department, cross functional teams and assists in developing and maintaining positive relationships with internal and external reviewers through oral and written communications.
Supports regulatory compliance activities, including internal or external audits, post-market surveillance activities, etc. as needed.
Supports product development programs.
Communicates directly with the FDA or other regulatory agencies for assigned projects.
Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
May act as a mentor to colleagues or may direct the work of other lower-level professionals.
Other tasks, as assigned.
Must Have: Minimum RequirementsBachelors degree in Regulatory Science, Pharmaceutical, Biomedical or related medical/scientific field
Minimum of 4 years of medical device regulatory experience
Or advanced degree with a minimum of 2 years medical device regulatory experience
Nice to have:Experience working with Class II/III medical devices
Experience with regulatory support of clinical trials.
Experience with FDA requirements (PMA, 510k, etc), China, Canada and Japan requirements, guidance documents, Medical Device Directive (MDD), Medical Device Regulation (MDR), and/or other global regulatory requirements and quality standards.
Effective negotiation and written/oral communication skills.
Effective interpersonal, organizational and time management skills.
Effective and respectful team member.
Detail-oriented
Solution-oriented.
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.
Full-time