Medtronic
Senior Regulatory Affairs Specialist
Medtronic, Boulder, Colorado, United States, 80301
Medtronic Senior Regulatory Affairs Specialist Boulder, Colorado Apply Now
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 LifeThe Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for collaborating, planning and executing regulatory activities related to the Basic Energy and Access and Instrument product portfolio modifications. Activities include submissions (e.g., 510(k), CE technical file), regulatory compliance assessments, compile international submissions and supporting EU MDR implementation. The Sr. RAS MDR role translates regulatory requirements into project/product requirements and collaborates cross-functionally, while ensuring timely and high-quality execution of assigned regulatory deliverables. This position is most suited for individuals with a broad background covering the total regulatory life cycle of medical devices and strong working knowledge and experience with reviewing advertising and promotional materials for medical devices. The initial project scope for this employee will be related to regulatory sustaining activities. NPD activities may be tied into the role later on.Location: Strong preference to have candidates work hybrid from Boulder, CO. Remote within the U.S. may be considered for the right candidate.Responsibilities may include the following and other duties may be assigned:Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering both domestic and international regulations.Prepare 510(k) submissions and technical documents to support CE mark and other international submissions.Participate in negotiations and interactions with regulatory authorities during the development and review process.Provide business and product information to the international regulatory affairs team to enable development and strategies and requirements and communicate that information to the business team.Support international product registrations as needed.Manage multiple projects and prioritize tasks on a day-to-day basis to meet project schedules.Interface with engineering, quality, clinical, marketing, and other functions as needed to fulfill responsibilities.Review promotional and advertising material.Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards.Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements.Participate in internal and external audits as needed.Maintain Regulatory affairs documentation to support compliance with applicable regulatory requirements.Direct or perform coordination and preparation of document packages for regulatory submissions from all areas of the company, internal audits, and inspections.Lead or compile all materials required in submissions, license renewal, and annual registrations.Keep abreast of regulatory procedures and changes.May direct interaction with regulatory agencies on defined matters.Perform other duties as assigned or required.Required Knowledge and Experience:Bachelors degree with 4+ years of regulatory affairs experience in the medical device, biotech or pharmaceutical industry.ORAn advanced degree with 2+ years of regulatory affairs experience in the medical device, biotech or pharmaceutical industry.Nice to Have:Knowledge of FDA and EU MDR requirements.Experience of working with all classifications of product in the U.S and/or EU.Design Dossier and/or Technical Documentation experience.Technical Writing.International medical device regulatory submission/approval experience, to include FDA and EU (specifically EU MDR).Product Labeling requirements and standards.May have practical knowledge of project management.Systems Knowledge such as RA systems, Agile, SharePoint, or Quality Management Systems.Physical Job Requirements:The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.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.A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We 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.We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves.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.
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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 LifeThe Senior Regulatory Affairs Specialist (Sr. RAS) is responsible for collaborating, planning and executing regulatory activities related to the Basic Energy and Access and Instrument product portfolio modifications. Activities include submissions (e.g., 510(k), CE technical file), regulatory compliance assessments, compile international submissions and supporting EU MDR implementation. The Sr. RAS MDR role translates regulatory requirements into project/product requirements and collaborates cross-functionally, while ensuring timely and high-quality execution of assigned regulatory deliverables. This position is most suited for individuals with a broad background covering the total regulatory life cycle of medical devices and strong working knowledge and experience with reviewing advertising and promotional materials for medical devices. The initial project scope for this employee will be related to regulatory sustaining activities. NPD activities may be tied into the role later on.Location: Strong preference to have candidates work hybrid from Boulder, CO. Remote within the U.S. may be considered for the right candidate.Responsibilities may include the following and other duties may be assigned:Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering both domestic and international regulations.Prepare 510(k) submissions and technical documents to support CE mark and other international submissions.Participate in negotiations and interactions with regulatory authorities during the development and review process.Provide business and product information to the international regulatory affairs team to enable development and strategies and requirements and communicate that information to the business team.Support international product registrations as needed.Manage multiple projects and prioritize tasks on a day-to-day basis to meet project schedules.Interface with engineering, quality, clinical, marketing, and other functions as needed to fulfill responsibilities.Review promotional and advertising material.Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards.Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements.Participate in internal and external audits as needed.Maintain Regulatory affairs documentation to support compliance with applicable regulatory requirements.Direct or perform coordination and preparation of document packages for regulatory submissions from all areas of the company, internal audits, and inspections.Lead or compile all materials required in submissions, license renewal, and annual registrations.Keep abreast of regulatory procedures and changes.May direct interaction with regulatory agencies on defined matters.Perform other duties as assigned or required.Required Knowledge and Experience:Bachelors degree with 4+ years of regulatory affairs experience in the medical device, biotech or pharmaceutical industry.ORAn advanced degree with 2+ years of regulatory affairs experience in the medical device, biotech or pharmaceutical industry.Nice to Have:Knowledge of FDA and EU MDR requirements.Experience of working with all classifications of product in the U.S and/or EU.Design Dossier and/or Technical Documentation experience.Technical Writing.International medical device regulatory submission/approval experience, to include FDA and EU (specifically EU MDR).Product Labeling requirements and standards.May have practical knowledge of project management.Systems Knowledge such as RA systems, Agile, SharePoint, or Quality Management Systems.Physical Job Requirements:The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.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.A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We 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.We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves.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.
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