J&J Family of Companies Senior Regulatory Affairs Specialist Oklahoma City , Oklahoma Apply Now Senior Regulatory Affairs Specialist - 2406173183WDescriptionAbiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist. Remote work options may be considered on a case-by-case basis and if approved by the CompanyAbiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's 'Patients First!' culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.The Senior Regulatory Affairs Specialist will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices. You will advise on regulatory requirements as a key member of cross-functional teams, prepare and review FDA submissions, and interact with and respond to FDA pre-submission and during the review period. Through your engagement in this role, you will help shape the life-saving field of heart recovery.The ideal candidate will:Be passionate about Regulatory Affairs impact in support of the research, development, clinical, marketing, and production of state-of-the-art class III cardiovascular medical devicesBe energized by joining a world-class company and regulatory teamEnjoy teamwork and thrive as a member of dynamic cross-functional teamsBuild and maintain strong interpersonal relationships within and outside of the companyExhibit leadership traits- positive, forward looking, accountable, action-oriented, delivering resultsAdaptable and thrive in a dynamic work environment where variety is the routine.Embrace change, continuous learning, and work skills improvementKey Responsibilities:Support cross-functional new product development projects and lead compilation of all materials required for submissions to FDAProvide ongoing support to project teams for regulatory issues and questions. Find, interpret and apply regulations and guidance appropriately for situationsProvide regulatory support for currently marketed products as necessary to ensure ongoing complianceProvide support for changes to existing products, including providing regulatory assessment of changes, and subsequent regulatory filingsDevelop solutions to a variety of technical problems. Actively participate in problem solving discussions and recommend solutionsKeep abreast of FDA guidance documents and regulations and monitor impact of changing regulations on submission strategiesAssist in the maintenance and improvement of regulatory SOPsInteract and negotiate with regulatory agencies on defined matters as neededQualificationsEducationDegree in engineering or science requiredAdvanced degree is preferredRequiredMinimum of 4 years with a Bachelor's degree or Minimum of 3 years with an advanced degreeRegulatory affairs experience in the medical device industry with a track record of successful submissionsExperience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory complianceHistory of successful IDE/PMA/510(k) device submissions (Class III device submissions preferred)Experience with FDA requirements, guidance documents, ISO 14971, ISO 13485, IEC 60601, IEC 62304Ability to effectively manage multiple projects and prioritiesStrong communication and regulatory writing skillsStrong problem solving skills, interpersonal skills and effective team memberResults oriented. Ability to drive to completion in adherence to aggressive project schedulesPreferredAbility to comprehend principles of engineering, physiology and medical device use. Cardiovascular device experienceCertification is a plus (such as RAC from the Regulatory Affairs Professionals Society)OtherTravel up to 10%Must be able to effectively work remotelyThis job posting is anticipated to close on 3.20.2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $104,000 to $140,000. The Company maintains highly competitive, performance-based compensation programs. Additional information can be found through the link below. For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefitsJohnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.#J-18808-Ljbffr

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