Job Description

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. A Day in the Life The Senior Regulatory Affairs Specialist will play a key role in support of sustaining the Advanced Energy product portfolio. Sustaining regulatory responsibilities include reviewing product labeling for regulatory compliance, assessing and documenting decisions for device changes, reviewing new and modified regulations and guidance documents, ensuring accuracy of device technical documentation, and supporting regulatory compliance activities. The Senior Specialist has primary responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide for electrosurgical devices (e.g., electrosurgical generators, vessel sealing devices). This position is most suited for individuals with a broad background covering the total regulatory life cycle of medical devices. Location: Remote from the U.S. Responsibilities: Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. Leads or compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. May direct interaction with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications. Required Knowledge and Experience: Bachelor's degree with 4+ years of regulatory affairs experience. OR an advanced degree with 2+ years of regulatory affairs experience. Nice to Have: Previous experience with Medtronic. Demonstrated history of successful regulatory submissions in the US and EU (510(k), EU MDR Technical Documentation) and pre-submission meetings. Strong understanding of product development process and design control through knowledge of US FDA and international medical device regulations. Prior direct involvement with product development teams. Experience with regulatory support of clinical trials for medical devices. Working knowledge of IEC 60601-series standards. Previous experience with software-driven devices. Knowledge of MDSAP, ISO 13485, MDR audit requirements. Strong interpersonal, analytical, writing, and organizational skills, including the ability to “navigate the grey.” Ability to analyze and resolve non-routine regulatory issues using independent judgment. Working knowledge of FDA requirements, guidance documents, EU Medical Device Regulation (EU 2017/745), ISO 14971, ISO 13485, and other global regulatory requirements and quality standards. 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. Benefits & Compensation Medtronic offers a competitive Salary and flexible Benefits Package. We recognize our employees’ contributions and offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD): $88,800.00 - $133,200.00. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. About Medtronic 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. 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. #J-18808-Ljbffr Bronze Technologies, Inc.

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